Pilot Phase of Group-based Integrative Pain Management: A Multi-level Approach to Address Intersectional Stigma and Social Isolation in Diverse Primary Care Safety Net Patients With Chronic Pain
Phase: NA
Conditions: Chronic Pain
Sponsor: University of California, San Francisco

 
 
 
PROTOCOL TITLE: 
 
Group-based integrative pain management:  
A pilot factorial randomized trial 
 
NCT number: NCT05906784 
 
Document date: December 4, 2024 
 
 
Principal Investigator:   
 
Maria T. Chao, DrPH, MPA 
Professor of Medicine 
Osher Center for Integrative Health 
University of California, San Francisco 
 
 
Supported by:  
 
NIH HEAL Initiative Advancing Health Equity in Pain Management 
Program, the National Institute for Minority Health and Health Disparities, 
and the National Institute of Neurological Disorders and Stroke of the 
National Institutes of Health 
 
Grant number: R61MD018333 
 
Study Intervention Provided by: Not applicable 
 
Sponsor of IND (IDE): Not applicable 
  

 
1 
TABLE OF CONTENTS 
Page 
STUDY TEAM ROSTER ........................................................................................................... 3 
PRÉCIS ..................................................................................................................................... 4 
1. STUDY OBJECTIVES .............................................................................................................. 5 
1.1 
Primary Objective .......................................................................................................... 5 
1.2 
Secondary Objectives ................................................................................................... 5 
2. BACKGROUND AND RATIONALE ......................................................................................... 5 
3. STUDY DESIGN ....................................................................................................................... 6 
4. STUDY PROCEDURES ........................................................................................................... 7 
4.1 
Inclusion Criteria ........................................................................................................... 7 
4.2 
Exclusion Criteria .......................................................................................................... 7 
4.3 
Study Enrollment Procedures ....................................................................................... 8 
4.4 
Data Collection and Randomization .............................................................................. 8 
5. STUDY INTERVENTIONS ....................................................................................................... 9 
6. STUDY OUTCOMES .............................................................................................................. 11 
6.1 
Feasibility Outcomes ................................................................................................... 11 
6.2 
Patient-reported Outcomes ......................................................................................... 11 
7. SAFETY ASSESSMENTS ..................................................................................................... 12 
7.1 
Specification of Safety Parameters ............................................................................. 12 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ... 12 
7.3 
Adverse Events and Serious Adverse Events ............................................................. 13 
7.4 
Reporting Procedures ................................................................................................. 13 
7.5 
Follow-up for Adverse Events ..................................................................................... 14 
7.6 
Safety Monitoring ........................................................................................................ 14 
8. INTERVENTION DISCONTINUATION .................................................................................. 14 
9. STATISTICAL CONSIDERATIONS ....................................................................................... 15 
9.1 
Sample Size Rationale ................................................................................................ 15 
9.2 
Statistical Analysis Plan .............................................................................................. 15 
10. DATA COLLECTION AND QUALITY ASSURANCE .......................................................... 16 
10.1 
Data Collection Forms ................................................................................................. 16 

 
2 
10.2 
Data Management ....................................................................................................... 17 
10.3 
Quality Assurance ....................................................................................................... 17 
10.3.1 
Training ............................................................................................................... 17 
10.3.2 
Quality Control Committee .................................................................................. 17 
10.3.3 
Protocol Deviations ............................................................................................. 17 
10.3.4 
Monitoring ............................................................................................................ 18 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................. 18 
11.1 
Institutional Review Board (IRB) Review .................................................................... 18 
11.2 
Informed Consent Forms ............................................................................................ 18 
11.3 
Participant Confidentiality ............................................................................................ 18 
11.4 
Study Discontinuation ................................................................................................. 19 
12. REFERENCES ..................................................................................................................... 19 
APPENDIX 
Informed Consent Form - English 
 
  
 
 

 
3 
STUDY TEAM ROSTER  
 
Principal Investigator: 
Maria T. Chao, DrPH, MPA 
 
UCSF Professor of Medicine 
 
Osher Center for Integrative Health 
 
& Division of General Internal Medicine - SFGH 
Mailing Address:  
UCSF Box 1726, San Francisco, CA 94143-1726 
Physical Address:  
1545 Divisadero Street, San Francisco, CA 94115 
Telephone:  
415.353.7749 
Fax:  
415.353.9686 
Email:  
Maria.Chao@ucsf.edu 
 
