Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: Kaiser Permanente

 
1 of 61 
Version 1.9 
 
 
January 2024 
Study Protocol 
 
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults  
(BackinAction) 
 
 
Principal Investigators:   
Andrea J. Cook, PhD 
Senior Investigator 
Kaiser Permanente Washington Health Research Institute 
 
Lynn L. DeBar, PhD, MPH 
Distinguished Investigator 
Kaiser Permanente Center for Health Research 
 
 
 
 
 
Supported by:  
The National Center for Complementary and Integrative Health 
1UH3 AT010739 
 
May 30, 2020 
 

 
2 of 61 
Version 1.9 
 
 
January 2024 
Tool Revision History 
Version Number: 1.2 
Version Date: May 7, 2021 
Summary of Revisions Made:  
1. Updated the Study Team Roster to reflect the current team 
2. Added an additional inclusion and an additional exclusion criterion  
3. Revised Outcome Measures to streamline questionnaire/reduce participant burden 
(remove PROMIS Pain Intensity, Pain Interference, Anxiety, Depression and replace 
with PEG, PHQ-4) 
4. Updated the Precis and Study objectives to reflect use of the PEG as a core secondary 
outcome measure 
5. Minor modifications and clarifications on recruitment and consenting procedures and 
connecting patients with acupuncturists for the first visit 
6. Minor modification on compensation schedule for interviews. The total amount remains 
the same, but prospective participants are now paid for the baseline assessment ($15) 
and each major follow-up assessment is $5 less than originally proposed 
7. Clarification regarding the electronic assessments of hospitalizations for SAE’s that are 
at least probably related to acupuncture 
8. Minor clarification re data management 
9. Updated the reporting requirements for reportable events to align with KPNC IRB 
requirements 
Version Number: 1.3 
Version Date: June 23, 2021 
Summary of Revisions Made: 
1. Added an inadvertently omitted exclusion criterion from the screener (a fever most days 
in the last month), which is red flag of serious underlying illness 
2. Removed any remaining references to former measures of pain intensity and pain 
interference and replaced them throughout with the 3-item PEG, which is now an 
outcome for the baseline and all follow-up questionnaires 
3. Clarified a few questions related to recruitment, randomization and Serious Adverse 
Event reporting 
Version Number: 1.4 
Version Date: July 7 
Summary of Revisions Made:  
1. Clarified in a few more places that the biostatisticians will be masked to treatment group 
assignment until the data base is locked.  
Version Number: 1.5 
Version Date: March 2022 
Summary of Revisions Made:  

 
3 of 61 
Version 1.9 
 
January 2024 
1. Updated information related to aim 3 to conduct optional, one-time, 60-minute phone 
interviews with study participants to learn about their study and acupuncture 
experiences. 
2. Updated the protocol for clarity and consistency with current IRB-approved processes. 
3. Updated study team roster. 
 
 
Version 1.6 
Version Date: June 2022 
Summary of Revisions Made: 
 
1. Updated aim 3 with modest change to scope with elimination of patient interviews to be 
conducted later in the study to corroborate findings from earlier patient interviews 
(summative evaluation). 
2. Updated study team roster.  
3. Updated recruitment targets to reflect a possible increase in total study enrollment in 
addition to possible increases in recruitment targets at individual sites. 
4. Updated study measures table to be consistent with approved procedures for use of 
acupuncture and adverse event questions. 
 
Version 1.7 
Version Date: January 2023 
Summary of Revisions Made: 
 
1. Updated PIs listed on cover page. 
2. Updated study team roster. 
3. Included language to distinguish the participant formative interviews from the acupuncturist 
formative surveys and interviews. 
 
Version 1.8 
Version Date: September 2023 
Summary of Revisions Made: 
 
1. Added statement that the cost-effectiveness analysis will be conducted by Dr. Patricia 
Herman at RAND using de-identified data. 
2. Changed institutional affiliation of Alice Pressman to KP School of Medicine. 
 
Version 1.9 
Version Date: January 2024 
Summary of Revisions Made: 
 
1. Included details of the stakeholder interviews.  
2. Added data sharing section describing planned public release database. 
3. Added new study team member at RAND. 

 
4 of 61 
Version 1.9 
 
January 2024 
LIST OF ABBREVIATIONS 
AAP 
Acupuncture Advisory Panel 
AE 
Adverse Event/Adverse Experience 
CEC 
Core Executive Committee 
CFR 
Code of Federal Regulations 
CPT 
Current Procedural Terminology 
cLBP 
Chronic Low Back Pain 
CMS 
Centers for Medicare and Medicaid Services 
CRC 
Clinical Research Coordinator 
DSMB 
Data and Safety Monitoring Board 
EA 
Enhanced Acupuncture 
EBT 
Evidence Based Treatment 
EHR 
Electronic Health Record 
FQHC 
Federally Qualified Health Center 
GAD-2 
Generalized Anxiety Disorder 2-item screener 
GEE 
General Estimating Equations 
HCS 
Health Care System (refers to IFH, KPNC, KPWA, SH) 
HHS 
Health and Human Services 
HIPAA 
Health Information Portability and Accountability Act 
ICD 
International Classification of Diseases 
ICH 
International Conference on Harmonization 
IFH 
Institute for Family Health 
IMC 
Independent Monitoring Committee 
IRB 
Institutional Review Board 
KPNC 
Kaiser Permanente Northern California 
KPWA 
Kaiser Permanente Washington 
LBP  
Low Back Pain (duration unspecified) 
NCCIH 
National Center for Complementary and Integrative Health, NIH 
NIA 
National Institute of Aging, NIH 
NIH 
National Institutes of Health 
NIH HCS-CCC 
NIH Health Care Systems Collaboratory Coordinating Center 
OHRP 
Office of Human Research Protections 
OA 
Older Adults (65 and older) 
PC/PCP 
Primary Care / Primary Care Provider  

 
5 of 61 
Version 1.9 
 
January 2024 
PEG  
Pain, Enjoyment, General Activity (pain scale) 
PHQ-2 
Patient Health Questionnaire 2-item depression screener 
PI 
Principal Investigator 
PM 
Project Manager 
PROMIS 
Patient Reported Outcomes Measurement Information System 
PRO 
Patient-Reported Outcomes 
RE-AIM 
Reach, Effectiveness – Adoption, Implementation, Maintenance 
RMDQ 
Roland Morris Disability Questionnaire 
RTF 
NIH Research Task Force for Low Back Pain 
SA 
Standard Acupuncture 
SAE 
Serious Adverse Event/Serious Adverse Experience 
sFTP 
Secure File Transfer Protocol 
sIRB 
Single IRB (required for multi-site trials) 
SH 
Sutter Health 
SID 
Study Identifier 
SMC 
Statistical Methods Committee 
STRICTA 
Standards for Reporting Interventions in Clinical Trials of Acupuncture 
UMC 
Usual Medical Care 

 
6 of 61 
Version 1.9 
 
January 2024 
TABLE OF CONTENTS 
Page 
Study Protocol ......................................................................................................................... 1 
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults ...................... 1 
Tool Revision History ............................................................................................................... 2 
LIST OF ABBREVIATIONS ....................................................................................................... 4 
TABLE OF CONTENTS ............................................................................................................ 6 
STUDY TEAM ROSTER ......................................................................................................... 9 
PARTICIPATING STUDY SITES ........................................................................................ 10 
1. STUDY OBJECTIVES ..........................................................................................................13 
1.1 
Aim 1: Primary Objective .......................................................................................... 13 
1.2 
Aim 1: Secondary Objectives ................................................................................... 13 
2. BACKGROUND AND RATIONALE......................................................................................13 
2.1 Background on Condition, Disease, or Other Primary Study Focus ....................... 13 
2.2 Study Rationale................................................................................................................ 14 
3. STUDY DESIGN ...................................................................................................................15 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ......................................................16 
4.1 Inclusion Criteria .............................................................................................................. 16 
4.2 Exclusion Criteria ............................................................................................................. 17 
5. STUDY INTERVENTIONS ....................................................................................................22 
5.1 Interventions, Administration, and Duration ................................................................ 22 
5.2 
Handling of Study Interventions ............................................................................... 25 
5.3 
Concomitant Interventions ........................................................................................ 25 
5.3.1 Allowed Interventions ............................................................................................... 25 
5.3.3 Prohibited Interventions ............................................................................................ 25 
5.4 
Assessment of Adherence ........................................................................................ 25 
6. STUDY PROCEDURES ........................................................................................................26 
6.1 
Schedule of Evaluations ............................................................................................ 26 
6.2  Description of Evaluations ............................................................................................ 27 
6.2.1 Screening Evaluation ................................................................................................ 27 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 28 

 
7 of 61 
Version 1.9 
 
January 2024 
6.2.4 Follow-up Assessments ............................................................................................ 35 
6.2.5 Completion/Final Evaluation .................................................................................... 35 
7. SAFETY ASSESSMENTS ....................................................................................................35 
7.2   Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters .............................................................................................................................. 36 
7.4  Reporting Procedures .................................................................................................... 38 
7.5 Follow up for Adverse Events ........................................................................................ 38 
7.6  Safety Monitoring............................................................................................................ 39 
8. INTERVENTION DISCONTINUATION .................................................................................39 
9. STATISTICAL CONSIDERATIONS ......................................................................................39 
9.1  General Design Issues .................................................................................................. 39 
Aim 2 Objective: To conduct a cost-effectiveness analysis of enhanced acupuncture 
and standard acupuncture compared to usual care. ........................................................ 39 
9.2  Sample Size and Treatment Assignment Procedures.............................................. 39 
Treatment Assignment Procedures ....................................................................................... 40 
9.3   Definition of Populations .............................................................................................. 41 
9.4   Interim Analyses and Stopping Rules ........................................................................ 41 
9.5   Outcomes ....................................................................................................................... 41 
9.5.1 Aim 1: Primary Outcome .......................................................................................... 41 
9.5.2 Aim 1: Secondary Outcomes .................................................................................... 41 
10. DATA COLLECTION AND QUALITY ASSURANCE .........................................................45 
10.1 
Data Collection Forms ............................................................................................... 45 
10.2 
Data Management ...................................................................................................... 45 
10.3 Quality Assurance ......................................................................................................... 47 
10.3.1 Training ..................................................................................................................... 47 
10.3.2 Quality Control Committee....................................................................................... 48 
10.3.3 Metrics ...................................................................................................................... 48 
10.3.4 Protocol Deviations ................................................................................................... 49 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................49 
11.1 Institutional Review Board (IRB) Review ................................................................... 49 
11.2 Informed Consent Forms ............................................................................................. 49 
11.3 Participant Confidentiality ............................................................................................ 50 
11.4 Study Discontinuation ................................................................................................... 51 

 
8 of 61 
Version 1.9 
 
January 2024 
12. COMMITTEES ....................................................................................................................51 
13. PUBLICATION OF RESEARCH FINDINGS .......................................................................52 
14. DATA SHARING.................................................................................................................52 
15. SUPPLEMENTS/APPENDICES .........................................................................................61 
1. Acupuncture Treatment Protocol with Acupoints ............................................................61 
I.Acupuncture Intervention Guidelines with Acupoints 
II. Acupuncture Treatment Visit Form 
III. Informed Consent Form Template (not yet available) 

 
9 of 61 
Version 1.9 
 
January 2024 
STUDY TEAM ROSTER  
Name 
Address 
Kaiser Permanente 
Washington Health 
Research Institute 
1730 Minor Avenue 
Suite 1600, Seattle, 
WA 98101 
  
  
Phone number 
Fax  
Email 
Andrea Cook, PhD 
(Multiple PI; 
Biostatistician) 
(206) 287-4257 
 
andrea.j.cook@kp.org 
Clarissa Hsu, PhD 
(Qualitative Researcher) 
(206) 287-4276 
clarissa.w.hsu@kp.org 
Douglas Kane 
(206) 442-4075 
douglas.e.kane@kp.org 
Carolyn Eng, PhD 
(919) 225-0778 
 
carolyn.m.eng@kp.org 
Robert Wellman, MS 
(206) 287-2557 
robert.d.wellman@kp.org 
Laurel Hansell 
(206) 442-5208 
laurel.d.dillon-sumner@kp.org 
Morgan Justice, MA 
(256) 508-4613 
 
morgan.j.fuoco@kp.org 
Annie Piccorelli, PhD 
(206) 287-2885 
 
Annie.V.Piccorelli@kp.org 
Chi Tran, MHI 
 
 
chi.q.tran@kp.org 
Luesa Healy 
(206) 287-2794 
 
luesa.l.jordan@kp.org 
Juanita Trejo, MPH 
(206) 287-2329 
 
juanita.i.trejo@kp.org 
Kaiser Permanente 
Center for Health 
Research 
3800 North Interstate 
Portland, OR 97227 
 
 
 
Phone number 
Fax 
Email 
Lynn DeBar, PhD, MPH 
(Multiple PI) 
(206) 287-2426 
 
lynn.debar@kpchr.org 
Sutter Health                       
Research Development 
and Dissemination               
Center for Health Systems 
Research 
2121 North California 
Blvd Suite 310, 
Walnut Creek, CA 
94596 
  
  
Phone number 
Fax 
Email 
Katie Stone, PhD, MA 
(Site PI) 
(833) 942-2844 
 
StoneKL@sutterhealth.org 
Shruti Vaidya, MS 
(925) 287-4031 
vaidyas@sutterhealth.org 
Lisa Dean 
deanl@sutterhealth.org 
Alex Scott 
 
 
alex.scott@sutterhealth.org 
The Institute for Family 
Health 
230 West 17th Street, 
New York, NY 10011 
  
  
Phone Number 
Fax  
Email 

 
10 of 61 
Version 1.9 
 
January 2024 
Ray Teets, MD (Site PI) 
(212) 206-5200 
347-917-1906 
rteets@institute.org 
Arya Nielsen, PhD 
(Acupuncture Expert) 
(914) 388-2816 
arya@guasha.com 
Arya.Nielsen@mountsinai.org  
Matthew Beyrouty, MPA 
(212) 659-1409 
212-659-9071 
mbeyrouty@institute.org 
Ariel Jacobs 
(646) 483-6558 
 
ajacobs@institute.org 
Donna Mah, DACM, Lac 
(Clinical Site Coordinator) 
 (917) 453-1778 
Mahdonnam@gmail.com 
Kaiser Permanente 
School of Medicine 
98 S. Los Robles 
Ave. Pasadena, CA 
91101 
 
 
 
Phone number 
Fax 
Email 
Alice Pressman, PhD, MS 
(925) 287-4018 
 
Alice.R.Pressman@kp.org 
Kaiser Permanente 
Northern California 
Division of Research 
2000 Broadway, 
Oakland, CA 94612 
  
  
Phone Number 
Fax 
Email 
Andrew Avins, MD, MPH 
(Site PI) 
(510) 891-3557 
510-891-3606 
andy.l.avins@kp.org 
Gabriela Sanchez 
(510) 891-3435 
(855) 414-2842 
Gabriela.X.Sanchez@kp.org 
 
Mahesh Bulbule, MS  
(510) 891-5958 
510-891-3606 
Mahesh.S.Bulbule@kp.org 
RAND Corporation 
 1776 Main St, 
Santa Monica, CA 
90401 
  
  
Phone Number 
Fax 
Email 
Patricia Herman, PhD 
(Cost-effectiveness 
Expert) 
(310) 393-0411 
patricia_herman@rand.org 
Samuel Mann, PhD 
 
 
mann@rand.org 
 
PARTICIPATING STUDY SITES  
Please see above 

 
11 of 61 
Version 1.9 
 
January 2024 
PRÉCIS  
 
After a formative year to refine procedures, we will conduct a pragmatic trial of two types of 
acupuncture, standardized (SA) and enhanced (EA), compared to Usual Medical Care (UMC) in 
789 older adults. The randomized trial tests the value of both groups of acupuncture (SA, EA) 
for improving back pain related disability relative to usual medical care.  
 
Study Title  
 
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults 
 
Objectives  
 
1. Determine the effectiveness of a standard course of acupuncture (SA: up to 15 sessions of 
acupuncture over 3 months) and an enhanced course of acupuncture (EA: up to an additional 6 
sessions of acupuncture over months 4-6) in improving back-related disability in older adults 
with chronic low back pain (cLBP) compared to usual care alone. Key secondary aims are to 
determine the effectiveness of acupuncture in improving a composite score of pain intensity and 
pain interference. 
 
2. Determine the cost-effectiveness of both types of acupuncture versus usual medical care. 
 
3. Describe, understand and explain the barriers and facilitators to adoption, implementation, 
and sustainability of acupuncture treatment for older adults from patient and acupuncturist 
perspectives.  
 
Design and Outcomes   
 
In this pragmatic, three-arm parallel groups multi-site randomized controlled trial, we will recruit 
and randomize 789 adults ≥ 65 years of age with cLBP to SA, EA or UMC alone in four health-
care systems. These include two integrated health care systems (HCSs), a fee-for-service 
system and a network of federally qualified health centers.   
 
Objective 1 outcome data will be collected by questionnaire at 3-, 6-, and 12-months post-
randomization. In addition, short monthly surveys will capture data on physical function and a 
composite score of pain intensity and pain interference.  
 
Our primary outcome will be back-related dysfunction measured by the Roland Morris Disability 
Questionnaire and our primary timepoint will be 6 months. Key secondary outcomes include the 
PEG scale (a composite three-item scale assessing pain and pain interference). Other 
secondary outcomes will include the 6-item PROMIS physical function scale and patient global 
impression of change. Tertiary outcomes will include the two PROMIS 29 measures (fatigue, 
social function), the PHQ-4 screener for anxiety and depression and monthly measures of 
physical function and the PEG scale. We will collect data (EuroQol patient reported outcome 
scale and health care utilization from the electronic health record) for conducting a cost-
effectiveness analysis (Objective 2). We will collect qualitative data from interviews and focus 
groups that are pertinent to our third objective.  
 
Interventions and Duration  
 
SA will consist of 3 months (90 days) of acupuncture needling, with a proposed minimum of 8 

 
12 of 61 
Version 1.9 
 
January 2024 
treatments and a maximum of 15. EA will include the standard acupuncture plus an additional 3-
month maintenance period, with a proposed minimum of 4 additional acupuncture needling 
treatments and a maximum of six. UMC will consist of the care that individuals receive 
according to their insurance benefits plus anything else they pay for out of pocket. We will ask 
those assigned to UMC to avoid acupuncture for the year they are enrolled in the study. Both 
active treatment arms (SA, EA) will also have access to UMC as described above. Participants 
will be enrolled in the study for 12 months.  
 
Sample Size and Population  
 
We will include patients at least 65 years of age with uncomplicated cLBP with or without 
radiculopathy. We plan to enroll a total of 789 participants (263 per study arm), with the total 
number enrolled not to exceed 820 participants. Participants will be recruited from four health 
plans, with varying numbers of participants from each site.  Randomization will be stratified by 
health care system, age category and gender. We expect the racial and ethnic mix will roughly 
parallel that of the older Medicare population.  
 
 

 
13 of 61 
Version 1.9 
 
January 2024 
1. STUDY OBJECTIVES 
1.1 
Aim 1: Primary Objective 
We hypothesize that both types of acupuncture will result in improved back-related 
disability compared to usual medical care at 6 months. We further hypothesize that 
enhanced acupuncture will be superior to standard acupuncture, albeit not expected 
to be a clinically important difference.  
1.2 
Aim 1: Secondary Objectives 
To examine the effectiveness of acupuncture at 3 and 12 months for improving back-
related disability and to evaluate additional outcomes, including a composite score of 
pain interference and pain intensity at 3, 6 and 12 months.  
 
       1.3     Aim 2: 
 
To conduct a cost-effectiveness analysis of enhanced acupuncture and standard 
acupuncture compared to usual care.  
 