 
Study Team 
 
Name 
Role 
Email 
Melissa Craven, LAc 
Study Interventionist 
melissacraven01@gmail.com 
Wendy Hartogensis, PhD 
Statistician 
Wendy.Hartogensis@ucsf.edu 
Jhia Jackson 
Predoctoral Research Fellow 
Jhia.Jackson@ucsf.edu 
Sudha Prathikanti, MD  
Co-investigator 
Sudha.Prathikanti@ucsf.edu 
Vadan Ritter, LAc 
Study Interventionist 
vadanhealingarts@yahoo.com 
Nakari Ron, LCSW 
Study Interventionist 
nakariron@gmail.com 
Denise Ruvalcaba 
Clinical Research Coordinator Denise.Ruvalcaba@ucsf.edu 
Naomi Schoenfeld, NP 
Study Interventionist 
naomi.schoenfeld@sfdph.org 
Pamela Swedlow, MD 
Co-investigator 
Pam.Swedlow@sfdph.org 
Ariana Thompson-Lastad, PhD 
Co-investigator 
Ariana.Thompson-Lastad@ucsf.edu 
Jesse Wennik, NP 
Co-investigator 
Jesse.Wennik@sfdph.org 
Folashade Wolfe-Modupe, MD 
Co-investigator 
Folashade.Wolfe-modupe@ucsf.edu 
Julia Wu, MPH 
Project Manager 
Julia.Wu@ucsf.edu 
  

 
4 
PRÉCIS  
Study Title  
Group-based integrative pain management in primary care safety net clinics: A pilot 
factorial randomized trial 
Objectives  
The primary objective of this study is to evaluate the feasibility of key study design 
features for a randomized clinical trial of group-based integrative pain management 
in primary care safety clinics. Parameters of interest are feasibility of randomization 
and retention of participants, and intervention fidelity and adherence. A secondary 
objective of the study is to evaluate assessment procedures in preparation for a 
larger scale 2x2 factorial trial of group acupuncture and integrative group medical 
visits. 
Design and Outcomes   
This is a pilot study using a 2x2 factorial randomized clinical trial design. The pilot 
tests two 12-week group-based models: group acupuncture and integrative group 
medical visits (IGMV). Our primary feasibility outcome is participant randomization, 
measured as the percentage of confirmed eligible patients who are randomized. 
Secondary feasibility outcomes include retention (percentage of participants who 
complete 3-month follow up survey), adherence to intervention, and intervention 
fidelity.  Additional outcomes of interest are patient-reported outcomes that will be 
the primary focus of a larger trial. We will assess quality and variability of data at 
baseline and 3-month follow up for pain-related outcomes. Data will include patient-
reported outcomes, electronic health record data, and qualitative interviews, focus 
groups and observations to assess multilevel individual, interpersonal and 
organizational outcomes. 
Interventions and Duration  
All participants will receive usual care and be randomized to group acupuncture, 
IGMV, both, or waitlist control. Participants randomized to group acupuncture will 
receive 12 weeks of once weekly acupuncture treatments delivered in a group 
setting, which consists of a common space with multiple reclining chairs. Participants 
randomized to integrative group medical visits will receive 12 weeks of once weekly 
group sessions that include psychoeducation on pain topics, movement, mind-body 
skills practice, and facilitated discussion designed for social support.   
Sample Size and Population  
Our target population is patients with chronic pain who receive care in primary care 
safety net clinics. For this pilot, we will recruit and enroll 40 English or Spanish-
speaking adults with chronic pain for ≥3 months receiving care in San Francisco 
Department of Public Health primary care clinics are eligible for the trial.  
 
 

 
5 
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
Our primary objective is to pilot study procedures for a 2x2 randomized factorial trial 
of group acupuncture and integrative group medical visits for chronic pain among 
racially and ethnically diverse patients served by the San Francisco Department of 
Public Health. We will assess study feasibility based on the success of 
randomization of study participants (primary feasibility outcome: percentage 
randomized of confirmed eligible), retention, intervention fidelity, and intervention 
adherence.  
1.2 
Secondary Objectives 
Secondary objectives of the study are to test quality and variability of longitudinal 
data for patient-reported, pain-related outcomes. We will collect data at baseline and 
three-month follow-up. Factorial analysis will be performed to assess differences 
from baseline to three-month follow-up at the margins and inside the table. 
2. BACKGROUND AND RATIONALE 
Clinical guidelines and a growing body of evidence endorse nonpharmacologic 
approaches as first line treatment for pain,1 and as a core part of multimodal chronic 
pain management.2-4 Primary care safety net clinics are a critical resource for the 
publicly insured, uninsured, and underserved, and are uniquely positioned for 
providing care to marginalized populations and addressing disparities.5 However, 
significant barriers impede optimal pain assessment and treatment in primary care 
safety net clinics.  
 
Group-based integrative pain management has emerged as a strategy to address 
time constraints and provide multimodal care in safety net clinics. Group-based 
models improve access by providing care to multiple patients simultaneously. Here, 
we focus on two group models involving clinician-delivered care: integrative group 
medical visits (IGMV) and group acupuncture. Numerous Federally Qualified Health 
Centers serving low income, publicly insured patients have implemented group 
models as a strategy to increase access to complementary and integrative health 
approaches such as nutrition, yoga, and mindfulness.6 These IGMV programs have 
been implemented in geographically disperse locations in Spanish and English, 
documenting feasibility in safety net settings serving diverse health disparities 
populations including low-income people from multiple racial/ethnic backgrounds.6 
Existing IGMV programs share several common features. They are informed by 
clinical experiences, driven by patient-identified needs, and include multiple CIH 
therapies. While promising, a lack of coordinated efforts across programs limits our 
understanding of generalizable best practices for safety net clinics, scalability, and 
potential long-term sustainability. Our study addresses this gap during the R61 
phase by manualizing IGMV with national experts.  
 
Acupuncture is an evidence-based treatment for a range of pain conditions,7-9 but it 
is rarely available to safety net patients due to lack of insurance reimbursement.10 
Group acupuncture – a well-established delivery model where multiple patients 
simultaneously receive treatment in a common space, seated in chairs or recliners – 
lowers costs and improves availability,11,12 without compromising patient perceptions 

 
6 
of quality of care.13 In low income primary care patients with chronic neck, back, or 
shoulder pain or osteoarthritis, group acupuncture is associated with decreased pain 
severity, pain interference, and depression based on a quasi-experimental study,14 
and with reduced chronic pain and improved physical function at 12 weeks based on 
a randomized clinical trial.15 Beyond pain relief, group acupuncture is associated with 
improved quality of life, decreased stress, increased engagement in chronic disease 
self-care, 16-18 and reduced barriers to care through ease of scheduling and social 
learning (e.g., less fear of needles seeing others receiving treatment).19 While 
evidence supports use of acupuncture, little is known about the benefits of 
acupuncture co-located in primary care as part of a comprehensive multimodal 
program. Our study addresses this gap by assessing group acupuncture with or 
without IGMV in a factorial trial in primary care safety net clinics. 
3. STUDY DESIGN 
This study is funded through a R61/R33 phased award from the NIH HEAL Initiative. 
The R61 Phase 1 Specific Aims are as follows. In preparation for a larger scale, 
pragmatic 2x2 factorial trial, we aim to: 
1. Refine and manualize IGMV in English and Spanish with stakeholder input and 
informed by relevant theory.  
2. Test randomization procedures, contamination, and intervention fidelity in 40 
patients with chronic pain. 
3. Determine if there is preliminary evidence for our hypothesized mechanisms of 
action on improved pain management. We will collect and analyze data on pain 
outcomes, social isolation, and intersectional stigma. 
 