        1.4     Aim 3: 
To utilize qualitative methods to understand, describe and explain barriers and 
facilitators to adoption, implementation, and sustainability of acupuncture treatment 
for older adults from patient and acupuncturist perspectives.  
 
2. BACKGROUND AND RATIONALE 
 
2.1 Background on Condition, Disease, or Other Primary Study Focus 
 
Back pain is the leading cause of disability worldwide, with both prevalence and burden 
increasing with age.1 In the United States, about $86 billion is spent annually on direct costs of 
medical care for back/neck pain,2 with particularly marked escalating costs for back pain in older 
Americans (those at least 65 years of age). While the Medicare population increased only 42% 
between 1991 and 2002, expenditures for back pain increased 387%.3 Despite these large 
investments in care for back pain,4  the health and functional status of Americans with back pain 
has deteriorated.2 Roughly a quarter of older adults report low back pain5 with prognosis 
worsening with age.6 Persistent pain, typically lasting three months or longer, is the most 
consequential type of back pain. 
 
A critical gap exists in the evidence on the safety and effectiveness of treatments for older 
adults with cLBP. This gap is of particular concern because about 12% of adults age 65 and 
over suffer from impairing cLBP,7 the prevalence is increasing8 and older adults commonly have 
more disabling back pain than those under age 65.6 Many treatments considered appropriate for 
adults under age 65 may not be appropriate for older adults given their greater prevalence of 
comorbidities with attendant polypharmacy.9 In addition, burgeoning imaging rates reveal 
incidental pathology in many cases, placing older adults at risk for inappropriate invasive 
treatments.8,10 Because of normal physiological changes with aging (e.g., reduced tolerance of 
medications and increased prevalence of osteoporosis), older adults are at substantially 
increased risk of adverse effects of commonly used LBP treatments7,11-13 including medications 
(e.g., non-steroidal anti-inflammatory drugs [NSAIDs], muscle relaxants, and opioids) and 
complementary and integrative (CIM) treatments such as high velocity spinal manipulation 
techniques. While numerous randomized clinical trials (RCTs) have evaluated treatments for 

 
14 of 61 
Version 1.9 
 
January 2024 
chronic pain, their applicability to older adults is unclear because most of these RCTs included 
few, if any, older adults.   
 
Thus, research is needed to clarify the cLBP treatments that are safe and effective for older 
adults.  Evidence-based strategies that incorporate a biopsychosocial approach are 
recommended to address chronic pain most effectively for a general adult population.14,15 
Studies focused on nonpharmacological treatments may be especially beneficial, given 
concerns about medication safety.16 Research demonstrates that older adults are open to trying 
nonpharmacological therapies,17 yet few studies of these treatments are published.18 More 
research will help clinicians focus on the safest, most effective and most acceptable treatments 
for older adults, resulting in improved outcomes and fewer adverse experiences. 
 
Evidence-based guidelines from 201719 recommended 13 nonpharmacological treatments for 
cLBP, including acupuncture. Acupuncture is considered to have moderate evidence of 
effectiveness for improving pain and function compared to usual care.20 These therapies are 
now recommended as first-line therapy for cLBP.   
 
In a survey to evaluate the important outcomes for people with chronic pain, participants 
identified numerous aspects of daily life, including sleep quality, emotional well-being, ability to 
participate in everyday activities, enjoyment of life, decreased fatigue, and minimizing cognitive 
difficulties as things that were important to them.21 Some evidence exists that acupuncture 
treatment can improve many of these concerns, though studies are typically small and low 
quality. These outcomes may be especially important to older adults. 
 
2.2 Study Rationale 
 
Acupuncture has been found effective for cLBP in adults largely under 65 years old, with 
moderate effect sizes, using individual patient level data-analysis, with little diminution of 
effectiveness over 12 months of follow-up.22 However, few studies of acupuncture have either 
included or focused on adults 65 years of age and older. In an unpublished subgroup analysis 
from the individual patient level meta—analysis conducted by Acupuncture Trialist Collaboration 
that focused on LBP, Vickers (personal communication) found that only 2.4% of trial participants 
were 75 years or older. 
 
The optimal dose of acupuncture is unknown for any condition. Large trials of acupuncture for 
cLBP have typically included 1023-25 to 12 treatments 26,27 with some using up to 15.28-30 In a 
feasibility trial comparing different doses of acupuncture (4, 7, 10 treatments) for cLBP,31 the 
largest improvements in function, pain intensity, and pain bothersomeness were seen with 10 
treatments. Many trials have focused on acupuncture needling. Our standard course of 
acupuncture needling will include up to 15 visits over the course of 3 months. This maximum is 
based on the prior trials as well as the belief of acupuncturists that older adults with more co-
morbidities may take longer to improve. We will encourage acupuncturists to treat patients for a 
minimum of 8 treatments, which is based on data from the AADDOPT-2 trial.32 We will allow 
variability in the number of treatment sessions so that the acupuncturist and patient can, within 
the study guidelines, select the number of treatment sessions optimal for any particular patient. 
 
A critical question is whether long-term outcomes from a course of acupuncture can be 
improved by offering “maintenance treatment” over a longer period of time, as recommended 
clinically in some circumstances. No studies have examined this issue. We allow a maximum of 
six acupuncture needling treatments during this additional 3-month period, anticipating that the 
frequency of sessions will be tapered during the maintenance phase. We suggest that 

 
15 of 61 
Version 1.9 
 
January 2024 
acupuncturists see patients at least four times.  
 
We plan to compare our acupuncture groups (SA alone or EA [standard treatment followed by 
maintenance treatment] to UMC alone. Although there is no accepted standard treatment for 
cLBP in older adults, we have developed a flexible approach for our treatments with the help of 
an experienced Acupuncture Advisory Panel. Treatment parameters are described in more 
detail in Section 5. 
 
Acupuncture has an excellent safety profile. Several large studies collected data on adverse 
events (AEs) from more than 235,000 patients33,34 and studies involving more than 63,000 
treatments are reported from 156 providers.35,36 Collectively, this work found that minor AEs, for 
example bleeding or needle pain, are the most common, in the range of 1–10 in 100 for 
bleeding and hematoma, and 1–10 in 1000 for strong pain during needling.34 Hopton37 found no 
evidence that patients, who reported bothersome treatment reactions, were less willing to try 
acupuncture again than those who did not, suggesting that most patients perceive common AEs 
as minor. In a large trial of acupuncture for cLBP, 2.3% of patients reported a moderate AE that 
was likely due to treatment and 1 of 477 reported pain lasting one month.25 Serious AEs, such 
as pneumothorax, persistent nerve pain, or needle breakage are very rare (typically 1 in 
100,000 or less).34  
 
CMS recently published an Acupuncture-related National Coverage Decision for the treatment 
of chronic low back pain.38 Acupuncture is now covered by Medicare, and over time will become 
increasingly available to many older adults. In addition, older adults are interested in 
acupuncture39 and Medicare is interested in data on the value of acupuncture for older adults 
with cLBP. They cited the NIH plans to study this intervention in their National Coverage 
Decision. Acupuncture was cost-effective in two large cLBP trials.30,40 A critical question is 
whether long-term outcomes from a course of acupuncture can be improved by offering 
“maintenance treatment” for a period, as recommended clinically in some circumstances. No 
studies have examined this issue. This pragmatic RCT will offer clear guidance about the value 
of acupuncture for improving functional status and reducing pain intensity and pain interference 
for older adults with cLBP. This evidence will provide essential information for Medicare 
regarding their coverage decision and for individual physicians and patients deciding on a 
course of treatment. 
 
3. STUDY DESIGN 
 
We propose a three-arm multi-site parallel design, pragmatic trial with 789 participants to 
evaluate the effectiveness of two groups of acupuncture to improve functional outcomes 
(primary outcome), and pain intensity and pain interference (key secondary outcomes) of older 
adults (≥65 years) with cLBP. We will compare SA (3 months of acupuncture, with up to 15 
visits) and EA (3 months of SA, 3 months maintenance acupuncture with up to 6 visits) to UMC 
(each group, N=263). Participants will be recruited from four healthcare systems (HCSs): Kaiser 
Permanente Washington - KPWA and Kaiser Permanente Northern California - KPNC, which 
have Kaiser Permanente integrated health plans; Sutter Health- SH, a largely fee for service 
organization; and the Institute for Family Health - IFH, a network of federally-qualified health 
centers (FQHCs). Study participants will be individually randomized with randomization stratified 
by HCS, age, and gender. The primary outcome will be back-related disability, measured by the 
Roland Morris Disability Questionnaire (RMDQ) with a primary time point of 6 months. Key 
secondary outcomes include pain interference and pain intensity and back-related disability 
outcomes at 3 and 12-months. Thus, we will be able to assess the value of both a course of 
standard acupuncture (up to 15 sessions over 3 months of treatment) and of the addition of 

 
16 of 61 
Version 1.9 
 
January 2024 
maintenance acupuncture (up to 6 additional treatment sessions over months 4-6) for improving 
outcomes. We will include some pre-planned subgroup analyses to shed light on groups that 
may particularly benefit from acupuncture and those that do not. We will also conduct a cost-
effectiveness analysis of both types of acupuncture compared to UMC and a formative and 
summative analysis to help us understand important facilitators and barriers for broader scale 
implementation of acupuncture – should it prove useful.  
 
Participants will remain in the trial for 12 months and we anticipate the duration of enrollment 
and follow-up to be 29 months. We anticipate that acupuncture will be administered in outpatient 
clinics within participating HCSs and acupuncturist’s offices in the community. 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
We plan to recruit a total of 789 participants with chronic low back pain that has persisted for at 
least three months. Participants will be recruited from four health care systems: IFH (n 
=123); KPNC (n=288); KPWA (n=174) and SH (n=204). The number of participants recruited 
from each site may increase by up to 25% from these targets at IFH, KPNC, and SH and may 
increase by up to 50% from the recruitment target at KPWA with the total number not to exceed 
820 participants.  
 
 
For Aim 3, we plan to recruit and interview 10 participants from each of the four health care 
systems (n=40) that have been randomized to an acupuncture arm (SA or EA) to learn about 
their study and acupuncture experiences. We also plan to recruit, survey, and/or interview up to 
60 study acupuncturists across the four health care systems to learn about their experience 
delivering acupuncture as part of the study and more broadly in their community. We will recruit 
national stakeholders including policy experts, acupuncturists, clinicians that provide 
acupuncture, and acupuncture researchers that have a vested interest in acupuncture policy 
around treating older adults to learn more about the impact of the CMS policy for reimbursement 
for acupuncture treatment on the national landscape for acupuncture reimbursement. We will 
recruit up to 50 and interview up to 25 stakeholders. 
 
 
4.1 Inclusion Criteria 
We will require all participants to meet all the following inclusion criteria in order to participate in 
the trial.  
 
Inclusion Criteria 
Rationale and Source 
Is at least 65 years of age 
 
Age range of the Medicare older adult 
population (EHR) 
Is a current member or patient of the 
healthcare system 
A method for identifying participants who 
have current and consistent contact with the 
healthcare system (EHR and PRO) 
Visited a health care provider for low back 
pain within the past 12 months 
 
A method for identifying potential 
participants who may have cLBP (EHR) 
Received primary care at one of the 
Location of our study sites (EHR) 

 
17 of 61 
Version 1.9 
 
January 2024 
participating health care systems. 
 
Has back pain that is uncomplicated with or 
without radicular pain.  
 
This is the type of back pain we are 
studying. (EHR) 
Back pain > 3 months 
 
Meets our definition of chronic back pain 
(PRO) 
General activity question from PEG >3 
Meets minimum definition of back 
dysfunction (PRO) 
Primary care provider provides permission to 
contact patient 
 
Ensures that there is no medical or related 
reason not to include patient (via email) 
Willing and able (Callahan screener > 3) to 
provide consent 
Ethical requirement (PRO) 
 
Aim 3 inclusion criteria: In order to participate in the patient participant interviews for the Aim 3 
study activities, a participant must have been randomized to a treatment arm (SA, EA) for the 
main trial. In order to participate in the acupuncturist survey and interview, acupuncturist must 
have been eligible to treat study participants as part of the trial. We will recruit stakeholder 
participants that have a vested interest in acupuncture policy around treating older adults. 
 
4.2 Exclusion Criteria 
 
Persons who meet any of the exclusion criteria at baseline will be excluded from study 
participation.  
Exclusion Criteria 
Rationale 
Specific types of back pain (metastatic cancer 
or bone cancer or secondary cancers, 
vertebral fractures, spinal infection, active 
inflammatory disease) 
Other treatments are more appropriate than 
acupuncture for these specific causes (or 
likely causes) of LBP (EHR) 
Low back surgery within past 3 months 
May still be healing from surgery (PRO) 
Receiving workers compensation or involved in 
litigation related to cLBP 
 
Additional treatments may be required as 
there are disincentives to improve (PRO) 
Acupuncture within the last 6 months 
 
Ensures that they have not received 
acupuncture for this episode of care (PRO) 
Does not speak or write English or Spanish 
Cannot complete assessments re outcomes 
questionnaires or treatments (PRO) 
Major psychosis, dementia  
Unable to give adequately informed consent 
(EHR/provider or PRO) 

 
18 of 61 
Version 1.9 
 
January 2024 
Current cancer treatment  
Need for primary focus on cancer treatment 
(EHR) 
Red flags of serious underlying illness (a fever 
most days in the last month; recent 
unexplained weight loss of 10 lbs or more) 
Need to look for serious underlying illness to 
not delay any needed treatment for those. 
(PRO) 
Living in a nursing home, on Hospice, or 
palliative care 
Requires a different study design and 
logistics (EHR; confirm via PRO) 
Non-speaking deafness 
Cannot communicate with acupuncturists 
and study staff (EHR) 
Non-reliable transportation 
Cannot attend acupuncture treatments 
(PRO) 
 
Aim 3 exclusions criteria: Participants randomized to UMC are not eligible to participate in Aim 3 
study activities.  
 
4.3 Study Enrollment Procedures 
 
4.3.1 Participant Identification and Recruitment 
 
4.3.1.1 Recruitment Targets: We plan to recruit a total of 789 older adults from one of four 
participating HCSs. Targeted enrollment will differ by the size of the health care system as 
follows: IFH (n=123); KPNC (n=288); KPWA (n=174) and SH (n=204). The number of 
participants recruited from each site may increase by up to 25% from these targets at IFH, 
KPNC, and SH and may increase by up to 50% from the recruitment target at KPWA with the 
total number not to exceed 820 participants. We will monitor recruitment on a weekly basis and 
make adjustments on targeted enrollment between sites if we are falling behind on our targets 
at three-month intervals. We have ascertained that these HCSs had over 92,000 older adults 
who made an ambulatory care visit for LBP in the 12-month period from December 2018 to 
November 2019 and who met our electronic inclusion and exclusion criteria. With conservative 
estimates of 72% ineligible via interview (largely because of LBP not chronic or too mild) or 
primary care provider (PCP) refusal, we would still have over 25,000 patients who were likely 
eligible.  All patients who are contacted will be provided a final baseline status (unable to reach, 
ineligible – with reasons, eligible and refused, eligible and randomized). This information will be 
kept in the study database. 
 
For Aim 3, we plan to recruit and interview 10 participants from each of the four health care 
systems (n=40) that have been randomized to an acupuncture arm (SA or EA). We also plan to 
recruit up to 60 study acupuncturists for the acupuncturist surveys and interviews. We plan to 
recruit across the four health care systems to learn about their experience delivering 
acupuncture as part of the study and more broadly in their community. We plan to recruit up to 
50 and interview up to 25 national stakeholders for the stakeholder interviews.  
 
 
4.3.1.2. Identification of prospective participants and recruitment procedures 
 
We will use several methods for recruiting participants that have been successful in our 
previous studies. These include referrals from PCPs; EHR identification of potential candidates 
followed by letters or emails of invitation; and patient self-referral from direct outreach.  Each 

 
19 of 61 
Version 1.9 
 
January 2024 
site may have some slightly different variations in outreach to prospective participants and the 
basic pattern of outreach is described below.  
 
Method 1: Referral from PCPs: IFH has had good success recruiting patients for acupuncture 
research and other integrative health interventions by referrals from PCPs. In addition, we will 
explore whether PCPs at other sites might wish to refer patients and will develop relevant study 
processes to accommodate if relevant.  
 
Recruitment procedures: Dr. Ray Teets, the site PI at IFH and a PCP, will inform his 
colleagues of the study and basic requirements for enrollment. PCPs will use basic eligibility 
criteria to guide patient referral to the study; an Epic smart phrase will be developed for PCPs 
that gives a brief synopsis of the study and phone number for the clinical research coordinator 
(CRC). PCPs will share the CRC’s phone number with interested patients. In addition, PCPs will 
obtain permission from interested patient’s to be contacted by the CRC. The CRC will check the 
patient’s EHR to ensure that the patient meets basic inclusion/exclusion criteria and then send 
provisionally eligible patients an invitational letter with information about the study. The CRC will 
then call these patients referred for the study. Using a structured script, the CRC will ascertain 
continued interest in the study. If the prospective participant is interested in participating in the 
study, they will be asked to provide oral consent for screening and be administered the oral 
eligibility screener, which captures data that are not in the electronic health record (EHR). If the 
prospective participant meets the oral screening criteria and agrees to learn more about the 
study, they will be scheduled for a phone visit to have their questions answered and provide oral 
consent for the baseline and follow-up data collection, including HIPAA authorization. For study 
participants randomized to acupuncture and receiving at least one treatment, written consent for 
acupuncture treatments would be obtained at the first acupuncture visit and before treatment. 
IFH will also allow for the possibility of using method 2 (below), if recruitment via provider 
referral is not robust enough, i.e., if recruitment and enrollment targets are not being met. 
 
Method 2: Invitational letters (or emails) sent after identification of candidate participants 
using ICD-10 diagnoses from automated data: At KPNC, KPWA and SH, we will then send 
letters of invitation (KPNC, KPWA, SH) or emails of invitation via “MyChart” (SH), a HIPAA 
compliant secure web-based platform. At these participating HCSs, we expect this will be our 
primary method of recruitment.  
 
Recruitment procedures: Following approval of a HIPAA Waiver, we will use EHR data to 
identify members at least 65 years of age who have a) made a visit to a PCP in the last year for  
pain consistent with non-specific uncomplicated low back pain with or without radiculopathy, and 
b) appear to otherwise meet eligibility criteria for the study (see sections 4.1 and 4.2). Patient’s 
PCPs will be up to two weeks to remove any patients they deem inappropriate in participating 
HCSs that require or prefer such PCP review. We will then mail (or securely email) a 
recruitment packet to patients at each site who meet the EHR-derived eligibility criteria 
delineated above. The packet will include a description of the study and an informational letter 
that includes all elements of informed consent, including a clear statement of the option to opt 
out of further contact for recruitment to this study by calling the provided site-specific study 
telephone number or returning a statement of interest form and checking the box that indicates 
their desire to opt out. The invitational letter states that patients might be contacted to determine 
their interest in participating in the study if they have not called the study contact number or sent 
their return form indicating either their interest in participating or that they wish to opt-out.  
Invitational materials will include a HCS site specific telephone number patients can call to get 
more information about the study. If the prospective participant is still interested, whether they 
called in, sent in a statement of interest form or were contacted by HCS recruitment staff, oral 

 
20 of 61 
Version 1.9 
 
January 2024 
informed consent will be obtained before any screening questions are asked. For those meeting 
study screening criteria, the study staff will guide them through the consent checklist and obtain 
oral consent for the baseline and follow-up interviews as well as the electronic health record 
information needed by the study. This consent will be documented in the patient’s baseline 
study record. For some sites, mailed paper consent or electronic written consent via REDCap 
and/or Adobe sign will be obtained for the study, instead of oral consent.  
 