Here we focus on procedures for specific aim 2, a pilot trial designed to assess the 
feasibility of key study design procedures for a larger trial.  
• 
We will use a 2x2 factorial randomized clinical trial design.   
• 
The primary feasibility outcome for the study is randomization of participants. 
The secondary feasibility outcomes include participant retention, intervention 
fidelity, and intervention adherence. We will also assess degree of bias and 
contamination between study groups. 
• 
We will also assess quality and variability of data on patient-reported pain-
related outcomes. These include is pain interference, social isolation, 
average weekly pain severity, social support for chronic pain, health-related 
quality of life, depressive symptoms, anxiety, sleep disturbance, internalized 
stigma of chronic pain, and pain self-efficacy. 
• 
Study population will consist of adult patients 18 years of age and older who 
have painful diabetic neuropathy and have been seen for their diabetes at 
SFGH clinics within the past year. Forty participants will be enrolled and 
randomized to four arms (10 in each group): (a) usual care, waitlist 
comparison, (b) usual care combined with group acupuncture once weekly, 
(c) usual care with integrative group medical visits, (d) usual care with group 

 
7 
acupuncture and integrative group medical visits. Participants, practitioners, 
and assessors will not be blinded. The statistician will be blinded to 
participant assignment. 
• 
All study procedures will take place at the UCSF Osher Center for Integrative 
Health and at the SFHN Castro Mission Health Center. Recruitment efforts 
will be through the Tom Waddell Urban Health Clinic, Castro Mission Health 
Center, and the Family Health Center.  
• 
The full enrollment period for the study will take place in waves over 2-3 
months depending on the rate of recruitment and the success of enrollment. 
Once the initial 6 participants are enrolled and consented, they will be 
randomized to the three treatment arms (randomization procedures are 
included in Section 4.3). Data collection and treatment will begin for the initial 
6 participants while recruitment and enrollment continue on a rolling basis for 
the remaining study participants. The estimated duration of study involvement 
for each participant is approximately six months, which includes a 12-week 
intervention and a 3-month follow up interview post-intervention.  
• 
Description of intervention and administration: All study participants will 
receive usual care. In addition, some participants will be randomized to 
receive group acupuncture for a period of 12 weeks, once per week. Some 
participants will be randomized to receive integrative group medical visits for 
a period of 12 weeks, once per week.  
4. STUDY PROCEDURES  
Our target population is low-income racially, ethnically, linguistically diverse individuals 
with chronic pain who receive primary care through public safety net clinics. This pilot 
feasibility study will be conducted at the San Francisco Department of Public Health.  
4.1 
Inclusion Criteria 
To enroll in the study, participants must meet all of the following inclusion criteria:  
1. Adults aged 18 years of age or older; 
2. English or Spanish speaking;  
3. Paneled to a primary care provider at one of the clinics of the study;  
4. Diagnosis of chronic pain for 3 months or more;  
5. Had a primary care visit for chronic pain within the past six months;  
6. Ability to provide a phone number; 
7. Intention to be available for up to 24 weeks. 
4.2 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria at baseline will be excluded from 
study participation. 
1. Current anticoagulant use; 

 
8 
2. Active cancer treatment;  
3. Inability to provide informed consent due to mental illness or cognitive 
impairment.  
4.3 
Study Enrollment Procedures  
Screening and Consent 
• 
We will use electronic health records to pre-screen patients who meet key 
eligibility criteria: age, chronic pain diagnosis, primary language, and 
empaneled with primary care provider at a study site. 
• 
We will present a list of pre-screened patients to primary care providers to 
confirm eligibility and approval for enrollment.  
• 
Clinical research coordinators (CRCs) will contact eligible patients by 
telephone to invite them to participate in a study to improve pain 
management in primary care. 
• 
During the telephone call, CRCs will ask eligible patients about their preferred 
method of contact (i.e., phone, text message, and/or email) to schedule an 
orientation session and to receive reminders about the orientation session. 
The study team will also ask eligible patients for permission to send text 
message reminders and whether the study team can leave voicemail 
messages. 
• 
We will also host orientations with eligible patients as an additional 
opportunity for them to learn about the study. 
• 
CRCs will also be available to discuss the study in person with patients who 
are scheduled for upcoming appointments.  
• 
CRCs will obtain informed consent from eligible patients who are interested in 
participating. 
4.4 
Data Collection and Randomization  
• 
Following the consent process, CRCs will conduct a baseline assessment 
with study participants. Baseline data collection will include 
sociodemographic, pain symptoms, mood, daily activities and open-ended 
questions regarding social isolation, stigma, and experiences with pain care. 
• 
After the baseline assessment, participants will be randomized to one of four 
groups (described in more detail below). To maintain participant flow and 
adequate staggering of acupuncture and IGMV, we will use computer-
generated, randomly permuted blocks of 4 and 8, stratified by language. The 
database manager who will not be involved with enrollment will program the 
random allocation sequence; no other study staff will have access to 
generating the randomization sequence. The CRC will access the allocation 