Method 3: Other potential outreach to target population 
We will consider augmenting study recruitment using posters and study brochures available 
throughout pertinent clinics in our participating HCSs providing a summary of the key study 
elements and inviting people to contact the study team to learn more about the study. Patients 
will be screened and, if eligible, enrolled as described in Method 1 (IFH) or Method 2 (KPNC, 
KPWA, SH) 
 
As noted, we anticipate differences in recruitment procedures between IFH (PCP in-person or 
MyChart referral) and other performance sites. In addition, there may be some slight differences 
between sites in the recruitment procedures (e.g., KPNC and SH ask that study contact PCPs 
before their patients receive an invitation for the study while the director of primary care at 
KPWA requested that the study not contact PCPs (due to burden and that acupuncture delivery 
is outside healthcare system). For KPNC and SH, the PCPs will have the option of declining to 
have specific patients contacted if the PCP believes that participating in the study would not be 
in the patient's best interest. 
 
Aim 3 recruitment procedures 
Patient participants: A study programmer will identify potentially eligible participants across the 
four health systems via BackInAction study data. We will recruit participants randomized to a 
treatment arm (SA, EA) for the main trial. Study staff will mail an invitation letter and information 
sheet to potential participants. Potential participants can call the study line to indicate that they 
are interested in participating. If study staff do not hear from potential participants within 3-5 
working days of the mailed invitation, they will call participants to follow-up and see if they are 
interested in participating in Aim 3 study activities. Study staff will make up to three call attempts 
to reach potential participants; call attempts will be spaced 2-3 working days apart.  
 
Acupuncturist participants: KPWA study staff will send the study acupuncturists a recruitment 
email with an information sheet and a survey link The email will have a brief description of the 
purpose for the survey and interview with contact information so that they may ask questions 
before continuing with the survey. Acupuncturists that complete the survey will be asked if they 
would like to participate in an interview. The study team will select a sample of acupuncturists 
that select “Yes” for the interview and invite them to complete an interview.  
 
Stakeholder participants: National stakeholders that have a vested interest in acupuncture 
policy for older adults will be identified through contacts of the study team at all study sites. 
KPWA or KPNW study staff will send stakeholders a recruitment invitation email Stakeholder 
participants will be asked to respond to the recruitment email or follow a link to complete a short 
REDCap interest survey if they are interested in participating in a study interview.  
 
 
4.3.2. Eligibility screening and consent procedures 
 

 
21 of 61 
Version 1.9 
 
January 2024 
Study staff will ask for verbal consent for the oral eligibility screen, which will be done by 
telephone. The status of all participants will be collected, including reasons for oral ineligibility 
(e.g., back pain not > 3 months, activity limitation too mild, etc.). If oral consent and HIPAA 
authorization is permitted at some sites, we will then go over the elements of informed consent 
in the telephone interview, answering any questions that the patient has and documenting oral 
consent in the database. Otherwise, we will obtain electronic written consent as described 
above. Finally, if that is difficult, we will send written consent forms to patients to sign before 
proceeding with the baseline interview and randomization.  
 
Aim 3 research activities 
Patient Participants: Study staff will obtain oral consent from participants for the Aim 3 phone 
interviews and document it in REDCap. Study staff will discuss the phone interview with 
participants using a recruitment phone script. The script includes a thorough description of the 
research activities and gives the participant the chance to ask questions regarding the 
interviews. In addition, the script contains clear language that participation in the interviews is 
voluntary and will in no way impact the rights of the participant, their access to care at their 
health care institution, or impact their participation in the main trial. Study staff will also confirm 
participant’s permission to participate in and record the interview before starting the phone 
interview. 
 
Acupuncturist participants: KPWA study staff will send the study acupuncturists a recruitment 
email with an information sheet attached and the survey link embedded at the end of the email. 
The email will have a brief description of the purpose for the survey and interview with contact 
information so that they may ask questions before continuing with the survey. Acupuncturists 
will be given the opportunity and encouraged to ask questions via email or by phone to the 
study PM sending the recruitment email. The information sheet provides information about their 
rights and protections as participants, and additional detail regarding the purpose of the study.  
Acupuncturists will give consent to participate in the Aim 3 acupuncturist survey in the REDCap 
form and verbal consent for the interview. Consent for both the survey and interview will be 
documented in REDCap by study staff. Acupuncturists that complete the survey will be asked 
on the survey form to indicate that they have read the information sheet and that they asked 
questions if needed by selecting a “Yes” or “No” response at the beginning of the survey in 
REDCap. On the survey form, the project manager’s (PM’s) contact information will again be 
made available for the acupuncturist to ask questions prior to answering questions on the 
survey. The study team will select a sample of acupuncturists that select “Yes” for the interview 
and invite them to complete an interview.  
Phone interviews will be recorded by the study team via Teams or with an audio recording 
device. The recording will begin after the interviewer briefly reviews the information sheet with 
the acupuncturist to check whether they have any questions, and after the acupuncturist gives 
verbal consent to participate in the interview and be recorded. The KPWHRI staff performing the 
interview will take notes and will document in REDCap whether the acupuncturist participant 
gave verbal consent to both participate and record the interview. 
 
Stakeholder participants: KPWA or KPNW study staff will send stakeholders a recruitment 
invitation email with an information sheet attached that provides information about the study 
procedures, potential risks and benefits, voluntary participation, confidentiality, and the option to 
withdraw at any time. Stakeholder participants will be given the opportunity and encouraged to 
ask questions via email or by phone to the study staff sending the recruitment email. 
Stakeholder participants will be asked to respond to the recruitment email or follow a link to 
complete a short REDCap interest survey if they are interested in participating in a study 

 
22 of 61 
Version 1.9 
 
January 2024 
interview. Prior to beginning the recording, stakeholders will give verbal consent for the 
interview.  
Phone interviews will be recorded by the study team via Teams or with an audio recording 
device. The recording will begin after the interviewer briefly reviews the information sheet with 
the participant to check whether they have any questions and after the participant gives verbal 
consent to participate in the interview. The participant will be asked to give verbal consent to be 
recorded. While the participant must give verbal consent to participate in the interview, they do 
not need to consent to be recorded. If the individual consents to the interview but not to be 
recorded, the interviewer will take notes to capture as much of the interviewee’s responses as 
possible. The KPWHRI or KPNW staff performing the interview will take notes and will 
document in REDCap whether the stakeholder participant gave verbal consent to both 
participate and record the interview.  
 
4.3.4. Randomization  
 
One of our study biostatisticians will prepare the randomization scheme for each site using a 
generic code of Arm 1, 2, 3. The unmasked database programmer can then assign a code to 
each of the study arms so that the biostatisticians remain blinded to treatment group. The 
randomization scheme will be embedded in the computer program at the end of the baseline 
interview. It will include stratified blocked randomization based on site, age group (65-74; 75-84; 
85+), and sex. Block sizes will be randomly varied. The study interviewer will press a button and 
the appropriate group assignment will appear. (In order to mask the follow-up interviewer to 
participants’ group assignments, a different interviewer will administer those interviews. This has 
worked well in our previous trials25,41). Patients randomized to EA will be informed whether or 
not they were selected to receive additional maintenance treatment sessions close to the end of 
the first 3 months of treatment (approximately 10 weeks into the study) so that their treatment is 
unlikely to be altered by the knowledge of additional visits. In addition, acupuncturists will be 
masked to SA or EA group assignment until 10 weeks into the SA period so that they don’t 
provide different treatments in the standard treatment group based on whether the participant 
has a maintenance period or not.  
 
4.3.5 Assignment to Acupuncture 
 
At KPNC, KPWA and SH, participants who are randomized to acupuncture will be provided with 
the names of those acupuncture providers who have experience treating chronic low back pain 
and working with older adults, have agreed to see study patients, and who are conveniently 
located for patients. Patients will then select an acupuncturist from those listed as study 
affiliated and the study will fax a study referral to the acupuncturist with the patient information. 
Minor variations such as scheduling the first visit online for the patient or calling the acupuncture 
office with the patient on the call will be permitted. At IFH, acupuncture is provided onsite and 
patients will be scheduled on site.  
 
4.3.6. Screening and Consent Procedures 
 
These are described in section 6.2.1. 
 
5. STUDY INTERVENTIONS  
 
5.1 Interventions, Administration, and Duration  
 

 
23 of 61 
Version 1.9 
 
January 2024 
Acupuncture will be individually administered to patients by a licensed acupuncture practitioner 
in outpatient HCSs clinics or community acupuncturists’ offices.  
 
5.1.1. Standard acupuncture (SA): 
 
Our SA intervention is based on classical Chinese acupuncture therapy and was developed with 
a team of experts using a modified Delphi process. It involves up to 15 acupuncture treatments 
over 3 months with the total number being determined by the patient and acupuncturist 
together. (Fifteen treatments is consistent with the greatest number of allowed treatments in 
some of the largest acupuncture trials to date.28-30) We encourage, however, a minimum of 6-8 
treatments in the first 8 weeks,23,42 with at least 1-2 treatments in the last 4 weeks.24,25 The 
Acupuncture Advisory Panel recommended that we consider 8 treatments as the minimum for 
determining if the patient is not a responder to acupuncture. Treatment visits will typically last 
45-60 minutes. All treatments will include only acupuncture needling, even though other 
adjunctive modalities (e.g., moxibustion or other forms of heat, cupping, gua sha, tui na) are 
typically part of practice.43 Treatments will be provided at medical facilities or in private 
acupuncturists’ offices. 
 
Our general approach is classical Chinese acupuncture that includes palpation of the channels 
and acupoints. We used a modified Delphi process to refine our planned acupuncture 
intervention over three phone meetings and an additional round of email. Acupuncture Advisory 
Panel (AAP) members included nine members: expert physician and licensed acupuncturists 
representing diverse backgrounds (e.g., work with underserved populations, university clinics, 
work inside of health plans, medical director of a holistic medicine network, academic dean at 
an acupuncture college) and an acupuncture researcher who has numerous publications on 
acupuncture treatments for cLBP. We provided the AAP with data on acupuncture interventions 
from well-designed trials of acupuncture for cLBP,25,26,29,31,44-52 how a group of experienced 
China trained practitioners report treating older adults with cLBP53 and how each of the group 
members described how they would treat older adults with cLBP (from a survey). We used the 
STRICTA checklist54 for reporting acupuncture trials as a guide for organizing our discussions 
and plan to capture the information necessary to report the treatment provided in the trial 
according to the STRICTA checklist. 
  
Acupuncturists are expected to begin each visit with the intake questions (aka “asking” 
interview) and follow with other assessments (range of motion observation, palpation of the 
region, channels and Hara). This will be followed by point selection and needling (with the 
characteristic de qi at practitioner discretion); needle retention; removal of needles and resting 
or optionally, changing position to treat another part of the body, further palpation and point 
selection and needling (de qi at practitioner discretion); needle retention, removal of needles, 
and resting. Acupuncturists are expected to check in with patients at the end of the session, 
assessing pain and range of motion and a patient’s readiness to leave the treatment room, 
provide any self-care recommendations, and confirm the next appointment. We expect 
treatment sessions to include both local and distal acupoints55 and that specific point 
combinations will vary between treatment sessions and per patient. We recommend non-coated 
needles and will capture data on typical needle characteristics (gauge, length).   
 
Through the Delphi process, our Acupuncture Advisory Panel recommended including a total of 
113 named acupoints (214 acupoints total if counting bilaterally): low back acupoints (29; 58 if 
bilateral; 4 central for total of 62), acupoints on the mid and upper back (33; 66 if bilateral; 2 
central for total of 68), front of the body including distal leg acupoints (33; 66 if bilateral; 6 
central points for total of 72) and ear acupoints (6; 12 if bilateral).These are shown in Appendix 

 
24 of 61 
Version 1.9 
 
January 2024 
1. Ashi points (tender upon palpation) are also permitted. Other acupoints can be selected if 
additional rationale is provided. We anticipate 6 to 20 needle insertion sites will be used in each 
treatment, although the first may involve fewer needles. If patients are treated in one body 
position, needle retention time is typically 20-30 (up to 40) minutes. If patients are treated in two 
body positions, needle retention time is typically 15-20 (up to 25) minutes.  
 
5.1.2. Enhanced Acupuncture (EA): 
 
The EA intervention includes the 3 months of standard acupuncture plus an additional 3 months 
of maintenance acupuncture, which can include up to 6 treatments to be spaced at least every 
other week (tapered). The maintenance acupuncture treatment sessions are expected to consist 
of the same intervention used in the first 3 months of care described above.  
 
We are unaware of any trials of acupuncture for cLBP that have evaluated the use of 
maintenance acupuncture, even though acupuncturists often recommend maintenance visits 
after a course of more intensive treatment. Berman and colleagues56 conducted one of the few 
studies that included a gradually tapering protocol as part of a knee osteoarthritis trial. In that 
study, treatments decreased from twice weekly to weekly to every other week to monthly. Based 
on discussions with our AAP, we propose allowing up to 6 treatments during the 3-month 
maintenance phase. 
 
Integration of Acupuncture into Care and Study Acupuncturists: Each of our participating HCSs 
has a distinct way of providing general acupuncture services for adults. The most common 
practice in our HCSs and nationally is to refer patients to acupuncturists practicing in the 
community and we will use this process for many of our study visits. At IFH, acupuncture will be 
provided in the FQHC primary care clinics. Acupuncture will be provided in individual treatment 
sessions in all locations.  
 
Acupuncturists will have at least five years of experience working at least 50% of the time in 
patient care. There may be exceptions for 3 years’ experience per individual applicant, for 
example with other health care licensure. They will need to be state licensed, malpractice 
insured (with no current or historic malpractice claims) and experienced in treating patients with 
chronic low back pain and who have multi-morbidities. They will also need to be experienced 
working with older adults. In addition to the above, they will be vetted by the health plans and/or 
lead acupuncturist (for example, at KPWA, we will recruit from our network of providers and at 
IFH, we will recruit from prior trials).They will all be trained in the protection of Human Subjects 
for research, as well as the study protocol, special safety issues for our study, and the logistics 
of delivering and recording study treatments. They will be certified for participation in the study.  
 
Capturing acupuncture treatment visit information:  
 
As a pragmatic trial, patients are not required to complete all acupuncture visits to stay in the 
study. An intent-to-treat approach to analysis will be used. Data for each visit at KPNC, KPWA 
and SH will be collected from the treating acupuncturist in a secure, SQL server HIPAA-
compliant online database, which in turn will trigger a payment to the acupuncturist for the 
acupuncture session. Acupuncturists working at IFH clinics will chart in the EHR using a 
specially designed EPIC template. Data will be securely submitted following each session with 
the following information: date, visit number, visit length, visit disposition (e.g., completed, 
cancelled, no show), elements of the visit (e.g., asking interview, palpation of acupoints), 
selected needling details (e.g., number of needles, retention time, acupoints needled,  whether 
this was this the last recommended treatment), and patient reported adverse events. Based on 

 
25 of 61 
Version 1.9 
 
January 2024 
ours and others previous studies25,32,34, we expect that patient reported AEs are most likely to 
involve minor pain, dizziness, itching or bruising after needling, transitory exacerbation of pain, 
or fatigue.  
 
The collected information will allow us to fully characterize acupuncture treatment practices and 
may provide important information for secondary exploratory analyses examining patient 
responsiveness to treatment. We have developed and used similar treatment visit forms for 
other studies,57-59 and have worked with our acupuncture advisory group during the UG3 year to 
refine these data collection forms and processes for the study. Minor changes were made after 
the pilot studies were completed. A copy of the acupuncture visit form is shown in Appendix 2.  
 
Trial acupuncturists’ fidelity to agreed upon practice parameters will be routinely and 
systematically assessed via their completion of the online, standardized study forms for each 
treatment session.  
 
Any acupuncture care participants may seek independent of the study would be subject to usual 
care billing and documentation. However, no patients nor patient insurance policies will be billed 
for study-related visits, as consistent with other pragmatic trials conducted in the participating 
health systems. 
 
5.2 
Handling of Study Interventions  
 
Acupuncture sessions will be delivered in the clinics of the participating HCSs or in the private 
offices of acupuncturists in the community. All treatments will be charted electronically.  
 
5.3 
Concomitant Interventions  
 
5.3.1 Allowed Interventions 
 
Participants in all groups will be able to access all treatments available to them as part of their 
insured health care offerings as well as anything they wish to pay for out of pocket.  
 
5.3.3 Prohibited Interventions 
 
We will also ask study acupuncturists to avoid using specific modalities of treatment that are 
often used in Chinese medicine as adjuncts to needling such as moxibustion, cupping, and gua 
sha. We will ask participants in the usual care group to avoid acupuncture over the course of the 
study. 
  
5.4 
Assessment of Adherence 
 
Adherence will be defined for both the standard acupuncture and the maintenance phases of 
the intervention. For the standard acupuncture period, an adherent participant will be 
characterized as one who receives at least 8 treatments (but not more than 15) and the 
acupuncturist indicates that treatment is complete or the participant receives at least 12 
treatments (80% of the 15 potential treatments). For the maintenance acupuncture phase, 
adherent participants will be characterized as those who receive at least 4 treatments (and not 
more than 6) or for whom the acupuncturist indicates that the treatment is completed. 
Participants in the EA group who have, according to the acupuncturist, completed treatment in 
the standard period will still be expected to attend maintenance acupuncture sessions. 

 
26 of 61 
Version 1.9 
 
January 2024 
Allowable ranges of adherent treatment have been characterized because we expect that the 
number of treatment sessions in standard or maintenance acupuncture will vary between 
patients. Participants in the EA group whose acupuncturist stated that treatment was complete 
in the first 3 months (standard period) will still be asked to attend maintenance treatments 
because that tests the value of the maintenance period for long-term benefits on study 
outcomes.  
 
We will assess adherence by several means: attendance at acupuncture visits and the content 
of those visits. Because different participants might require different numbers of visits, we will 
ask the acupuncturists at each visit to let us know whether the patient is continuing treatment, 
has completed treatment or is unlikely to improve (including before and after at least 8 
treatments as recommended by the Acupuncture Advisory Panel). This will allow us to 
determine whether a patient stops treatment prematurely. Even patients who stop the treatment 
prematurely in the standard treatment period but are randomized to receive maintenance 
acupuncture will be encouraged to make acupuncture visits in the maintenance period.  
We will assess acupuncturists’ fidelity to the treatment protocol by reviewing completed 
treatment forms at the end of each treatment session, which will include key details of their 
study visit, the structure of the visit, needling details and acupuncture points used, visit duration, 
and self-care recommendations (Appendix 2 has a copy of the form). We will also ask patients 
about their use of non-study acupuncture treatments to characterize any acupuncture received 
by participants outside study provided services.  
6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations  
 
Assessment 
EHR 
screen 
Phone 
screen 
Baseline 
Phone 
Survey 
Acupuncture 
Visits 
Monthly 
3,6, 12 
Months 
Eligibility 
 
 
 
 
 
 
Informed Consent  
 
± 
* 
 
 
Demographic 
Information 
 
 
 
 
 
 
Baseline 
Questionnaire 
 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
Monthly Short 
Questionnaire 
 
 
 
 
 
 
Follow-up 
Questionnaire 
 
 
 
 
 
 
Adverse events 
 
 
 
 
 
 
± All aspects of the study will be discussed via phone and prospective participants will be 
provided with consent checklists. IFH and SH plan to obtain electronic written consent for the 
study; KPNC and KPWA plan to obtain oral consent for the study interviews and electronic data 
extraction. 

 
27 of 61 
Version 1.9 
 
January 2024 
* IFH, KPNC and KPWA will also get written or electronic consent for acupuncture treatments 
before the first treatment. 
 
6.2  Description of Evaluations  
 
A waiver of consent will be obtained to use electronic health records to pre-screen patients 
according to the eligibility criteria that can be ascertained via those records. We will have ICD-
10 codes and contact information, including name, address and phone number. 
.  
6.2.1 Screening Evaluation 
 
At all sites, the screening evaluation will be done by telephone after obtaining oral consent for 
screening. If the patient is interested and eligible, we will conduct a second consent process that 
further explains the study and answers questions. 
 