 
9 
sequence using a programmed database that cannot be altered once the 
randomized condition is revealed.   
• 
Participants randomized to study interventions will participate in weekly 
sessions for twelve weeks and those randomized to Integrative Group 
Medical Visits have the option to participate in focus groups immediately 
following the final weekly session.   
• 
Three months after baseline, participants will complete validated surveys 
about pain symptoms, social isolation, quality of life, and other pain-related 
symptoms and open-ended questions about pain management.  
• 
Three months after baseline, participants will also complete semi-structured 
interviews on participants’ experiences living with chronic pain, and their 
perspectives on non-pharmacologic pain treatment, including participation in 
the study.  
• 
Interviews will focus on participants’ experiences treating chronic pain, 
perspectives on non-pharmacologic treatment, and experiences referring 
patients to the Integrative Pain Management Program (i.e., the larger RCT 
component of this study). These interviews will last 45-60 minutes and take 
place in-person or virtually at a private location of the participant’s preference 
(e.g., the participant’s office, UCSF Osher Center for Integrative Health 
offices, or via Zoom). At the time of the interview, participants will complete a 
brief demographic form (including gender, racial and ethnic identity, years of 
clinical experience, and chronic pain treatment experience). No EHR data of 
any kind will be collected for providers participating in the provider interview 
subsample. 
5. STUDY INTERVENTIONS  
Study interventions are based on stakeholder input and patient preference, and the extent that 
they: (1) reflect real world practices that are viable options in primary care safety net settings, 
and (2) could be standardized to enhance replicability in future studies or in clinical practice. 
Study participants will be randomized to one of four experimental conditions:  
 
i. 
Usual care. Participants will receive care as usual provided through their primary 
care providers. Usual care includes medical diagnostic evaluation, analgesic drug 
therapies, recommendations for physical activity, and sometimes referral to specialist 
physicians or physical therapy. Usual care was chosen as a comparison arm for this 
study because it is practical and clinically relevant. One challenge with using a usual 
care arm in a clinical trial is the potential variability in the care provided in clinical 
practices.20 EHR data will be extracted and reviewed to accurately describe usual 
care for study participants.   
 

 
10 
ii. 
Integrative Group Medical Visits for Pain. IGMV will consist of a 12-week program 
that provides education on the biopsychosocial model of pain and multimodal 
treatments; physical movement; mindfulness training; and peer support. Non-
pharmacologic approaches were chosen based on guidelines on chronic pain 
management; feedback of experts, staff, and patients;21 and feasibility with the 
greatest potential to benefit participants. Participants will receive a binder with 
educational materials. Weekly IGMV sessions will be two hours in a group meeting 
space at the clinics. Sessions will start with a “check-in” where participants can share 
their emotions, thoughts, hopes, and fears related to their health and provide 
updates since the last session. Group sessions will be led by a primary care provider 
and a health educator and will include psychosocial support, tools for pain self-
management, and psychoeducation for pain management.22,23 Following the group 
“check-in,” an invited guest (example: pharmacist, mindfulness expert) will provide 
information on 
educational topics, 
including neurobiology 
of pain, medication 
safety, and connections 
between mood and 
pain (see table 1 for 
sample content based 
on prior IGMV), as well 
as participatory 
activities such as 
therapeutic movement 
or mindfulness practice. 
 
iii. 
Group Acupuncture. Acupuncture was selected based on: (1) strength of supporting 
evidence and inclusion in clinical guidelines,8,9,24-26 (2) high acceptability and 
feasibility in our target population as demonstrated in our preliminary studies, and (3) 
substantial access barriers for socioeconomically disadvantaged patients due to lack 
of insurance coverage. Participants randomized to acupuncture will receive 12 
weeks of acupuncture treatments delivered in a group setting, dosing similar to prior 
research.15,16 Acupuncture point selection and other treatment details will follow 
responsive manualization, a protocol developed for the largest RCT of group 
acupuncture to date.15,27 A licensed acupuncturist experienced with administering 
group acupuncture treatments will determine each participant’s traditional Chinese 
medicine diagnosis and administer 8-10 acupuncture needles on distal points of 
participant’s body (below the knees, from the elbows to the hands, and on the head). 
Duration of assessment, needle placement and retention will be 30-45 minutes. 
Details of acupuncture treatments (e.g., frequency and duration, TCM diagnosis, 
number of needles and points used) will be documented in standard EHR charting 
used by the Osher Center for Integrative Health.28  
 
iv. 
Both group acupuncture and IGMV. Along with usual care, participants will be offered 
weekly group acupuncture treatments and integrative group medical visits as 
described above. 
Table 1. Sample IGMV Content  
Week 
Content 
Facilitator(s)* 
1 
Orientation – goals, neurobiology of pain, 
pain stories, treatments & self-care  
Health Educator & Program 
Coordinator (group facilitators) 
3 
Mindfulness, physical movement 
Certified yoga instructor 
4 
Thoughts & pain, medication education  
Clinical Pharmacist 
5 
Stress & pain, meditation/mindfulness 
Mindfulness instructor 
6 
Emotions & pain 
Clinical psychologist 
7 
Self-massage 
Certified massage therapist 
8 
Pacing, physical movement 
Certified yoga instructor 
9 
Nutrition, meditation/mindfulness 
Nutritionist, mindfulness instructor 
10 
Sleep& pain 
Clinical Pharmacist 
11 
Relationships & pain 
Clinical psychologist, educator 
12 
Moving forward, graduation 
Program Coordinator 
* Primary care provider present at all sessions  

 
11 
6. STUDY OUTCOMES 
6.1 
Feasibility Outcomes 
Study feasibility includes multiple parameters. To assess the feasibility of conducting 
a 2x2 factorial trial of group-based integrative pain management in primary care 
safety net clinics, we have chosen key parameters, operational metrics, and goals for 
each metric as shown in Table 1. 
Table 1. Feasibility Parameters, Metrics and Goals  
Feasibility 
Parameter 
Operational Metric 
Goal 
Recruitment 
(primary feasibility 
outcome) 
Percent of confirmed eligible 
patients who are randomized 
40% of confirmed 
eligible patients 
Retention  
Percent of participants who 
completed 3-month follow up 
survey 
80% of randomized 
participants complete 
3-month survey  
Adherence 
Average number of 
intervention sessions attended  
Mean of six 
intervention sessions  
 
6.2 
Patient-reported Outcomes 
Pain-related outcomes of interest include:  
§ Pain interference from baseline to three months, measured using an eight-item survey of the 
NIH Patient Reported Outcomes Measurement Information System (PROMIS).29  Items 
assess the extent that pain interferes with physical, cognitive, emotional, and recreational 
activities. 
§ Social isolation, collected using another NIH PROMIS measure, with an eight-item scale on 
lacking companionship, feeling left out, and feeling isolated.30 
§ We will also assess intervention effects on pain intensity, physical functioning, depression, 
and anxiety using NIH PROMIS measures.31-34  
§ Additional aspects of health-related quality of life associated with chronic pain will be collected 
using NIH PROMIS measures for sleep, social functioning, global physical, mental, and social 
well-being.  
§ Participant ratings of global improvement. A single item, 7 point rating on the Patient Global 
Impression of Change scale will assess minimal clinically important difference in changes in 
participants’ pain.35 
§ Pain beliefs and attitudes will be assessed with scales for pain catastrophizing36 and pain self-
efficacy.37,38 
§ Social Support in Chronic Pain, a 6-item measure of perceived support related to pain.39 
§ Internalized Stigma of Chronic Pain (ISCP) scale, 21 items with five subscales on enacted and 
internalized chronic pain stigma: alienation, stereotype endorsement, discrimination 
experience, social withdrawal, and stigma resistance (Cronbach’s α = 0.724).41 Prior research 
has documented an association between this measure and pain-related cognitive functioning, 
such as pain self-efficacy and pain catastrophizing.41  
§ Intersectional Discrimination Index measures anticipated, day-to-day, and major discrimination 
that do not focus on a single axis of discrimination (e.g., racism, homophobia) to capture 
intersectional categories.42 
§ Descriptive covariates collected at baseline will include: socio-demographic variables (age, 