Consenting Procedure 
 
If the sIRB permits it (for each HCS where the IRB administrator is in agreement), we plan to 
obtain oral consent (waived written consent) from prospective participants for participation in the 
baseline and follow-up interviews. (If required by the local IRB, we will obtain written consent). 
We would then obtain written consent for acupuncture treatment from any participant who is 
randomized to either SA or EA and makes at least one visit to the acupuncturist. A study 
interviewer will administer oral consent to prospective participants, ensure full understanding of 
study focus and procedures, and answer any questions. The oral consent process will describe 
the purpose of the study, the procedures to be followed, the risks and benefits of participation 
and how participants’ data will be handled. This information will also have been provided in a 
study information sheet sent with the initial study invitation letter and  will include questions 
related to acupuncture. Thus, participants who are randomized to acupuncture will sign a 
consent form that contains information they already reviewed with the study interviewer before 
they receive treatment. For some participants, this will be similar to consent for treatment 
documents they have signed for treatment as part of their regular medical care. Acupuncture 
consent forms will be sent by the acupuncturist to each HCS for storage in locked filing 
cabinets, At IFH, the participant signed consent to acupuncture clinical treatment form, which is 
not a research document, will be stored in the participants’ EHR.  
 
For sites that permit oral consent (waived written consent), a study interviewer will administer 
oral consent to prospective participants, ensure full understanding of study focus and 
procedures, and answer any questions. The oral consent process will describe the purpose of 
the study, the procedures to be followed, the risks and benefits of participation and how 
participants’ data will be handled. This information will also have been provided in a study 
information sheet provided to the participant previously.  
 
Participants will be told that they are free to not respond (by web or phone) or to terminate 
involvement at any time, with no adverse consequences.  If a participant appears to be 
distressed during assessments, research staff will halt the interview and offer to call back to 
complete the interview. The interview will only recommence when and if the participant reports 
feeling capable of doing so.  The interviews during the study involve no specific risk or 
discomfort beyond those of a standard clinical interview. Interviews will be conducted by 
experienced and well-trained staff sensitive to these issues.   
 

 
28 of 61 
Version 1.9 
 
January 2024 
Screening 
 
The screening process will typically occur on the same day as randomization (for oral consent 
for the trial). For patients who are required to have electronic written consent, we will aim to 
obtain that within one week of screening or administer the back pain eligibility questions again 
when written consent is obtained more than 30 days after screening. Participants will be asked 
a series of questions that should determine their eligibility (back pain duration, activity limitations 
due to back pain, capacity to provide consent, recent low back surgery, receiving workers 
compensations for cLBP or litigation related to cLBP, acupuncture within last 6 months, does 
not speak or write English or Spanish, unexplained weight loss of 10 lbs or more, fever; see 
Section 4.1 and 4.2 for more detail). Any of the questions can make them ineligible.  
 
6.2.2 Enrollment, Baseline, and/or Randomization 
 
Enrollment 
 
Enrollment in the study occurs when an individual is screened eligible, has provided oral (if 
allowed) or written consent, has completed the baseline assessment questionnaire and has 
been randomized to a treatment. This should be within a month of eligibility assessment.  
 
Baseline Assessment and Outcomes 
 
Study Measures and Schedule of Administration 
DOMAINS 
Baseline 
Monthly 
Follow-
up 
3-, 6- and 12-
Month 
Follow-up 
Data Source 
Demographic and Clinical Characteristics 
Patient Characteristics 
 
  
  
EHR & PRO 
Medical and Back Pain History 
 
  
  
EHR & PRO 
Expectations of Acupuncture  
 
  
  
PRO 
Abbreviated COVID questions 
 
 
 
PRO 
Primary, Secondary and Tertiary Measures 
* Back-related dysfunction (RMDQ) 
 
  
 
PRO 
PEG [CDE] 
 
 
 
PRO 
Physical Function [CDE] 
 
 
 
PRO 
PHQ-4 [Anxiety/Depression] [CDE] 
 
 
 
PRO 
Sleep Disturbance [CDE] 
 
  
± 
PRO 
Patient Global Impression of Change [pain][CDE] 
  
  
 
PRO 
Fatigue  
 
  
 
PRO 
Ability to Participate in Social Roles and Activities  
 
  
 
PRO 
Patient Global Impression of Change [overall 
status] 
  
  
 
PRO 
High Impact chronic pain [CDE] 
 
 
± 
PRO 
Euro-QOL-5D 
 
  
 
PRO 
Treatment-Related Information 

 
29 of 61 
Version 1.9 
 
January 2024 
Adverse Events 
  
  
# 
PRO; EHR; 
Treatment 
Records 
Use of acupuncture during study period 
 
 
^ 
PRO 
Adherence to Assigned Treatment  
  
  
 
Treatment 
Records 
Health Care Utilization 
Health Care Utilization and Costs  
 
  
 
EHR; Medicare 
Fee Schedule; 
PRO 
Pain-related Health Services, Products & Self-
Management Practices 
 
 
 
PRO 
Daily Exercise and Job-related Activity 
 
 
 
PRO 
 
 
 
Other HEAL Common Data Elements (CDE) 
 
 
 
 
 
 
 
 
 
 
Pain Catastrophizing Questionnaire (6-item) 
 
 
± 
PRO 
Substance Use (TAPS) 
 
 
^ 
PRO 
*Primary Outcome Measure (Roland Morris Disability Questionnaire) 
Blue measures are recommended by the NIH Task Force 
(RTF) 
 
**CDE=HEAL Common Data Elements (required for all HEAL trials) 
PROMIS-29 profile V 2.0, note we will add 2 additional questions to the Physical Function and Sleep 
Disturbance Measures to ensure measures in these domains reflect core HEAL measures. We will not 
be asking the Pain Intensity, Pain Interference, Depression or Anxiety Scales 
± At 6-month timepoint only (Sleep duration is asked at all timepoints.) 
#At 3- and 6-month timepoints only 
^At 12-month timepoint only 
Our approach to measurement includes adoption of many recommendations by the NIH 
Research Task Force for Low Back Pain (RTF),60 the IMMPACT domains for clinical trials of 
chronic pain61 and the NIH PRISM HEAL Common Data Elements (CDE). In addition, we plan 
to harmonize as much as possible with the Optimum trial, which is also a study focused on 
cLBP. In considering measures to include in our assessment battery, we attempted to adopt as 
many of the HEAL CDE as we reasonably could while ensuring that constructs pertinent for our 
study target population were included and that redundancy and potential cognitive load was 
minimized to reduce burden on our older adult population.   
 
Baseline Interview 
When possible, we will obtain sociodemographic characteristics from the EHR including: 
birthdate (to calculate age), sex, race, and ethnicity but will verify this information at the baseline 
assessment as well as augment it with the “sex at birth” and “gender identity” questions from the 
HEAL Common Data Elements (CDE). Other sociodemographic variables will be obtained 
directly from the participant including: employment status, education, marital status, income, 
tobacco use, alcohol use, duration of pain condition. Further questions characterizing the 

 
30 of 61 
Version 1.9 
 
January 2024 
participant’s current pain condition (presence of sciatica), potential prognostic risk for pain-
related impairment (e.g., pain catastrophizing, fear avoidance, treatment expectations, and 
disability/workers compensation), and pain-related service use (e.g., back surgery, injections, 
opioid and other common prescription medications, various types of exercise, psychological 
counseling, and use of acupuncture) align with RTF recommendations or are specific to the 
study’s focus on acupuncture. We will measure patient expectations of acupuncture using one 
item from the EXPECT short form62 and using the term acupuncture as the therapy. The 
question uses a 0 to 10 scale focused on expectations related to acupuncture treatment for 
chronic low back pain. We will include questions about the impact of the COVID-19 pandemic 
on the ability to get health care and on their overall health (physical, emotional, and mental, 
including pain). These were adapted from a patient questionnaire developed by the Pain 
Management Collaboratory funded by the NIH – Department of Defense and Veterans 
Administration63. We will ask several questions from the FRAIL scale to characterize participant 
frailty at the time of enrollment in this study. Finally, we will also collect data from the EHR on 
other co-morbidities, including various pain conditions. This will allow us to describe the 
population as well as conduct some moderator analyses.  
 
Aim 1 measures (Baseline AND 3, 6 and 12-monthfollow-up).  
 
Back-related disability will be measured with the 24-item Roland-Morris Disability Questionnaire 
(RMDQ),64 which asked whether 24 specific activities were limited due to back pain during the 
past week (yes or no). This legacy measure has been found to be reliable, valid and sensitive to 
clinical changes.65-69 It is appropriate for telephone administration for patients with moderate 
disability.70  The RMDQ will be our primary outcome measure and will be measured as a 
continuous variable. The minimal clinically important difference (MCID) for the RMDQ in our 
population is 2 points71 or 30% improvement from baseline.72 The MCID will be examined in a 
secondary analysis.  
 
As a secondary outcome measure and a HEAL CDE, we will use the PEG scale (a validated, 3-item 
pain-intensity and pain-related interference composite measure assessing Pain intensity, as well as 
pain interference with Enjoyment of Life and General Activity.75  
 
The PROMIS®, the Patient-Reported Outcomes Measurement Information System, was 
developed as a set of patient reported outcomes that can assess physical, mental and social 
health in adults and children.76,77 In this study, we propose to use four domains of the PROMIS®-
29, which has eight outcome domains important for a study of cLBP in older adults. These 
include physical function, sleep disturbance, fatigue and ability to participate in social roles. All 
short-form measures we will use are 4-items except for Physical Function. The RTF 
recommends the use of pain intensity, pain interference, physical function, depression, anxiety, 
and sleep disturbance, all domains covered by the PROMIS®-29.60 Deyo et al.78 found that the 
PROMIS®-29 measures had good to excellent internal consistency and worse scores among 
older patients with chronic pain associated with falls, high catastrophizing and worker’s 
compensation, suggesting its value for use with older adults. Hence, we believe the PROMIS 
measures are best suited for use with our older adult population. However, in the interest of 
adopting all the required HEAL CDEs, we will add 2-items to the physical function and sleep 
disturbance questions so that they are the 6-item HEAL core recommended versions of these 
scales, and substitute the PHQ-4 anxiety depression screener rather than use the PROMIS® 
anxiety and depression scales. All versions of the multi-item short-forms we are using include 
the range of mild to severe impairment for that domain and measure at least 3 standard 
deviations of the T-scores80, the healthy population plus roughly two standard deviations of the 
unhealthy population.81 Correlations between each multi-item short form we are using and the 

 
31 of 61 
Version 1.9 
 
January 2024 
full-item bank are above 0.9 for all domains except physical function, where the correlation is 
roughly 0.87.80 Power for detecting a small (0.2) effect in a clinical population for each multi-item 
measure with our sample sizes is well over 90%.80 Construct validity was demonstrated for 
these measures as well.80 Below, we describe other features of the individual PROMIS® short 
form measures we are using.  
 
 
Physical Function will be measured by the 6-item PROMIS® physical function measure. It has 
been found to perform well psychometrically compared to the RMDQ.84 It is a secondary 
outcome. 
 
Sleep quality will be measured by the 6-item PROMIS® Sleep Disturbance Scale. In a study of 
community-dwelling older adults,85 the unidimensional measure was found to have acceptable 
internal consistency and strong construct validity. It is a tertiary outcome and is asked about at 
baseline and 6-months. We will ask about sleep duration at baseline and all follow-up 
timepoints. 
 
Depression will be measured by two items from the PHQ-486, which are recommended as a 
screen for depressive symptoms87 . Use of this measure will allow us to harmonize with the 
HEAL CDE. It is a tertiary outcome.  
 
Anxiety, which is a tertiary outcome, will be measured with two items of the  PHQ-4.86 that   
include two core anxiety items from the GAD-788 and will allow calculation of the GAD-2 score. 
This will allow us to harmonize with the HEAL CDE for anxiety.  
 
Fatigue will be measured by the 4-item PROMIS® Fatigue Scale and will be a tertiary outcome. 
This is of interest because acupuncture can address fatigue and it is a reported concern for 
many older adults.  
 
We will assess the ability to engage in social roles using the 4-item PROMIS® Ability to 
Participate in Social Roles subscale, which is also pertinent to older adults because of the 
importance of social interactions to combat loneliness. This will be a tertiary outcome.  
 
We will also ask two questions about high impact chronic pain (one question is about the number of 
days of pain in the last 3 months and the number of days with limited activities due to pain in 3 
months. Using these plus the PEG, we will be able to classify people in our trial into 3 groups: High 
impact chronic pain (in the last 3 months, both pain on most or every day and limited activities due 
to pain most or every day); bothersome chronic pain ( in the last 3 months, pain on most or every 
day and never or some days with activity limitation due to pain as well as PEG score of 12 or 
higher); mild chronic pain (in the last 3 months, pain on most or every day and never or some days 
with activity limitation due to pain as well as PEG score of less than 12).89  
 
Aim 2 measures:  
 
Measures of both costs and effectiveness are needed for cost-effectiveness analysis. We will 
use the EQ-5D, one of the most commonly used measures of generic health status, to generate 
our measures of effectiveness. It measures five dimensions of health status (mobility, self-care, 
usual activities, pain and discomfort, anxiety and depression) and has five levels for each of 
these (having no problems to having extreme problems). Scores on each of these dimensions 
are then weighted using US population preference weights90 to generate a time point-specific 

 
32 of 61 
Version 1.9 
 
January 2024 
measure of health-related quality of life or utility. These utility values across the study period are 
used to calculate quality-adjusted life-years (QALYs), a generic measure of health improvement.  
 
We will be calculating cost-effectiveness from both a health care sector and a Medicare 
perspective. The health care sector perspective includes all “formal health care sector (medical) 
costs borne by third-party payers.”91 The Medicare perspective includes all costs Medicare 
would likely reimburse. Because there is no efficient and timely way to capture non-Medicare-
reimbursed costs for the SH and IFH health systems, we will only calculate the health care 
sector perspective for participants in the Kaiser systems. Measures of health care utilization 
within the health care system (provider visits, imaging studies, prescription medications, costs) 
will be captured from the electronic health record and/or from Medicare claims data. We will 
identify and separately include back pain-related costs in our analyses. The use of acupuncture 
sessions will be captured from study records.  
 
Aim 3 qualitative data collection: 
 
The qualitative work on this study focuses on both formative and summative evaluation 
questions92 The evaluation will use the RE-AIM (reach, effectiveness, adoption, implementation, 
maintenance) model.94,95. After the clinical trial is well underway (UH3 year 2), we will conduct 
interviews  and/or virtual focus groups with patients (and potentially with acupuncturists) who 
have participated in the trial to get input on the implementation of the acupuncture interventions 
and document the experiences of participating patients (and potentially acupuncturists). 
Feedback from study acupuncturists may also be solicited through surveys.  
 
The RE-AIM guided evaluation work94,95  will be initiated in UH3 Year 2. This model has four 
components: Reach, Effectiveness, Adoption, Implementation, and Maintenance. Reach 
reflects the percentage and characteristics of persons who receive the intervention. We will use 
EHR and assessment data to document: 1) the percentage of patients excluded from the trial 
and the rationale for exclusion, and 2) the percentage of patients receiving acupuncture based 
on the denominator of all patients approached for participation, as well as all potentially eligible 
patients in each health plan regardless of whether or not they were approached for study 
participation. Effectiveness measures the impact of the intervention on important study 
outcomes (see Study Measures and Schedule of Administration). Qualitative data can be critical 
for a richer understanding of quantitative study findings (reach, recruitment and effectiveness). 
HCS Adoption is less relevant for this study as many acupuncture services will be provided 
outside the HCS clinics (as is standard in these settings). However, there may be valuable 
lessons to be learned from those sites that choose to offer acupuncture within the HCS clinics 
(IFH and others) and by tracking relevant organizational and policy changes.  Furthermore, 
adoption may be influenced by patient experiences, which will be ascertained through interviews 
and/or focus groups conducted with patients (and, potentially, acupuncturists). Finally, 
Maintenance (the ability to sustain acupuncture services in these and broader health care 
settings), will be assessed through qualitative interviews, survey, and/or focus groups with 
patients, and/or survey data collection and qualitative interviews with study acupuncturists and, 
other stakeholders. Interviews with acupuncturists will focus on barriers and facilitators to 
providing acupuncture under the study and CMS guidelines for reimbursement for acupuncture 
services for Medicare patients. Stakeholder interviews  will focus on understanding factors 
important for clinical and operational leaders in including provisions for acupuncture treatment in 
their settings and the way that the CMS policy for reimbursement has affected the ability to 
provide services to older adults. Further, our acupuncture advisory group can provide input into 

 
33 of 61 
Version 1.9 
 
January 2024 
important factors for offering acupuncture treatment in a variety of settings (including fee for 
service). 
 
Patient Participant Interviews 
Interviews will be conducted by telephone; patient focus groups will be conducted virtually in 
real-time using a telephone/video conferencing platform such as Teams.  
If a participant is interested in participating in the Aim 3 phone interviews, study staff will 
schedule a 60-minute phone interview for the participant with the qualitative interview team and 
email or mail the participant a confirmation letter. Study staff will send an email reminder and/or 
place a reminder call to participants 1-2 days before their scheduled interview day/time. Phone 
interviews will be recorded by the study team via Teams or with an audio recording device. The 
recording will begin after all preliminary information has been reviewed and after the participant 
gives verbal consent to record and participate in the interview. After the recording has started, 
the participant will confirm their consent to participating in the interview and the recording of the 
interview. The recording will be sent to a professional transcriptionist (Jackson Street 
Associates), with whom we have a Business Associate Agreement established, via secure file 
transfer to be transcribed. Interview transcripts will be returned to the study team via secure file 
transfer and stored in a secure project folder on the KP Washington network. Only BackInAction 
study staff will have access to the transcripts and will remove any identifiable information from 
the final transcripts. The audio files will be destroyed 5 years after the conclusion of the project. 
Study staff will add $50 to a participant’s ClinCard for completing the phone interview. 
 
Acupuncturist Interviews & Survey 
BIA acupuncturists will be invited to complete a survey (hosted on REDCap) and interview. 
Interviews will be conducted by telephone or Teams call.  
If an acupuncturist is interested, they will be asked to complete a survey, estimated to take up to 
30 minutes to complete. The acupuncturists will receive an invitation via email with a link to the 
REDCap survey. The recruitment email provides a clear explanation of the purpose of this 
survey and interview, as well as it being optional, and encourages them to ask the KPWHRI 
staff questions if they have any. Acupuncturists that complete the survey will be asked to 
indicate that they have read the information sheet and asked questions (if needed) by selecting 
a “Yes” or “No” response at the beginning of the survey in REDCap. The project manager’s 
(PM’s) contact information will be made available to request clarifications prior to answering 
questions on the survey. KPWHRI BIA study staff will document acknowledgement of 
acupuncturist consent as part of the survey in REDCap, which is for both the survey and the 
interview (if they indicate interest and are selected for interviewing). 
If the acupuncturist selected “Yes” in the REDCap survey to participate in the phone interview, 
they will be invited to participate in a phone/Teams voice call interview with study staff, 
estimated to last up to 60-minutes. Phone interviews will be recorded by the study team via 
Teams or with an audio recording device. The recording will begin after the interviewer briefly 
reviews the information sheet with the acupuncturist to respond to any questions, and after the 
acupuncturist gives verbal consent to participate in the interview and be recorded. The KPWHRI 
staff performing the interview will take notes and will make a note in the REDCap database 
indicating whether the participant gave verbal consent to both participate and record the 
interview. 
The recording will be transcribed automatically by Teams and then reviewed by study team 
members.  Transcripts will be stored in a secure project folder on the KP Washington network. 
Only BackInAction study staff will have access to the transcripts and will remove any identifiable 

 
34 of 61 
Version 1.9 
 
January 2024 
information from the final transcripts. The audio files will be destroyed 5 years after the 
conclusion of the project.  
Study staff will send an incentive of $25 after completion of the survey, and those that complete 
the interview will receive an additional $50.  
 
Stakeholder Interviews 
Stakeholder participants will be invited for a 30-45 minute interview. Phone interviews will be 
recorded via Teams. The recording will begin after the interviewer briefly reviews the information 
sheet with the stakeholder participant to respond to any questions, and after the participant 
gives verbal consent to participate in the interview and be recorded (if the individual consents to 
the interview but not to be recorded, the interviewer will take notes to capture as much of the 
interviewee’s responses as possible). The KPWHRI or KPNW staff performing the interview will 
take notes and will make a note in the REDCap database indicating whether the participant 
gave verbal consent to both participate and record the interview. If the interview is performed at 
KPNW, the recording will be sent to KPWA via secure file transfer for transcription.  
The recording will be sent to a professional transcriptionist (Jackson Street Associates), with 
whom we have a Business Associate Agreement established, via secure file transfer to be 
transcribed. Interview transcripts will be returned to the study team via secure file transfer and 
stored in a secure project folder on the KP Washington network. Only BackInAction study staff 
will have access to the transcripts and will remove any identifiable information from the final 
transcripts. The audio files will be destroyed 5 years after the conclusion of the project.  
Study staff will send an incentive of $50 with a gift card to the stakeholder participant, if they are 
eligible to receive incentives, after completion of the interview.  
Randomization 
Patients will be randomized just after the baseline assessment has been completed. It is our 
intent that the baseline assessment is completed within a week of the eligibility screen 
(otherwise, back pain eligibility questions will need to be reassessed). Participants will receive 
$15 for completion of the baseline assessment. Participants are asked to make their first visit to 
acupuncture within 10 days of being randomized.  
6.2.3 Blinding 
This is an unmasked trial for participants, although the acupuncture participants will not know 
whether they are in the SA group or EA group until 10 weeks into the standard treatment period. 
Interviewers will be masked to treatment group for all standard study assessments. For 
qualitative data collection, interviewers are expected to be unmasked to participants treatment 
condition. Acupuncturists will not know whether their patients are in the SA or EA group until 10 
weeks into the standard treatment period.  
No members of the Core Executive Team (Multiple PI’s, site PI’s and the Statistical Methods 
Committee, which includes the study biostatisticians) will have access to the outcomes data 
during the trial. Conceivably, a site PI or one of the Multiple PI’s may become aware of an 
individual’s treatment group if they have an Adverse Event that requires the investigator 
intervene. One biostatistician, Mr. Wellman, may be supervising some data collection exercises 
with the programmers as needed, but datasets will not contain a treatment assignment variable 
prior to the locking of the database. All other members of the CEC will become unblinded after 
the data base is locked.  
 

 
35 of 61 
Version 1.9 
 
January 2024 
6.2.4 Follow-up Assessments 
 
Each participant will be followed for 12-months post-randomization. Participants will be invited to 
complete short monthly check-ins per their preferred mode (phone or web) between main 
assessments at 3-, 6- and 12-months. Monthly check-ins will take less than 5-minutes to 
complete and will be limited to administration of the PROMIS® Physical Function (6-items) and 
PEG (3-items). Participants will receive a $5 incentive for each check-in completed typically 
payable as a lump sum at the end of the study (up to $45 total for the 9 monthly check-ins). 
Patients will be contacted via their preferred mode (phone or web) for the 3-, 6-, and 12-
monthfollow-up surveys. Advance letters will be mailed as reminders to those preferring phone 
follow-up and emails with the reminder and a live hyperlink will be sent to those preferring to 
complete follow-ups online. Participants may opt to change their preferred mode at any time. 
Incentive payments of $20, $25 and $30 will be sent for completing 3-, 6- and 12-month follow-
ups, respectively. 
 
6.2.5 Completion/Final Evaluation 
 
The final 12-month assessment will include the same measures as those included in the 3-
month follow-up assessment battery.  
 
7. SAFETY ASSESSMENTS  
 
We will monitor patient safety for all individuals during their 12-month enrollment in the trial. 
Acupuncturists will perform an intake assessment, which will include a thorough understanding 
of the patient’s health relevant to the provision of acupuncture needling. The needling protocol, 
although broad, is based on care delivered in clinical practice47,48,55,99 and the highest quality 
trials.23,25,29,30,45 Our acupuncturists will be trained on the study protocol and reminded of best 
practices when treating older adults. They will be able to provide enough treatments to allow 
them to start with gentle treatments at the beginning for patients who are apprehensive about 
needling.   
 
We will select acupuncturists who have experience working with older adults and cLBP, and, if 
applicable, are already credentialed to provide acupuncture for patients within the local health 
care system. We will ensure that they review universal precautions and care guidelines in older 
adults. We will make sure that the older adults know how to prepare for their treatment (e.g., be 
fully satiated and hydrated in advance of a needling session). Although treatment is expected to 
be focused on needling treatment for cLBP, acupuncturists will tailor treatment to the 
presentation and needs of each participant. Acupuncturists will use only single-use pre-sterilized 
needles that are immediately discarded after use. This is already required of all acupuncture 
providers in the US. They will avoid needling areas of the skin that may have rashes or lesions. 
Finally, patients whose symptoms significantly worsen or who present with any new symptom 
will be referred to their PCP for evaluation. Medical care of patients invited to participate in the 
study will not be affected by their decision whether or not to participate. 
 
7.1  Specification of Safety Parameters 
 
Our study protocol is designed to minimize AEs with this population. Because electrical 
stimulation is prohibited, the needling treatment will be safe for patients with pacemakers. This 
study will comply with the national standard requiring acupuncturist to use only single-use (one-
time use), pre-sterilized needles that are discarded immediately after use. This practice reduces 

 
36 of 61 
Version 1.9 
 
January 2024 
risk of transfer of blood-borne pathogens and is already required of all acupuncture providers in 
all states where this pragmatic trial will be implemented. Acupuncturists are trained to avoid 
areas of the body where there are rashes, skin lesions or any breach in normal skin barrier. 
They will have flexibility in positioning the patient for treatment so that it is comfortable for the 
patient. Finally, patients whose symptoms significantly worsen will be referred to their PCP 
within their healthcare system.  
 
7.2   Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
 
Acupuncture has an excellent safety profile. Collectively, several large studies gathering data on 
adverse events from more than 235,000 patients33,34 and involving more than 63,000 treatments 
provided by 156 clinicians35,36 found that minor adverse events, for example bleeding or needle 
pain, are the most common, in the range of 1–10 in 100 patients for bleeding and hematoma 
and only 1–10 in 1000 for strong pain during needling.34 Further, Hopton37 found no evidence 
that patients who reported bothersome treatment reactions were less willing to try acupuncture 
again than those who did not, suggesting that most patients perceive common adverse events 
as minor. In a large trial of acupuncture for cLBP, 2.3% of patients reported a moderate adverse 
experience that was deemed likely due to treatment and only 1 of 477 reported pain lasting one 
month.25  The most commonly reported AEs were short-term pain, with one participant reporting 
dizziness and another, back spasms. Because acupuncture involves needle insertion, transient 
pain is possible, especially at acupoints in more sensitive regions of the body. The most serious 
adverse events, such as pneumothorax, infection, organ or tissue injury, persistent nerve pain, 
or needle breakage are very rare (typically 1 in 100,000 or less).34  
 
AEs reported by patients to their acupuncturists or study staff will be recorded and reported to 
appropriate regulatory bodies (single IRB and Independent Monitoring Committee (IMC)). 
Acupuncturists will record AEs on their treatment forms but alert the research team immediately 
if they are concerned about any AE or learn a participant is injured, needs hospitalization, trip to 
the emergency department or medical attention. In addition, patients will have the phone 
numbers of study staff to report any side effects they are concerned about in real time. We will 
collect data on “health problems that have interfered with your functioning for a few days or 
more that you think may have been caused by your study acupuncture treatment” using a 
mailed questionnaire sent to all acupuncture-randomized participants at 3 months after 
randomization and enhanced acupuncture participants again at 6 months after randomization. 
Any positive responses will be reviewed by study medical personnel and followed up by study 
personnel to obtain additional information on the patient’s condition, whether it has resolved or 
not, how long that took and whether the patient needed to modify their activities. The previous 
AE form we used for an acupuncture study (which we filled out based on data from the follow-up 
interview) included: anxiety, bruising, dizziness, fainting, fatigue, headache, nausea/vomiting, 
pain from needle insertion or stimulation, and other pain (including increased back pain). We 
graded non-serious AEs as mild, moderate and severe. We also included information on 
relatedness to treatment (definitely, probably, possibly, definitely not). Note, increased back pain 
is an expected variation in the natural history of cLBP and, as such, would not without 
concomitant disability be considered an AE for this study. 
 
7.3 
Adverse Events and Serious Adverse Events  
 
Acupuncture can have transient side effects as described in the previous section. For the 
proposed study, we are operationally defining a serious adverse event (SAE) as a death, 
hospitalization, prolongation of a hospitalization, or other serious or life-threatening event during 
a patient’s active participation in the trial. We will review/query active study participants’ EHR 

 
37 of 61 
Version 1.9 
 
January 2024 
data every month to identify deaths and hospitalizations among enrolled participants. In the 
case of a death, a chart review will be conducted by a physician at the clinical site to assess 
whether the death was related to the study intervention (definitely, probably, possibly, or 
unrelated to the study intervention). For hospitalizations, a study clinician at each HCS will 
review the list of diagnoses for possible relatedness to the acupuncture intervention. For any 
diagnosis at least possibly related to acupuncture, a more in-depth examination of the medical 
chart will be conducted. Because the number of hospitalizations in our older adult study 
population may be high and acupuncture poses only minimal risk, we do not plan to chart-
review hospitalizations as a matter of course. However, if our analytic reports suggest a 
possible increased risk of hospitalizations associated with acupuncture, we will work with our 
monitoring groups to develop a plan to do chart reviews on all or a subset of patients charts who 
were hospitalized. A non-serious AE will be defined as an unfavorable and unintended 
diagnosis, symptom, syndrome, or disease that occurs or worsens during the acupuncture 
intervention period and is plausibly related to acupuncture. We believe this definition is 
appropriate, given that older adults have many diagnoses, symptoms, and syndromes, most of 
which would be expected to be of longer duration and unrelated to acupuncture, for which AEs 
have typically been shown to be relatively brief in duration. Non-serious AEs will be collected in 
multiple ways: (1) at 3 and 6 months using a mailed questionnaire sent to all acupuncture-
randomized participants at 3 months after randomization and enhanced acupuncture 
participants again at 6 months after randomization asking about “health problems that have 
interfered with your functioning for a few days or more that you think may have been caused by 
your study acupuncture treatment”  ; (2) from participants who may phone the study team at any 
time to report AEs; and (3) via electronic acupuncturist treatment reports for events that occur or 
were reported in the acupuncturist’s office. Because acupuncture has relatively short-term 
physiological effects, we will not report AEs that first manifest more than 30 days after a 
participant’s final acupuncture treatment. 
 
We will classify each non-Serious AE using the following definitions: Mild (transient or minimal 
symptoms; no changes in activity level; no therapy or only symptomatic therapy; Moderate 
(symptomatic with moderate changes in activity level; no decrease in social activities; specific 
therapy required); Severe (incapacitating; bed rest; substantial decrease in social activities; loss 
of work). These definitions are consistent with the International Council for Harmonisation (ICH) 
standards in characterizing AEs. In the unlikely event that an adverse effect occurs that requires 
medical care, treatment will be provided according to each participants’ existing health care 
coverage. We will also assess the likely relatedness of the adverse event and acupuncture 
given the nature of the event, the timing related to treatment and any important contextual 
factors.  
 
Unanticipated problems that include risks to participants or others are defined by the Office for 
Human Research Protections as any incident, experience or outcomes that meets all the 
following criteria: 
 
1. 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the subject population 
being studied; 
 
2. 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
 

 
38 of 61 
Version 1.9 
 
January 2024 
3. 
Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
Unanticipated problems will be recorded in the data collection system throughout the trial.  
 
7.4  Reporting Procedures 
 
A report of SAEs will be reviewed by the PIs and Co-Investigators every six months and by the 
Independent Monitoring Committee (IMC) every six months. Reports of AE’s will be reviewed 
from the 3 and 6-month questionnaires at regular study meetings. They will be signed off by the 
Site PI and a study physician. If acupuncturists or patients report an AE, study staff will 
complete an AE form and follow-up with the patient as appropriate. Drs. Avins and Teets, our 
two physician site PIs and co-investigators and Dr. Nielsen, our acupuncture consultant, will be 
available as needed to assist with attribution of the AE to acupuncture and guidance on follow-
up. Non-serious AE’s will be reported to the IRB yearly and to the IMC at the next meeting.  
 
Incidents or events that meet the OHRP criteria for unanticipated problems will be reported to 
the IRB and the BackInAction (BIA) IMC.  We will report Unanticipated Problems to our NCCIH 
Program Director and the BIA IMC by submission of an Unanticipated Problem Report via fax or 
email to the IMC chair and via secure email to the NCCIH (Program Officer and OCRA).  
 
Per HHS regulations 46.103(b)(5), the “appropriate time frame for satisfying the requirement for 
prompt reporting will vary depending on the specific nature of the unanticipated problem, the 
nature of the research associated with the problem, and the entity to which reports are to be 
submitted”.  We will apply the following recommended OHRP and KPNC guidelines to satisfy 
prompt reporting requirements: 
 
• 
Unanticipated problems that are breaches of confidentiality or are deaths should be 
reported to the IRB and NCCIH (Program Director and OCRA) within 1 business day of 
the investigator becoming aware of the event. 
 
• 
Any other unanticipated problem should be reported to the IRB and NCCIH (Program 
Director and OCRA) within 5 business days of the investigator becoming aware of the 
problem. 
 
• 
All SAEs that are not unanticipated problems should be reported on a yearly basis to the 
IRB. 
 
• 
All unanticipated problems should be reported to appropriate institutional officials (as 
required by an institution’s written reporting procedures), the supporting agency head (or 
designee), and OHRP within one month of the IRB’s receipt of the report of the problem 
from the investigator. 
 
7.5 Follow up for Adverse Events 
 
For AEs related to acupuncture, we will follow patients from the time we learn about them until 
they are resolved. In our previous acupuncture studies, virtually all participants’ AEs were 
resolved within 1-2 weeks.  
 

 
39 of 61 
Version 1.9 
 
January 2024 
7.6  Safety Monitoring  
 
The 5-member Independent Monitoring Committee has expertise in acupuncture, biostatistics, 
Medicare data analysis, medicine, pragmatic trials, qualitative methods and research in chronic 
low back pain. They will have reviewed the protocol prior to commencement of the trial. They 
will meet on a schedule recommended by NCCIH, generally every 12 months. We anticipate 
that the IMC will identify reports that they will ask our study team to routinely prepare for their 
meetings. We expect that an approved IMC monitoring plan will be created by the IMC in 
conjunction with NIH study sponsors.  
 
8. INTERVENTION DISCONTINUATION  
 
The acupuncture study interventions may be discontinued if recommended by the participant’s 
acupuncturist or PCP. If the patient has a bad reaction to acupuncture (e.g., needle allergy) or is 
diagnosed with a condition that takes precedence over the acupuncture treatment (e.g., cancer, 
serious stroke), we will ask that they discontinue the study treatment. Patients can discontinue 
the intervention for any reason they choose. If possible, we will ask those participants to 
continue to complete their regularly scheduled outcome assessments for the standard 12- 
month enrollment period.  
 
9. STATISTICAL CONSIDERATIONS  
 
9.1  General Design Issues  
 
BackInAction (BIA) is a 3-arm multi-site randomized controlled trial of older adults with cLBP. 
Patients are randomized individually. Aim 1 includes two objectives: 
 
Aim 1 Primary Objective: Both standard and enhanced acupuncture will result in improved 
back-related disability compared to usual medical care at 6 months. We further hypothesize that 
enhanced acupuncture will be superior to standard acupuncture, albeit not expected to be a 
clinically important difference.  
 
Aim 1 Key Secondary Objective: To examine the effectiveness of acupuncture at 3 and 12 
months for improving back-related disability and to look at additional outcomes, including the 
PEG, a 3-item composite measure of pain intensity and pain interference with enjoyment of life 
and general activity at 3-, 6- and 12-months. 
 
Aim 2 Objective: To conduct a cost-effectiveness analysis of enhanced acupuncture and 
standard acupuncture compared to usual care.  
 
9.2  Sample Size and Treatment Assignment Procedures 
 
Older adults with cLBP will be randomized, in equal proportions, to one of three groups: Usual 
medical care (UMC), standard acupuncture (SA), or enhanced acupuncture (EA).  
 
We determined our sample size requirements for our primary outcome RMDQ at 6-months that 
focuses on detecting differences of each acupuncture group compared to UMC. Given a sample 
size of 630 total participants (210 per group) we have at least 90% power to detect a minimally 
clinically important difference (MCID) of two points on the RMDQ29,72 between each acupuncture 
group and UMC assuming a SD of 6 in each arm (consistent with results from previous 

 
40 of 61 
Version 1.9 
 
January 2024 
trials)25,41,100 and only testing for pairwise comparisons if the omnibus F-test is statistically at a 
0.05 α-level (to control for multiple comparisons). Accordingly, we have high power to detect a 
MCID difference between SA and UMC as well as EA and UMC. Nevertheless, if instead we 
assume that at 6-months SA attenuates to be equivalent to UMC and EA has a 2-point MCID 
improvement relative to both SA and UMC we will have 91% power to detect a difference 
between SA and EA as well as between UMC and EA. Thus, we are sufficiently powered 
(≥90%) to detect MCID differences between all pairwise group comparisons. Power was 
calculated via simulation studies using R software.  
 
For any two group comparisons, given our sample size of 210 per group and a SD of 6, the 
minimal detectable difference is 1.15 pts (i.e. the 95% CI width around difference in means 
between groups is +/- 1.15 pts).  Further, for secondary analysis for the binary outcome 30% 
improvement in RMDQ from baseline we have >90% power to detect an MCID assuming the 
probability of improvement in UMC was between 33%25 and 44%6 and the MCID was a 15% 
improvement above UMC for each of the acupuncture groups.  Assuming a 20% loss-to-follow-
up rate we inflated our sample size to 263 per group (789 total) to assure that we are well 
powered for all analyses of interest. (Assuming a more conservative 25% loss-to-follow-up rate 
we would inflate our sample size to 280 per group (840 total) to assure that we are well powered 
for all analyses of interest.) We will use an intent-to-treat approach in which participants will 
remain as randomized regardless if they withdrawal from treatment or cross-over to other 
treatment arm (e.g. UMC participant seeks acupuncture outside of study). 
 
Treatment Assignment Procedures 
 
After completion of baseline questionnaire, participants will be randomized via a computer-
generated randomization scheme in R developed by a study biostatistician in a 1:1:1 ratio to 
study condition (SA, EA, or UMC) stratified by HCS, age (65-74; 75-84; 85+) and sex. 
Stratification is only being used to maintain balance of treatment assignment with stratum and 
we do not have sample size requirements within a given stratum. We will employ random blocks 
of size 3 and 6 to ensure balance of groups over time as well as blinding of study team to next 
randomization assignment. The biostatistician will keep the randomization file in a secure folder 
only accessible to the programmer. The study programmer will be given the randomization 
scheme within specified strata and will only allow participants to be randomized once they 
consent and complete the baseline questionnaire. The study interviewer will press a button and 
the appropriate group assignment will appear. This method ensures that treatment allocation 
cannot be changed after randomization.  Further, at the time of randomization those randomized 
to SA or EA will only be indicated that they are randomized to acupuncture. Patients 
randomized to EA will not be informed that they have been selected to receive additional 
maintenance treatment sessions until close to the end of the first 3 months of treatment 
(approximately 10 weeks into the study) so that their treatment is unlikely to be altered by the 
knowledge of additional visits.  
 