 
12 
sex, race/ethnicity, place of birth, level of education, household income, marital status, 
employment status, and health insurance status) and a substance use screener (using HEAL 
CDE). Clinical data including chronic pain diagnosis, concomitant conditions, medications, and 
treatments received for pain will be obtained from participants’ medical record. 
§ Use of non-pharmacologic approaches to pain management will also be collected to assess 
access, interest, and satisfaction with multimodal treatments.  
7. SAFETY ASSESSMENTS  
Participant safety will be continually monitored once an individual is enrolled in the 
study. Study staff will complete adverse event reporting on a weekly basis for all 
participants. Potential adverse experiences with group acupuncture include: 
agitation, anxiety, bleeding, bruising, contact dermatitis, dizziness/lightheadedness, 
fatigue, increased pain, redness/infection, soreness of muscles, swelling of 
arm/leg/other, tearfulness, weakness. Most risks associated with acupuncture are 
considered minimal side effects that resolve on their own.  
Depending on the severity of an adverse event, modifications will be made to study 
participation. If an adverse event occurs that affects a participant’s ability to come in 
for study treatments or assessments, study staff will gauge the participant’s 
willingness to continue data collection in alternative ways such as over the phone or 
in-person at their home. If at any point in the study, participants report severe 
depressive symptoms or severe pain, research assistants will be instructed to refer 
participants to their primary care provider. In a situation that requires immediate 
attention, research assistants will notify a healthcare professional to follow-up with 
participants as needed. The medical team will follow standard protocol to ask 
appropriate follow up questions to assess the need for psychiatric evaluation for the 
participant. 
7.1 
Specification of Safety Parameters 
Minor risks associated with acupuncture are anticipated to occur in less than 5% of 
participants. Over the course of the study, which will include 48 patients and a 
maximum of 576 acupuncture treatments, we might expect 5% of patients to have 
minor side effects and do not expect any serious adverse events. Any adverse event 
rate over 5% in 12 months will be reported to the UCSF IRB and NIH/NCCIH.  
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
The safe profile and low risks of acupuncture have been well documented in the 
literature.43-45 A summary of key findings by severity of adverse events is listed 
below: 
• 
Serious adverse events are very rare. Two prospective surveys conducted in 
the United Kingdom, which included over 65,000 acupuncture treatments 
reported no serious adverse events.43,44 A prospective study in Germany of 
229,230 patients who received a total of 2.2 million acupuncture treatments, 
reported two cases of pneumothorax.45  
• 
Minor adverse event rates occur in less than 15 per 10,000 treatments.43,44 
The most common minor adverse events were bleeding or hematoma 
(estimates range from 2.1% to 6.1%), needling pain (< 2%), and aggravation 

 
13 
of symptoms (< 3%).  
• 
Mild transient reactions include feeling relaxed (11.9%) or energized (6.6%), 
tiredness (2.6%), drowsiness (1.1%), dizziness (0.6%), nausea (0.3%), 
feeling faint (0.2%).  
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is defined as any unfavorable and unintended diagnosis, 
symptom, sign (including an abnormal laboratory finding), syndrome or disease 
which either occurs during the study, having been absent at baseline, or if present at 
baseline, appears to worsen. Adverse events will be recorded regardless of their 
relationship to the study intervention.   
A serious adverse event (SAE) is defined as any untoward medical occurrence that 
results in one or more of the following outcomes: 
• 
Death 
• 
A life-threatening event 
• 
Inpatient hospitalization or prolongation of existing hospitalization  
• 
A persistent or significant disability/incapacity 
• 
A congenital anomaly or birth defect 
• 
An important medical event based upon appropriate medical judgment 
Information on minor adverse events will be collected as solicited events. These will 
be listed in alphabetical order on an electronic case report form. Study staff will 
collect this information at participants’ weekly visits. Using an electronic data 
collection system, such as RedCap or Qualtrics, helps to assure that the reporting 
and data collection systems avoid double capture. Describe which AEs will be 
collected as solicited events. The adverse event form will also have items to capture 
any unsolicited events such as serious adverse events; these will be documented by 
study staff without direct input from participants. Adverse events will be reported on a 
monthly basis to the data and safety independent monitor. Serious adverse events 
will be reported immediately.  
7.4 
Reporting Procedures 
As part of training and orientation for the study, all research staff will be alerted to the 
importance and necessity of reporting of all adverse events that occur during the 
study. Forms for adverse event reporting will include sections to document 
relatedness and severity. Any adverse events will be immediately reported to the PI 
(Dr. Chao), dealt with immediately, and if necessary, discussed with mentors and 
advisors. If it is determined that a participant is experiencing a high level of distress, 
the activity will be stopped. Any small or large adverse events will also be discussed 
during weekly research meetings. Registered nurses and medical doctors will be 
available at the SFGH Clinical Research Center (CRC) to supervise and assist with 
procedures. Acute, adverse reactions to acupuncture or any other procedure will be 
treated by a physician. Reporting of adverse events will follow requirements 
mandated by the Committee on Human Research, with concurrent reporting to the 
Research Services Analyst (RSA) at the CRC. In addition, the RSA will receive a 
verbal or e-mail report of any serious adverse event (graded 3 or higher) that occurs 
during the conduct of the study within 48 hours. On-site SAEs and unexpected AEs 
of any grade that are both related to research and result in a change to risk/benefit or 