After the randomization schemes have been generated by the biostatistician, the programmer 
will be the only one to have access to the randomization schemes that are embedded in the 
program. The coding will be held in a secure folder.  Other study personnel including principal 
investigators will only receive unmasked summary information after the completion of the 
intervention and the database is locked.  During the IMC reporting treatment assignment will be 
masked unless requested by the IMC. The programmer will run the reports for the IMC 
meetings. 
 

 
41 of 61 
Version 1.9 
 
January 2024 
9.3   Definition of Populations 
 
The intent-to-treat analysis will include everyone in the study population. The per protocol 
exploratory analysis will include everyone who adhered to the protocol for the SA, EA, and UMC 
groups. If someone crossed over into another group (i.e., they received no acupuncture but 
were randomized to acupuncture or they received acupuncture but were in the UMC arm), they 
will be considered as part of the group whose treatments resemble theirs as long as they met 
the requirements for the minimum number of treatments.  For adherence analyses we will 
include 1) participants in the acupuncture groups who, in the 3 months of standard acupuncture, 
received at least 8 treatments and the last visit indicated that they had completed treatment or 
received at least 12 treatments and 2) amongst those with last visit indicated that they had 
completed treatment (see section 5.4. for our proposed operationalization criteria for “completed 
treatment”).  
 
 
9.4   Interim Analyses and Stopping Rules 
 
We are not proposing any interim analyses and have no stopping rules. 
  
9.5   Outcomes  
 
9.5.1 Aim 1: Primary Outcome   
 
The Roland Morris Disability Questionnaire (RMDQ) is the primary outcome measure. Six 
months is the primary time point. For our primary outcomes, we will look at changes in the 
RMDQ score. 
 
9.5.2 Aim 1: Secondary Outcomes   
 
Secondary outcomes include the PEG as well as physical function and Patient Global 
Impression of Change for Pain. Three and 12 months are secondary time points. We will 
conduct analyses that look at changes in these scores at 3-, 6-, and 12-months. In addition, we 
will look at > 30% improvement in the RMDQ and pain intensity measures relative to their 
baseline values.  
 
9.5.3 Aim 1: Tertiary Outcomes 
 
Tertiary outcomes included PROMIS measure of ability to engage in social roles, anxiety, 
depression, fatigue, and sleep disturbance. If these back-focused treatments can impact other 
common complaints of patients with cLBP, then we would expect improvements in these 
domains if they are sufficiently frequent in our patients. While these are important domains for 
patients with cLBP, we consider them tertiary because there is little empirical evidence 
regarding acupuncture’s capacity to impact them. In addition, monthly measurements on the 
PEG and physical function, will be treated as tertiary outcomes and analyzed via exploratory 
analysis to understand the outcome trajectories. 
 
9.5.4 Aim 2: Outcome Measures 
 
We will measure effectiveness in terms of change in quality-adjusted life-years (QALYs) across 
the 12-month period calculated using the EQ-5D. Costs will be calculated from both the health 
care sector and the payer (Medicare) perspectives based on changes in all formal health care 

 
42 of 61 
Version 1.9 
 
January 2024 
sector (medical) costs and the portion of those costs reimbursed by Medicare, respectively.   
 
9.6  Data Analyses 
 
Aim 1 will evaluate the effectiveness of acupuncture and acupuncture plus maintenance relative 
to Usual Medical Care (UMC) at 3-, 6- (primary time-point), and 12-months after randomization.  
We will conduct a longitudinal analysis including the continuous outcome, change in Roland 
Morris Disability Questionnaire (RMDQ) from baseline (primary outcome) measured at all follow-
up times, in one model estimated using generalized estimating equations (GEE). We will use a 
working independence correlation matrix and will calculate standard errors using the robust 
sandwich estimator to account for within-person and within-in provider (some participants may 
see the same provider) correlation.101 We will include interactions between intervention groups 
and time (3-, 6-, and 12-months) to estimate time-specific intervention effects. Time will be 
included as a categorical variable. To gain power, since acupuncture and acupuncture plus 
maintenance at 3-months are the same intervention (maintenance period occurs between 3 and 
6 months post randomization and neither participants in the EA condition nor the acupuncturists 
treating them will be aware they will receive maintenance treatments until close to the 3-month 
follow-up), we will combine acupuncture groups at 3-month follow-up. We chose GEE as our 
analytic method because our primary outcome, RMDQ, is not expected to be normally 
distributed. From our experience working with RMDQ data, adjusting for baseline RMDQ value 
results in more normally distributed residuals. However, we didn’t want to make that assumption 
a priori and therefore chose GEE. 
 
For the 6-month time point we will conduct a sequential series of analyses.  We will first run a 
regression model with three groups (acupuncture [SA], acupuncture plus maintenance [EA] and 
UMC) for the 6-month follow-up.  We will then assess differences in change in RMDQ at 6-
months between the two acupuncture groups: with (EA) and without (SA) maintenance. If a 
statistically significant (α=0.05) and meaningful difference (>1 point difference) is found between 
the maintenance (EA) versus no maintenance (SA) groups (Scenario 1), we will further compare 
each of the acupuncture groups separately to UMC. Scenario 1 assessments will determine if 
acupuncture with maintenance (EA) is better than acupuncture without maintenance (SA) at 6-
months and if either or both acupuncture groups are better than UMC. If acupuncture groups do 
not differ at 6-months (Scenario 2), we will combine acupuncture groups for this time point and 
run a second regression model including only UMC and the combined acupuncture group. If this 
regression model shows that acupuncture is better than UMC, we will conclude that 
acupuncture improved RMDQ at 6-months, but maintenance was not shown to be efficacious.  
 
We will follow the same general framework for 12-month as we have specified for 6-months. 
Note that the analysis focused on the 12-month follow-up timepoint provides an important test of 
whether maintenance (EA) makes an appreciable difference over standard acupuncture in 
sustaining or improving the effect of acupuncture on pain-related functioning that endures after 
the end of treatment. Finally, note that we include all times points in a single model within this 
general modeling framework to handle correlation due to multiple outcomes on a given person. 
 
To control for multiple comparisons when testing between the three groups at 6-months we will 
use Fisher’s least significant (LSD) difference procedure.102 Fisher’s LSD has been shown to 
strongly hold the family-wise error rate at 𝛼𝛼-level for studies with three treatment groups.103 
Fisher’s LSD is a simple procedure where the global Wald-test of the null hypothesis of equal 
means for all groups is performed first. If this overall test is statistically significant then the 
sequential series of pairwise comparisons will be performed as outlined previously; otherwise 
the procedure stops, failing to reject the over null hypothesis that at least one mean is different 

 
43 of 61 
Version 1.9 
 
January 2024 
from the others. 
 
We will conduct a similar analysis for secondary and tertiary outcomes, including key secondary 
outcomes such as the PEG and will use appropriate link functions for non-continuous outcomes. 
All models will adjust for baseline outcome value, age, sex, and HCS as well as any baseline 
variables that are predictive of loss to follow-up. All analyses will be conducted following an 
intent-to-treat approach, including all individuals randomized regardless of their engagement 
with, or exposure, to the intervention. If loss to follow-up is above 15%, we will employ 
imputation techniques to address missing data issues.104 However, our focus will be on 
minimizing loss to follow-up and in our collective substantial experience conducting similar trials, 
we have consistently had retention in line with this. The imputation method that we were 
referencing uses a pattern mixture approach that relaxes the missing at random assumption. 
This approach that we propose using is derived for GEE and is sensitive to potential non-
ignorable missingness.104  
 
Exploratory analyses will further use tertiary outcome data collected monthly (i.e., the PEG and 
PROMIS®, Physical Function). We will use these measures to assess the trajectory of how long 
it takes until patients improve and to address questions such as “What proportion of people 
improve at three months if they don’t improve after one or two months of acupuncture?” These 
exploratory analyses will help address how much acupuncture is needed to improve and at what 
time, given a patient’s outcome trajectory, should acupuncture treatment stop if improvement 
has not been shown up to that time.     
 
We will conduct a set of prespecified moderator analyses using a similar analysis as Aim 1 
except include interactions with the moderator and treatment groups.  Moderators of interest 
include age (65-74; 75-84; 85+), patient expectations and gender. However, we do not 
anticipate being powered to detect a difference in treatment effects between men and women. 
According to results from the Acupuncture Trialists Collaboration, gender has not been 
consistently found to be related to benefits from acupuncture.105 We will look at race and 
ethnicity as well, but we will not be powered to detect a difference between groups. We have 
identified potentially important clinical conditions that may well diminish treatment effect (i.e., 
cognitive impairment, frail elderly, co-morbid pain conditions, co-morbid depression). If these 
are sufficiently common in our study participants, we will perform pre-specified moderator 
analyses. 
 
We will also conduct exploratory per protocol analyses assessing dose response to see if the 
effect changes dependent upon number of acupuncture treatments received and include UMC 
as having 0 treatments in the analyses.  We will flexibly model the trajectory of the primary 
outcome at 3 months by number of treatments to see if there is a threshold effect of treatment 
dose.  Further we will run adherence analyses comparing amongst those who adhered in the 3-
months of standard acupuncture (at least 8 treatments and last visit indicated by acupuncturist 
that they completed treatment or at least 12 treatments) compared to UMC and amongst those 
adhered to those who did not adhere within the acupuncture groups.  We will do a second set of 
adherence analyses but define adhered as only those that the acupuncturist indicated as 
completing treatment. Since these analyses are not intent-to-treat we will include further 
potential confounders that are associated with being non-adherent or receiving differential 
number of treatments. 
 
Aim 2: We will perform economic evaluations from both the payer (Medicare) and health care 
sector perspectives alongside the randomized pragmatic trial comparing usual medical care 
(UMC) to the addition of 3-months of acupuncture (SA) and 3-months of acupuncture and 3- 

 
44 of 61 
Version 1.9 
 
January 2024 
months of maintenance acupuncture (EA) in older adults with cLBP. Costs for the health care 
sector perspective will include the costs of all healthcare utilization priced using Medicare’s 
national fee for service rates, including acupuncture visits, and costs from the payer perspective 
will only include the Medicare covered amounts, including the reimbursed costs of 
acupuncture.106,107 Effectiveness will be measured using quality-adjusted life-years (QALYs) 
based on changes (net of baseline)108 in the preference-weighted90 values of the EQ-5D109 over 
the study year.  
 
If costs of either of the acupuncture arms compared to UMC are reduced and effectiveness 
increased, we will describe acupuncture as cost saving and to dominate UMC in terms of cost 
effectiveness.106 If incremental costs and effectiveness are both increased then an incremental 
cost-effectiveness ratio will be calculated and compared to society’s willingness to pay for an 
additional QALY ($50,000 to $100,000 per QALY110) to see if acupuncture can be considered 
cost-effective. 
 
Acupuncture implementation costs will be captured from study records in terms of the number of 
treatments received in 15-minute units and valued at typical community rates. For the payer 
perspective, we will use several assumptions regarding the amount of these costs reimbursed 
by Medicare with our base case based on typical acupuncture reimbursement rates (or trial 
allowable costs per Medicare). We would prefer to capture all healthcare utilization and cost 
data for the year before and after baseline from CMS for each patient in the study. However, 
this is unlikely given the time constraints of our project and when Medicare data are available. In 
addition, Medicare/CMS data will not include healthcare utilization for those not currently on 
Medicare (e.g., still on employer insurance or getting care at the VA). Since KPNC and KPWA 
tend to provide all care for their patients, we should be able to capture full healthcare utilization 
from their EHRs and price it using Medicare rates. SH provides most of their participants’ care 
and we will explore whether we can use a similar pricing scheme for their participants. However, 
IFH only provides primary care. Therefore, the IFH EHR will only contain information on primary 
care-related healthcare utilization and incomplete information on referrals to specialists and 
hospitalizations. We will be limited to the data we can obtain in a timely manner from Medicare 
for IFH participants.  
 
A bootstrap methodology will be used to estimate confidence intervals,111,112 and one-way 
sensitivity analyses will be performed to determine the robustness of our estimates with different 
assumptions such as the reimbursement rate for acupuncture and the inclusion of back-pain 
related costs only.106  
 
The cost-effectiveness analysis will be conducted by Dr. Patricia Herman with assistance from 
Dr. Samuel Mann at RAND in Santa Monica, California using de-identified data obtained from 
the Coordinating Center. 
 
Aim 3 (Qualitative Analyses): All interviews will be audio recorded. and the participant and 
stakeholder interviews will be transcribed by a professional transcriptionist; the acupuncturist 
interviews will be automatically transcribed by Teams and then reviewed by study team 
members.  Focus groups with patients and acupuncturists will be transcribed in real time by a 
court reporter (IFH, KPNC and KPWA) or by a transcription service after-the-fact. Coding will be 
completed by trained coders using ATLAS.ti, a qualitative analysis software program that aids 
management and interpretation of text-based and other non-quantitative data. Coder reliability 
will be ensured through using an iterative process of coding the same text and comparing codes 
and discussing discrepancies. Code definitions will be updated as needed to ensure clarity. 

 
45 of 61 
Version 1.9 
 
January 2024 
Once the interviews are coded for each phase of the study (see Section 6.2.2. Aim 3 data 
collection), we will use ATLAS.ti queries to produce reports of text associated with primary 
codes and begin synthesizing themes from this text. ATLAS.ti allows retrieval of coded 
information in multiple ways, including by participant features (e.g., gender, pain diagnoses) by 
a code alone, or by combinations of co-occurring codes. This approach to coding and data 
reduction will allow us to examine issues from multiple perspectives and ensures a thorough 
review of the data increase the breadth and depth of insights generate from the qualitative data 
gathered.   
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
 
10.1 
Data Collection Forms  
 
Staff at KPWHRI will develop the oral eligibility screening language and the baseline, monthly, 
3, 6 and 12-month follow-up questionnaires. After consent, all sites will transfer data on 
participants to the centralized data capture system, Discovery, at KPWHRI. Data collection at 
baseline will be conducted by site staff using Discovery. KPWHRI Survey Research Program 
will do all follow-up assessments. These will be done by computer assisted telephone 
interviewing (CATI at 3-, 6-,12-month follow-ups), web (3-, 6-,12-month follow-up and monthly) 
or both, depending on the needs to each participant. These data will be considered primary 
source data. All interviewers will be masked to treatment group.   
 
10.2 
Data Management  
 
A detailed data-quality management program including specific protocols for data collection and 
quality control will be developed by our KPWHRI Data Coordinating Center (DCC)[see Section 
12] with input from pertinent staff across our performance sites during the UG3 phase.  
 
For this study, Kaiser Permanente Washington Health Research Institute (KPWHRI) will serve 
as the Data Coordinating Center (DCC). Individual sites will be responsible for participant 
tracking throughout the pre-consent phase, and after consent, all primary data collection will be 
conducted using Discovery: DatStat’s Research Management System (DD-RMS). DD-RMS is 
a self-hosted module of DatStat housed on servers at KPWA. All data input into the system are 
stored in a database server located behind the organizational firewall, with limited access 
between web server and database server. DD-RMS is built on the .Net platform, offers an open 
architecture and well-documented API, and is designed to streamline study management, 
participant management, data capture, aggregation, and reporting within and across complex 
research studies. As a web-based application, the DD-RMS provides a single, secure point of 
access and supports centralized studies and multi-site collaborative research efforts. DD-RMS 
has built-in flexibility to support the range of healthcare system-specific study workflows 
necessary during the process of participant identification and recruitment, including provisions 
for role-based access and privileges such that only local HCS staff can access patient health 
information prior to consenting when participant permissions are given that will allow for the 
KPWHRI DCC staff to manage all patient data for follow-up assessments and other linkage 
needs. The DD-RMS includes functionality for survey form development and data capture, 
management, and quality control. The system is designed to track most all study related 
information and provides a single point of access for all users (research coordinators, 
interviewers, and study patient participants. (Acupuncture treatment data will be collected in 
Epic at IFH and in another database, described below, for the other sites.). The DD-RMS 
supports multimodalities for data collection including web-based data form completion, 
telephone interviewer form support, and batched paper form entry. The system records and 

 
46 of 61 
Version 1.9 
 
January 2024 
tracks all study contacts (e.g., calls, visits, emails, mailings) and associated outcome status as 
well as having the functionality to manage sampling and random assignment. DD-RMS has 
been approved by KPWA’s Institutional Review Board as a tool that can be used for secure 
collection and storage of data, including PII/PHI.  
 
The DD-RMS will be the coordinating center’s primary electronic data capture and management 
system and used exclusively to house and manage patient and intervention-related study data 
after participants are consented for the study. However, regulatory, compliance, and 
information-security technology reviews (TRO, SRA, etc.) are required by all participating health 
care systems prior to housing patient data. As this is a lengthy process and is still underway at 
the writing of this report, we have planned for back-up EDC and management systems at each 
of our satellite performance sites (KPNC, SH, and IFH) to manage patient data within the 
firewalls of the patients HCS prior to consent as described below. 
 
Individual Sites 
KPNC: For pre-consent data tracking, programmers at KPNC will build a recruiting tracking 
system utilizing Microsoft Office 365 Access. Standard procedures for tracking recruitment of 
trial participants will be employed. 
SH: For pre-consent data tracking, programmers at SH will build a recruiting tracking system 
utilizing Microsoft Access 2013. Standard procedures for tracking recruitment of trial participants 
will be employed. 
IFH: For pre-consent data tracking, programmers at IFH will build a recruiting tracking system 
utilizing REDCap (version 9.9.2). Standard procedures for tracking recruitment of trial 
participants will be employed.  
 
All our performance sites (KPWA, KPNC, SH, KPNW, and IFH) are HIPAA-covered entities and 
comply with all HIPAA regulations regarding data security. All study files maintained at any of 
our affiliated research institutes will be maintained either behind secure firewalls on system 
network drives, in a centralized location on the institute servers or in locked file cabinets.  
Access to these data will be password protected and subject to the same security protections as 
other confidential health plan data.  Access will be limited to staff working on this study who 
require access to these files. Whenever possible, study data will be stored on our central study 
DatStat tracking system. All staff at our participating sites are trained in appropriate security 
protections, computer passwords are changed on a regular basis, and all staff sign annual 
confidentiality agreements.  Data transferred from sites to KPWHRI will be done via a web-
based secure file transfer (SFT) application, which uses the 128-bit Secure Sockets Layer 
encryption protocol and meets the 2009 HIPAA HITECH safe harbor standard.  This method is 
commonly used in our multi-site studies and has been reviewed and approved by our IRBs. No 
data or identifiable information will be stored on participants’ phones or devices.  No sensitive 
information will be shared in texts or emails with participants. The DCC at KPWA will securely 
transfer identifiable datasets and de-identified datasets via the SFT application to study sites 
(KPNC, Sutter, IFH, KPWA, KPNW) for analyses when applicable data sharing agreements are 
in place. 
 
Clinical sites will be responsible for recruitment (outreach, assessment of eligibility, consent, 
baseline data collection and randomization) and connecting the patients to acupuncturists. By 
using centralized databases, we will be able to have standardized reports to the extent possible. 
The DCC will prepare the randomization schemes and insert them into the proper location in the 
computer program for the baseline interviews. The Survey Research Program at KPWHRI will 
conduct all follow-up interviews and outreach. The study sites will manage all acupuncture 
visits. Treatment data will be collected in Epic (IFH) or a study-specific data base for the 

 
47 of 61 
Version 1.9 
 
January 2024 
acupuncturists. KPWHRI staff will monitor progress, look for outliers in various treatment 
parameters and inform the acupuncture training team and site staff of any issues they detect. 
Section 10.3.5 describes monitoring in more detail.   
 
KPWHRI will also build a password-protected HIPAA compliant SQL server database with a 
web-interface that contains the treatment data from all acupuncturists (KPNC, KPWA, SH) who 
do not chart in Epic (IFH). It will contain appropriate range and logic checks as well. Participants 
will be tracked by study identifier in this database.  
 
10.3 Quality Assurance  
 
10.3.1 Training 
 
Protection of Human Subjects Training: All study personnel, including investigators, staff, 
and study acupuncturists, will complete the required training on the protection of human 
subjects before they engage in any human subjects activity. They will recertify on the schedule 
required by their institution.  
 
Training of Study Site Coordinators: The site study coordinators will meet virtually for a 
training that will be developed during July of the UG3 year. Training will begin with a review of 
our study documentation (e.g., study protocol, manual of procedures, consents, questionnaires). 
We will also discuss communication with patients, acupuncturists and physicians. We will 
describe our database and data management, including our agreed upon procedures. We will 
have role playing as appropriate. We will incorporate cultural competency training in this training 
process. We will have ongoing training for quality assurance every six months during site visits 
or internal audits with the project manager. 
 
Training of Acupuncturists: During the UG3 phase of the study, we developed materials to 
orient the acupuncturists to the cLBP trial specifics including the study protocol, number of 
sessions in each arm, the parameters of the consensus intervention protocol, minimum number 
of sessions recommended, when to discontinue treatment for failure to respond, compliance on 
recording a session using the trial treatment forms, tracking and reporting adverse events, 
procedures for communicating with participating patients’ PCP. We developed procedures for 
acupuncturists to ask questions as issues come up and in turn how we will communicate that 
information to all study acupuncturists. Additionally, a review of harms risks will be required 
including safe needling practices and appropriate adaptations for older adults. Finally, each site 
will train their acupuncturists on site-specific procedures for getting paid and any other site-
specific procedures (e.g., who to contact to report a concerning adverse event. Acupuncturist 
trial training will be presented in webinar format, using PowerPoint and recorded so it is 
accessible to acupuncturists for re-viewing and to new study acupuncturists for training 
throughout the treatment period. PDFs of material will be included in the training packet as well 
as a short quiz of the safety presentation. Materials on safety were developed by Dr. Arya 
Nielsen based on an existing NCCAOM accredited webinar on acupuncture therapy risks and 
harms.113 After completing our training as well as a quiz covering the key components of the 
treatment and safety, acupuncturists will be certified for participation in the study.  
 
Training of Interviewers: The Survey Research Program at KPWA has a rigorous foundational 
training program for all Research Interviewers. In addition, Interviewers train for specific studies, 
growing familiar with study goals, protocols and recruitment and survey instruments. Study 
training involves multiple learning activities to ensure that Interviewers are well prepared to 
engage with study participants. Typical training includes an introduction from the study 

 
48 of 61 
Version 1.9 
 
January 2024 
investigator and project manager, review of study materials including advance letters, 
brochures/information sheets, consent forms, as well as time dedicated to practice and role play 
study scripts. Training materials include a quick reference guide of recommended responses for 
known or anticipated frequently asked questions. Post training, Interviewers debrief their 
learnings, noting any questions and sharing their experiences with the survey instruments.  
 
Research Interviewers conduct interviews and administer surveys via Computer Assisted 
Telephone Interviewing. CATI programming is tested for range and logic for each variable. The 
Survey Research Program will work with all sites and share resources to ensure that all 
recruiters and baseline interviewers have comparable training. Cultural competency training will 
be incorporated in the interviewer training.  
 
Training of Qualitative Interviewers: Dr Clarissa Hsu or another team member with expertise 
in qualitative methods will ensure that all the qualitative interviewers have been appropriately 
trained so that the qualitative data collection optimizes resources and efficiently addresses 
study activities essential to Aim 3.  This will include ensuring that all qualitative interviewers 
have sufficient training in qualitative interviewing and focus group facilitation and that they 
understand the intent of all questions to be able to probe and guide conversation effectively and 
efficiently. Dr. Hsu and other qualitative methods experts will organize oversight of study 
qualitative activities by assessing the training and experience of each person participating in 
qualitative data collection via a phone conversation, reviewing any interview/facilitation guides 
with qualitative team members and having individuals observe one or more focus 
groups/interviews facilitated by Dr. Hsu or another experienced team member followed by a 
group debrief session.   
 
10.3.2 Quality Control Committee  
 
The Study PI’s, site PI’s, a biostatistician, and other Co-I’s and senior study staff as needed, will 
meet weekly (or bi-monthly if the study is recruiting without difficulty) to keep abreast of the day-
to-day operations at each performance site and help if needed. This group will discuss the 
progress of the trial, recruitment and any safety or IRB concerns.  
 
10.3.3 Metrics 
 
We will collect the information necessary to ensure that we can report trial flow according to the 
CONSORT diagram.114 Reports will include the number of referrals, letters sent out, number of 
contacts to study, number of phone screens and outcomes, and other elements of the 
enrollment process. Less frequently, we will obtain data on age group, gender, race and 
ethnicity and summaries of completed acupuncture treatments. For each monthly follow-up 
survey, we aim to achieve an 85% or higher follow-up rate. We will utilize a combination of web-
based survey and telephone outreach to achieve maximal survey response – especially at the 
main 3-, 6- and 12-month follow-up time points. Reminder emails, letters or phone calls – 
depending on each participant’s needs - will be provided the week before the surveys are due. 
Survey completion rates will be primarily based upon the completion of functional outcome and 
pain-related measures, but our data management team at KPWHRI will additionally tabulate 
follow-up by each instrument to monitor and evaluate survey burden. We will also create reports 
for the acupuncture treatments to monitor adherence to the intervention protocol. We anticipate 
that there will be other metrics we will use that will become clear to us as we delve more deeply 
into the database build and after discussion of our study with the Protocol Review Committee.   
 

 
49 of 61 
Version 1.9 
 
January 2024 
10.3.4 Protocol Deviations 
 
We define a protocol deviation as any lack of compliance with the study protocol, manual of 
procedures or other approved study procedures that does not result in increased risk to the 
participant or integrity of the study. For example, failure to obtain all follow-up data from a 
participant. We will define a protocol violation as any lack of compliance with the study protocol, 
manual of procedures or other approved study procedures that could increase risk to the 
participant or integrity of the study. For example, enrolling a participant who does not meet the 
inclusion and exclusion criteria. Protocol deviation and violations will be tracked prospectively, 
captured in real time and reviewed at regularly scheduled full study team meeting as well as 
logged for IRB and Independent Monitoring Committee review as required.  
 
10.3.5 Monitoring 
 
We will implement procedures to review electronic consent forms, signed acupuncture consent 
forms as well as documentation of oral consent. For data captured electronically, we will 
generate summary reports on a weekly basis to review the recruitment process and conduct of 
the trial. Reports and findings will be shared across sites and the programmers from all sites will 
contribute to the finalized, curated code to ensure adequate recognition of site-specific issues 
and consistency in operation, implementation and documentation. Evaluation and monitoring 
will also be conducted via site visits or structured internal audits, where specific issues can be 
addressed and remediated. 
 
The data manager from our KPWHRI survey department will run and review data quality and 
missing data reports on a weekly basis for the follow-up interviews. Free text data collection 
from study participants will be minimized to the extent possible and field masking and 
automated out of range checks will be implemented where applicable. 
 
We will run reports from the treatment data collected by the acupuncturists to ensure that they 
are adhering to the protocol. These processes will be described in the Manual of Procedures 
and details will be fleshed out during the last several months of the UG3 year and the first 
month of the UH3 year. 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 
11.1 Institutional Review Board (IRB) Review  
 
This protocol, the informed consent documents (Appendix 3), and any subsequent modifications 
will be reviewed and approved by the KPNC IRB, who will be responsible for overall oversight of 
the UH3 clinical trial (sIRB of record). The consent form should be separate from the protocol 
document. The Institute for Family Health, KPWA and SH will yield to the KPNC IRB. The KPNC 
IRB will be apprised of any differences in state laws and customs of the other health care 
institutions that may require customization of consent forms for each performance site. The 
sIRB may require different procedures for some of the processes we have described (e.g., 
adverse event monitoring). If so, those changes would be made. 
 
11.2 Informed Consent Forms 
 
All sites will ask for a waiver of written consent to screen prospective participants using a 
structured eligibility screener.  

 
50 of 61 
Version 1.9 
 
January 2024 
 
FOR HCSs PERMITTING ORAL CONSENT  
In addition, at some sites, individuals will have received a consent checklist that carefully lays 
out the elements of informed consent and HIPAA. The interviewers will make sure the 
participant has the checklist in front of him/her and will then review each element, make sure 
that prospective participants understand each element and are comfortable providing oral 
informed consent. This will be documented in the computer assisted interviewing program with 
date, time, the interviewers name and the participants name.  
 
FOR HCSs REQUIRING WRITTEN CONSENT  
An electronic signed consent form will be obtained from each participant. The consent form will 
include all necessary elements of informed consent including a description of the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. They will be 
able to print a signed copy for their records, and this fact will be documented in the participant’s 
study record. 
 
11.3 Participant Confidentiality  
 
We will maintain strict patient confidentiality through several means. All study staff (including the 
acupuncturists) are required to complete training regarding principles and procedures for 
protecting the confidentiality of health information. Only staff who need to see particular data will 
be given access to those files. All information needed to recruit patients (name, address, phone 
number) will be stored in password protected databases (with strong passwords with timeouts 
and behind the firewalls of each HCS) and/or locked file cabinets. At the time of enrollment, 
participants will be assigned a unique study identifier (SID). After participants are enrolled and 
baseline data collected, their minimum-necessary contact information and pertinent electronic 
health record data will be securely transferred to the Survey Research Program at the Kaiser 
Permanente Washington Health Research Institute Data transferred from sites to KPWHRI (via 
a web-based secure file transfer (SFT) application; see section 10.2) for all follow-up interviews. 
Data will be stored securely in DatStat. Contact information will be needed to collect follow-up 
data but will be stored in a password protected database behind the KPWHRI firewall and will 
be available only to personnel who need to collect the follow-up data. The database will have 
multiple levels of permissions so that only those needing the contact information will have 
access to it. Language to explain the process will be included in the consent form so that 
participants will be informed.  
 
Any data files created for research use will include no identifying information (name, health plan 
number, birth date) and records will be identified only by SID. Only site study programmers will 
have access to the crosswalk linking SIDs to health plan member numbers.   
 
Acupuncturists will complete electronic visit forms, but they will only include the participant’s ID 
number, dates and other details of the treatment so it will not be possible to identify individuals. 
If we have a need to transmit information about a patient to the acupuncturist, we will call their 
office. 
 
Paper records will be kept in locked filing cabinets in secure research areas. Data collected at 
follow-up time points will be stored by ID number only. Information will not be released without 
the express consent of the participants. Any study participant information stored temporarily at 
an acupuncturist’s office while the participant is undergoing treatment will be stored using 
HIPAA-compliant procedures. 
 

 
51 of 61 
Version 1.9 
 
January 2024 
Any data, forms, reports, audio recordings, and other records that leave the site will be identified 
only by a study identification number (SID) to maintain confidentiality. All records will be kept in a 
locked file cabinet. All computer entry and networking programs will be done using SIDs only. 
Information will not be released without written permission of the participant, except as necessary 
for monitoring by IRB, the NCCIH, and the OHRP. 
 
11.4 Study Discontinuation  
 
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP or other 
government agencies as part of their duties to ensure that research participants are protected.  
 
12. COMMITTEES  
 
Study Principal Investigators and Core Executive Committee (CEC) 
 
Drs. Lynn DeBar and Andrea Cook will serve as MPIs on this project. They will be responsible 
for implementation of the Specific Aims and will ensure that systems are in place to guarantee 
institutional compliance with US laws and federal policies including human research, data and 
facilities. They will be assisted by the Core Executive Committee (CEC), which will include the 
site- PI’s at IFH, KPNC and Sutter, the Statistical Methods Committee (SMC), which will 
include the biostatisticians and cost-effectiveness expert, other project content experts (in 
geriatrics, acupuncture, qualitative methods). The CEC will meet regularly to handle any major 
study decisions regarding the direction of scientific aims, allocation of resources, disputes that 
may arise, and other information related to the management of the proposed project. As 
appropriate, they will receive guidance from the other investigators on the team, consultants 
and study staff. Major study decisions will be made by vote of the CEC. The odd number of 
core executive team members eliminates the chance of a tie.  
 
Statistical Methods Committee (SMC) 
 
Dr. Andrea Cook will chair the SMC, which will interface with the NIH Collaboratory 
Biostatistics and Study Design core. The SMC will include Mr. Wellman and Dr. DeBar as ex-
officio members. Dr. Herman will join the SMC for analytic strategies related to Aim 2. The 
SMC will refine the overarching analytic strategy and if additional scientific input is needed, 
reach out to the CEC. The CEC is responsible for all final decisions about the scientific aims, 
allocation of resources for statistical investigations, and resolution of disputes will be made by 
the CEC. Members will also serve as project liaisons to the NIH Collaboratory Working Groups. 
 
NIH Leadership 
 
Dr. Lanay Mudd will serve as the Program Officer from NCCIH and Drs. Robin Boineau from 
NCCIH (December 2019 to February 2022) and Basil Eldadah from NIA will be the Project 
Scientists. They will meet regularly with Drs. Cook and DeBar and will provide oversight and 
advice. As needed, other members of the scientific or study staff will join these meetings. 
 
Data Coordinating Center (DCC) 
 
Drs. DeBar and Cook in collaboration with the SMC will oversee the Data Coordinating Center 
for the study. KPWHRI was chosen as the Data Coordinating Center because there is an 
existing infrastructure that has been established through the KPWHRI Survey Research 
Program that will support screening, baseline, monthly check in and 3-, 6-, and 12-month follow 

 
52 of 61 
Version 1.9 
 
January 2024 
up assessments. Drs. DeBar and Cook each have substantial experience in multi-site 
collaborations involving both primary data collection from patients and secondary data 
collection from electronic medical records. However, they will remain masked to treatment 
outcomes until the data base is finalized and locked. 
 
Independent Monitoring Committee 
 
Approved by NCCIH, the IMC plays a crucial role in ensuring the safety and welfare of patients 
enrolled in this trial, and operates without undue influence from any interested party, including 
BIA study investigators or NCCIH staff. IMC responsibilities include protocol approval, interim 
review of trial enrollment, protocol compliance, and safety data. The protocol review committee 
is comprised of the same members as the IMC and is referred to such during the UG3 
preparatory phase of the study.  
 
13. PUBLICATION OF RESEARCH FINDINGS  
Publication of the results of this trial will be governed by the policies and procedures developed 
by the CEC. Any presentation, abstract, or manuscript will be made available for review by the 
NCCIH and NIH Collaboratory Publications Committee prior to submission.  
 
14. DATA SHARING 
 
This study will comply with all applicable NIH Data Sharing Policies. (See 
https://grants.nih.gov/policy/sharing.htm for policies and resources) 
The DCC will produce a public/releasable database from the study. The releasable 
database will be completely de-identified in accordance with the definitions provided in 
the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers 
specified in HIPAA will be recoded in a manner that will make it impossible to deduce or 
impute the specific identity of any patient. The database will not contain any institutional 
identifiers.  
The DCC will also prepare a data dictionary that provides a concise definition of every 
data element included in the database. If specific data elements have idiosyncrasies 
that might affect interpretation or analysis, this will be discussed in the dictionary 
document. Data elements that are considered unreliable will be deleted, and this will be 
noted in the documentation. 
The policies for release of this database will be determined by the NIH.  These policies 
are expected to focus primarily on the timing of data release. The preliminary plan is to 
release the database at the time of publication of the primary manuscript.  
Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy 
as outlined at https://heal.nih.gov/about/public-access-data. 
In accordance with policies of the NIH, the DCC will send the releasable database and 
its relevant documentation to the entity determined by the NIH or specific institute to be 
the repository for data created under the HEAL initiative.   

 
53 of 61 
Version 1.9 
 
January 2024 
Access to the releasable database housed in the NIH-assigned repository will be in 
accordance with procedures and regulations of the NIH or specific institute.  
 
  
 
 

 
54 of 61 
Version 1.9 
 
January 2024 
14. REFERENCES  
 
1. 
Hoy D, March L, Brooks P, et al. The global burden of low back pain: 
estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 
2014;73(6):968-974. 
2. 
Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among 
adults with back and neck problems. JAMA. 2008;299(6):656-664. 
3. 
Weiner DK, Rudy TE, Morrow L, Slaboda J, Lieber S. The relationship 
between pain, neuropsychological performance, and physical function in 
community-dwelling older adults with chronic low back pain. Pain Med. 
2006;7(1):60-70. 
4. 
Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: 
time to back off? J Am Board Fam Med. 2009;22(1):62-68. 
5. 
Docking RE, Fleming J, Brayne C, et al. Epidemiology of back pain in older 
adults: prevalence and risk factors for back pain onset. Rheumatology 
(Oxford). 2011;50(9):1645-1653. 
6. 
Rundell SD, Sherman KJ, Heagerty PJ, Mock CN, Jarvik JG. The clinical 
course of pain and function in older adults with a new primary care visit for 
back pain. J Am Geriatr Soc. 2015;63(3):524-530. 
7. 
Arnstein P. Balancing analgesic efficacy with safety concerns in the older 
patient. Pain Manag Nurs. 2010;11(2 Suppl):S11-22. 
8. 
Weiner DK. Deconstructing chronic low back pain in the older adult: 
shifting the paradigm from the spine to the person. Pain Med. 
2015;16(5):881-885. 
9. 
Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent 
pain in the older patient: a clinical review. JAMA. 2014;312(8):825-836. 
10. 
Jarvik JG, Gold LS, Comstock BA, et al. Association of early imaging for 
back pain with clinical outcomes in older adults. JAMA. 2015;313(11):1143-
1153. 
11. 
Barkin RL, Beckerman M, Blum SL, Clark FM, Koh EK, Wu DS. Should 
nonsteroidal anti-inflammatory drugs (NSAIDs) be prescribed to the older 
adult? Drugs Aging. 2010;27(10):775-789. 
12. 
Cooper JW, Burfield AH. Assessment and management of chronic pain in 
the older adult. J Am Pharm Assoc (2003). 2010;50(3):e89-99; quiz e100-
101. 
13. 
Fitzcharles MA, Lussier D, Shir Y. Management of chronic arthritis pain in 
the elderly. Drugs Aging. 2010;27(6):471-490. 
14. 
Institute of Medicine (US) Committee on Advancing Pain Research Care 
and Education. Relieving pain in america: a blueprint for transforming 
prevention, care, education, and research. Washington (DC): National 
Academies Press; 2011. 
15. 
Interagency Pain Research Coordinating Committee. National pain 
strategy: a comprehensive population health-level strategy by pain. 2015. 
16. 
Reid MC, Ong AD, Henderson CR, Jr. Why we need nonpharmacologic 
approaches to manage chronic low back pain in older adults. JAMA Intern 
Med. 2016;176(3):338-339. 

 
55 of 61 
Version 1.9 
 
January 2024 
17. 
Townley S, Papaleontiou M, Amanfo L, et al. Preparing to implement a self-
management program for back pain in new york city senior centers: what 
do prospective consumers think? Pain Med. 2010;11(3):405-415. 
18. 
Nascimento P, Costa LOP, Araujo AC, Poitras S, Bilodeau M. Effectiveness 
of interventions for non-specific low back pain in older adults. a systematic 
review and meta-analysis. Physiotherapy. 2018. 
19. 
Qaseem A, Wilt TJ, McLean RM, Forciea MA, Clinical Guidelines Committee 
of the American College of Physicians. Noninvasive treatments for acute, 
subacute, and chronic low back pain: a clinical practice guideline from the 
american college of physicians. Ann Intern Med. 2017;166(7):514-530. 
20. 
Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back 
pain: a systematic review for an american college of physicians clinical 
practice guideline. Ann Intern Med. 2017;166(7):493-505. 
21. 
Turk DC, Dworkin RH, Revicki D, et al. Identifying important outcome 
domains for chronic pain clinical trials: an IMMPACT survey of people with 
pain. Pain. 2008;137(2):276-285. 
22. 
Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for chronic pain: 
update of an individual patient data meta-analysis. J Pain. 2018;19(5):455-
474. 
23. 
Cherkin DC, Eisenberg D, Sherman KJ, et al. Randomized trial comparing 
traditional Chinese medical acupuncture, therapeutic massage, and self-
care education for chronic low back pain. Arch Intern Med. 
2001;161(8):1081-1088. 
24. 
Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of 
a short course of traditional acupuncture compared with usual care for 
persistent non-specific low back pain. BMJ. 2006;333(7569):623. 
25. 
Cherkin DC, Sherman KJ, Avins AL, et al. A randomized controlled trial 
comparing acupuncture, simulated acupuncture, and usual care for chronic 
low back pain. Arch Intern Med. 2009;169(9):858-866. 
26. 
Molsberger AF, Mau J, Pawelec DB, Winkler J. Does acupuncture improve 
the orthopedic management of chronic low back pain - a randomized, 
blinded, controlled trial with 3 months follow up. Pain. 2002;99(3):579-587. 
27. 
Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in patients with chronic 
low back pain: a randomized controlled trial. Arch Intern Med. 
2006;166(4):450-457. 
28. 
Weidenhammer W, Linde K, Streng A, Hoppe A, Melchart D. Acupuncture 
for chronic low back pain in routine care: a multicenter observational 
study. Clin J Pain. 2007;23(2):128-135. 
29. 
Haake M, Muller HH, Schade-Brittinger C, et al. German Acupuncture Trials 
(GERAC) for chronic low back pain: randomized, multicenter, blinded, 
parallel-group trial with 3 groups. Arch Intern Med. 2007;167(17):1892-1898. 
30. 
Witt CM, Jena S, Selim D, et al. Pragmatic randomized trial evaluating the 
clinical and economic effectiveness of acupuncture for chronic low back 
pain. Am J Epidemiol. 2006. 

 
56 of 61 
Version 1.9 
 
January 2024 
31. 
Liu L, Skinner MA, McDonough SM, Baxter GD. Acupuncture for chronic 
low back pain: a randomized controlled feasibility trial comparing treatment 
session numbers. Clin Rehabil. 2017;31(12):1592-1603. 
32. 
McKee MD, Nielsen A, Anderson B, et al. Individual vs. Group Delivery of 
Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary 
Care – A Randomized Trial. J Gen Intern Med. 2020;in press. 
33. 
Macpherson H, Scullion A, Thomas KJ, Walters S. Patient reports of 
adverse events associated with acupuncture treatment: a prospective 
national survey. Qual Saf Health Care. 2004;13(5):349-355. 
34. 
Witt CM, Pach D, Brinkhaus B, et al. Safety of acupuncture: results of a 
prospective observational study with 229,230 patients and introduction of a 
medical information and consent form. Forsch Komplementmed. 
2009;16(2):91-97. 
35. 
MacPherson H. How safe is acupuncture? Developing the evidence on risk. 
J Altern Complement Med. 1999;5(3):223-224. 
36. 
White A, Hayhoe S, Hart A, Ernst E. Adverse events following acupuncture: 
prospective survey of 32 000 consultations with doctors and 
physiotherapists. BMJ. 2001;323(7311):485-486. 
37. 
Hopton AK, Thomas KJ, MacPherson H. Willingness to try acupuncture 
again: reports from patients on their treatment reactions in a low back pain 
trial. Acupunct Med. 2010;28(4):185-188. 
38. 
Jensen TSC, J.; Evans, MA, et al. National Coverage Determination for 
Acupuncture for Chronic Low Back Pain. In: Coverage and Analysis Group 
CfMMS, ed: US Government, CMS; 2020. 
39. 
Rhee TG, Marottoli RA, Van Ness PH, Tinetti ME. Patterns and perceived 
benefits of utilizing seven major complementary health approaches in U.S. 
older adults. J Gerontol A Biol Sci Med Sci. 2018;73(8):1119-1124. 
40. 
Ratcliffe J, Thomas KJ, MacPherson H, Brazier J. A randomised controlled 
trial of acupuncture care for persistent low back pain: cost effectiveness 
analysis. BMJ. 2006 Sep 23;333(7569):626. 
41. 
Cherkin DC, Sherman KJ, Kahn J, et al. A comparison of the effects of 2 
types of massage and usual care on chronic low back pain: a randomized, 
controlled trial. Ann Intern Med. 2011;155(1):1-9. 
42. 
Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB. Is acupuncture 
effective for the treatment of chronic pain? A systematic review. Pain. 
2000;86(3.):217-225. 
43. 
Sherman KJ, Cherkin DC, Deyo RA, et al. The diagnosis and treatment of 
chronic back pain by acupuncturists, chiropractors, and massage 
therapists. Clin J Pain. 2006;22(3):227-234. 
44. 
Nielsen A, Anderson B, Citkovitz C, et al. Developing and employing a 
'responsive manualization' in the 'Acupuncture Approaches to Decrease 
Disparities in Outcomes of Pain Treatment' comparative effectiveness 
study. Acupunct Med. 2019;37(3):184-191. 
45. 
Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in patients with chronic 
low back pain: a randomized controlled trial. Arch Intern Med. 2006 Feb 
27;166(4):450-457. 

 
57 of 61 
Version 1.9 
 
January 2024 
46. 
Grant DJ, Bishop-Miller J, Winchester DM, Anderson M, Faulkner S. A 
randomized comparative trial of acupuncture versus transcutaneous 
electrical nerve stimulation for chronic back pain in the elderly. Pain. 
1999;82(1):9-13. 
47. 
MacPherson H, Thorpe L, Thomas K, Campbell M. Acupuncture for low 
back pain: traditional diagnosis and treatment of 148 patients in a clinical 
trial. Complement Ther Med. 2004;12(1):38-44. 
48. 
Sherman KJ, Cherkin DC, Hogeboom CJ. The diagnosis and treatment of 
patients with chronic low-back pain by traditional Chinese medical 
acupuncturists. J Altern Complement Med. 2001;7(6):641-650. 
49. 
Carlsson CP, Sjolund BH. Acupuncture for chronic low back pain: a 
randomized placebo-controlled study with long-term follow-up. Clin J Pain. 
2001;17(4):296-305. 
50. 
Comachio J, Oliveira Magalhaes M, Nogueira Burke T, et al. Efficacy of 
acupuncture and electroacupuncture in patients with nonspecific low back 
pain: study protocol for a randomized controlled trial. Trials. 2015;16:469. 
51. 
Kerr DP, Walsh DM, Baxter D. Acupuncture in the management of chronic 
low back pain: a blinded randomized controlled trial. Clin J Pain. 
2003;19(6):364-370. 
52. 
Kong JT, MacIsaac B, Cogan R, et al. Central mechanisms of real and sham 
electroacupuncture in the treatment of chronic low back pain: study 
protocol for a randomized, placebo-controlled clinical trial. Trials. 
2018;19(1):685. 
53. 
Fan AY, Ouyang H, Qian X, et al. Discussions on real-world acupuncture 
treatments for chronic low-back pain in older adults. J Integr Med. 
2019;17(2):71-76. 
54. 
MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for 
Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): 
extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. 
55. 
Sherman KJ, Hogeboom CJ, Cherkin DC. How traditinal Chinese medicine 
acupuncturists would diagnose and treat chronic low back pain: results of 
a survey of licensed acupuncturists in Washington State. Complement Ther 
Med. 2001;9:146-153. 
56. 
Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. 
Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the 
knee: a randomized, controlled trial. Ann Intern Med. 2004;141(12):901-910. 
57. 
DeBar LL, Elder C, Ritenbaugh C, et al. Acupuncture and chiropractic care 
for chronic pain in an integrated health plan: a mixed methods study. BMC 
Complement Altern Med. 2011;11:118. 
58. 
Sherman KJ, Cherkin DC, Eisenberg DM, Erro J, Hrbek A, Deyo RA. The 
practice of acupuncture: who are the providers and what do they do? Ann 
Fam Med. 2005;3(2):151-158. 
59. 
Working Group on Health Outcomes for Older Persons with Multiple 
Chronic Conditions. Universal health outcome measures for older persons 
with multiple chronic conditions. J Am Geriatr Soc. 2012;60(12):2333-2341. 

 
58 of 61 
Version 1.9 
 
January 2024 
60. 
Deyo RA, Dworkin RH, Amtmann D, et al. Report of the Task Force on 
Research Standards for Chronic Low-Back Pain. NIH;2013. 
61. 
Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic 
pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1-2):9-19. 
62. 
Jones SM, Lange J, Turner J, et al. Development and Validation of the 
EXPECT Questionnaire: Assessing Patient Expectations of Outcomes of 
Complementary and Alternative Medicine Treatments for Chronic Pain. J 
Altern Complement Med. 2016;22(11):936-946. 
63. 
Coleman BC, Kean J, Brandt CA, Peduzzi P, Kerns RD. Adapting to 
disruption of research during the COVID-19 pandemic while testing 
nonpharmacological approaches to pain management. Transl Behav Med. 
2020;10(4):827-834. 
64. 
Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the 
Oswestry Disability Questionnaire. Spine. 2000;25(24):3115-3124. 
65. 
Williams K, Abildso C, Steinberg L, et al. Evaluation of the effectiveness 
and efficacy of iyengar yoga therapy on chronic low back pain. Spine (Phila 
Pa 1976). 2009;34(19):2066-2076. 
66. 
Vlaeyen JW, Morley S. Cognitive-behavioral treatments for chronic pain: 
what works for whom? Clin J Pain. 2005;21(1):1-8. 
67. 
Cook AJ, Brawer PA, Vowles KE. The fear-avoidance model of chronic 
pain: validation and age analysis using structural equation modeling. Pain. 
2006;121(3):195-206. 
68. 
Goldsmith ES, Taylor BC, Greer N, et al. Focused Evidence Review: 
Psychometric Properties of Patient-Reported Outcome Measures for 
Chronic Musculoskeletal Pain. J Gen Intern Med. 2018;33(Suppl 1):61-70. 
69. 
Chapman JR, Norvell DC, Hermsmeyer JT, et al. Evaluating common 
outcomes for measuring treatment success for chronic low back pain. 
Spine (Phila Pa 1976). 2011;36(21 Suppl):S54-68. 
70. 
Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back 
pain: a joint clinical practice guideline from the American College of 
Physicians and the American Pain Society. Ann Intern Med. 
2007;147(7):478-491. 
71. 
Bombardier C, Hayden J, Beaton DE. Minimal clinically important 
difference. Low back pain: outcome measures. J Rheumatol. 
2001;28(2):431-438. 
72. 
Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain 
and functional status in low back pain: towards international consensus 
regarding minimal important change. Spine. 2008;33(1):90-94. 
73. 
Deyo RA, Dworkin SF, Amtmann D, et al. Report of the NIH Task Force on 
research standards for chronic low back pain. Phys Ther. 2015;95(2):e1-
e18. 
74. 
Farrar JT, Young JP, Jr., LaMoreaux L, Werth JL, Poole RM. Clinical 
importance of changes in chronic pain intensity measured on an 11-point 
numerical pain rating scale. Pain. 2001;94(2):149-158. 

 
59 of 61 
Version 1.9 
 
January 2024 
75. 
Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of 
the PEG, a three-item scale assessing pain intensity and interference. J 
Gen Intern Med. 2009;24(6):733-738. 
76. 
Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes 
Measurement Information System (PROMIS) developed and tested its first 
wave of adult self-reported health outcome item banks: 2005-2008. J Clin 
Epidemiol. 2010;63(11):1179-1194. 
77. 
Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS 
and assessment center to deliver patient-reported outcome measures in 
clinical research. J Appl Meas. 2010;11(3):304-314. 
78. 
Deyo RA, Katrina R, Buckley DI, et al. Performance of a Patient Reported 
Outcomes Measurement Information System (PROMIS) Short Form in Older 
Adults with Chronic Musculoskeletal Pain. Pain Med. 2016;17(2):314-324. 
79. 
Huang W, Rose AJ, Bayliss E, et al. Adapting summary scores for the 
PROMIS-29 v2.0 for use among older adults with multiple chronic 
conditions. Qual Life Res. 2019;28(1):199-210. 
80. 
Cella D, Choi SW, Condon DM, et al. PROMIS((R)) Adult Health Profiles: 
Efficient Short-Form Measures of Seven Health Domains. Value Health. 
2019;22(5):537-544. 
81. 
Segawa E, Schalet B, Cella D. A comparison of computer adaptive tests 
(CATs) and short forms in terms of accuracy and number of items 
administrated using PROMIS profile. Qual Life Res. 2019. 
82. 
Chen CX, Kroenke K, Stump T, et al. Comparative Responsiveness of the 
PROMIS Pain Interference Short Forms With Legacy Pain Measures: 
Results From Three Randomized Clinical Trials. J Pain. 2019;20(6):664-675. 
83. 
Chen CX, Kroenke K, Stump TE, et al. Estimating minimally important 
differences for the PROMIS pain interference scales: results from 3 
randomized clinical trials. Pain. 2018;159(4):775-782. 
84. 
Chiarotto A, Roorda LD, Crins MH, Boers M, Ostelo RW, Terwee CB. 
PROMIS Physical Function short forms display item- and scale-level 
characteristics at least as good as the Roland Morris Disability 
Questionnaire in patients with chronic low back pain. Arch Phys Med 
Rehabil. 2019. 
85. 
Full KM, Malhotra A, Crist K, Moran K, Kerr J. Assessing psychometric 
properties of the PROMIS Sleep Disturbance Scale in older adults in 
independent-living and continuing care retirement communities. Sleep 
Health. 2019;5(1):18-22. 
86. 
Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale 
for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613-
621. 
87. 
Choi SW, Schalet B, Cook KF, Cella D. Establishing a common metric for 
depressive symptoms: linking the BDI-II, CES-D, and PHQ-9 to PROMIS 
depression. Psychol Assess. 2014;26(2):513-527. 
88. 
Schalet BD, Cook KF, Choi SW, Cella D. Establishing a common metric for 
self-reported anxiety: linking the MASQ, PANAS, and GAD-7 to PROMIS 
Anxiety. J Anxiety Disord. 2014;28(1):88-96. 

 
60 of 61 
Version 1.9 
 
January 2024 
89. 
Von Korff M, DeBar LL, Krebs EE, Kerns RD, Deyo RA, Keefe FJ. Graded 
chronic pain scale revised: mild, bothersome, and high impact chronic 
pain. Pain. 2019. 
90. 
Pickard SL, E; Jiang, R; Pullenayegum, E; Shaw, J; Xie, F; Oppe, F; Boye, 
K; Chapman, R; Gong, C; Balch, A; Busschbach, J. . United States 
Valuation of EQ-5D-5L Health States Using an International Protocol. Value 
Health. 2019;22(8):931-941. 
91. 
Sanders GD, Neumann PJ, Basu A, et al. Recommendations for Conduct, 
Methodological Practices, and Reporting of Cost-effectiveness Analyses: 
Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 
2016;316(10):1093-1103. 
92. 
Stetler CB, Legro MW, Wallace CM, et al. The role of formative evaluation in 
implementation research and the QUERI experience. J Gen Intern Med. 
2006;21 Suppl 2:S1-8. 
93. 
Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of 
evidence-based practice implementation in public service sectors. Adm 
Policy Ment Health. 2011;38(1):4-23. 
94. 
Glasgow RE, Davidson KW, Dobkin PL, Ockene J, Spring B. Practical 
behavioral trials to advance evidence-based behavioral medicine. Ann 
Behav Med. 2006;31(1):5-13. 
95. 
Glasgow RE, McKay HG, Boles SM, Vogt TM. Interactive computer 
technology, behavioral science, and family practice. J Fam Pract. 
1999;48(6):464-470. 
96. 
Elwyn G, O'Connor A, Stacey D, et al. Developing a quality criteria 
framework for patient decision aids: online international Delphi consensus 
process. BMJ. 2006;333(7565):417. 
97. 
Flynn RA, L; Scott, SD. Two Approaches to Focus Group Data Collection 
for Qualitative Health Research: Maximizing Resources and Data Quality. 
Int J Qual Methods. 2018;17:1-9. 
98. 
Tates K, Zwaanswijk M, Otten R, et al. Online focus groups as a tool to 
collect data in hard-to-include populations: examples from paediatric 
oncology. BMC Med Res Methodol. 2009;9:15. 
99. 
Hogeboom CJ, Sherman KJ, Cherkin DC. Variation in diagnosis and 
treatment of chronic low back pain by traditional Chinese medicine 
acupuncturists. Complemen Ther Med. 2001;9:154-166. 
100. Sherman KJ, Cherkin DC, Wellman RD, et al. A randomized trial comparing 
yoga, stretching, and a self-care book for chronic low back pain. Arch 
Intern Med. 2011;171(22):2019-2026. 
101. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear 
models. Biometrika. 1986;73:13-22. 
102. Levin J, Serlin R, Seaman M. A controlled, powerful multiple-comparison 
strategy for several situaitons. Psychological Bulletin. 1994;115:153-159. 
103. Hayter AJ. The Maximum Familywise Error Rate of Fisher's Least 
Significant Difference Test. J Am Stat Assoc. 1986;81(396):1000-1004. 
104. Wang M, Fitzmaurice GM. A simple imputation method for longitudinal 
studies with non-ignorable non-responses. Biom J. 2006;48(2):302-318. 

 
61 of 61 
Version 1.9 
 
January 2024 
105. Witt CM, Vertosick EA, Foster NE, et al. The Effect of Patient 
Characteristics on Acupuncture Treatment Outcomes: An Individual Patient 
Data Meta-Analysis of 20,827 Chronic Pain Patients in Randomized 
Controlled Trials. Clin J Pain. 2019;35(5):428-434. 
106. Drummond MF, Sculpher MJ, Torrance GW, O'Brien B, Stoddart GL. 
Methods for the economic evaluation of health care programmes. Vol Third 
Ed. Oxford: Oxford University Press; 2005. 
107. Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL. 
Methods for the Economic Evaluation of Health Care Programmes. 3rd ed. 
Oxford: Oxford University Press; 2005. 
108. Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based 
cost-effectiveness analysis: the importance of controlling for baseline 
utility. Health Econ. 2005;14(5):487-496. 
109. EuroQol Group. EuroQol:  a new facility for the measurement of health-
related quality of life. Health Policy. 1990;16:199-208. 
110. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the 
curious resilience of the $50,000-per-QALY threshold. New England Journal 
of Medicine. 2014;371(9):796-797. 
111. Efron B, Tibshirani RJ. An Introduction to the Bootstrap. Boca Raton, FL: 
Chapman & Hall/CRC; 1994. 
112. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an 
application of the non‐parametric bootstrap. Statistics in medicine. 
2000;19(23):3219-3236. 
113. Nielsen A. Safety in Acupuncture Therapy: Risks and Harms. 2015; 
https://www.healthyseminars.com/product/safety-acupuncture-therapy-
risk-and-harms. Accessed March 3, 2020. 
114. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated 
guidelines for reporting parallel group randomised trials. Trials. 2010;11:32. 
15. SUPPLEMENTS/APPENDICES 
1. Acupuncture Treatment Protocol with Acupoints 
 
2. Acupuncture Treatment Visit Form 
  
3. Informed Consent Drafts (available on June 30, 2020)