 
14 
require protocol and consent modifications will be reported to the UCSF IRB within 
10 working days of PI awareness. All other AEs related to the research that are both 
non-serious (grades 1-2) and expected will be reported annually.  
7.5 
Follow-up for Adverse Events 
Any adverse event reported by participants will be followed until resolved or 
considered stable. At subsequent acupuncture treatment visits, study staff will ask 
participants about the status of the reported adverse event at least once or until the 
participant reports that the adverse event has resolved.  
7.6 
Safety Monitoring  
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on 
a daily basis. The full study team will monitor participant symptoms, performance 
status, and review questionnaires and clinical test results. Participants will be 
provided with a 24-hour contact number to report any persistent problems or 
emergencies. If any concerns arise, they will immediately be brought to the attention 
of study PI, Dr. Chao, who will consult with her mentors as needed. The PI will be 
responsible for reporting any adverse events and conducting the annual safety 
review of study data. Study data will be reviewed for adverse events, subject 
complaints, deviations from the protocol design, any unexpected incidents 
associated with the study procedures, and explanations for any subject withdrawals 
from the study. 
8. INTERVENTION DISCONTINUATION  
A subject may be discontinued from study treatment at any time if the subject, the 
investigator, or the Sponsor feels that it is not in the subject’s best interest to 
continue. The following is a list of possible reasons for study treatment 
discontinuation:  
 
Subject withdrawal of consent  
Subject is not compliant with study procedures such as repeatedly not 
completing data collection 
Adverse event that in the opinion of the investigator would be in the best 
interest of the subject to discontinue study treatment 
Protocol violation requiring discontinuation of study treatment 
Lost to follow-up 
Sponsor request for early termination of study 
 
Trained study staff will regularly assess whether participants meet criteria for 
discontinuation at acupuncture treatment visits, data collection visits, and follow-up 
phone calls.  
 
All subjects are free to withdraw from participation at any time, for any reason, 
specified or unspecified, and without prejudice. If a subject is withdrawn from 
treatment due to an adverse event, the subject will be followed and treated by the 
Investigator until the abnormal parameter or symptom has resolved or stabilized.   
 

 
15 
All subjects who discontinue study treatment should come in for an early 
discontinuation visit as soon as possible and then should be encouraged to complete 
all remaining scheduled visits and procedures. 
 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals. The reason for the subject’s withdrawal from the study will be specified 
in the subject’s source documents. Refer to Section 10 for early termination 
procedures. Subjects who withdraw after Week 8 but prior to Week 12 should be 
encouraged to come in for a final visit (and the procedures to be followed would 
include those for their next scheduled visit).   
 
Subjects who withdraw from the study will not be replaced.   
9. STATISTICAL CONSIDERATIONS  
9.1 
Sample Size Rationale  
 
The study will enroll 40 participants. As a small pilot study designed to pilot the refined 
intervention, we did not conduct a formal power calculation but instead used a confidence 
interval approach to determine sample size, based on current recommendations for small 
samples. Findings from the pilot study are intended to help plan for a future trial by estimating 
key parameters. However, small trials often overestimate treatment effects and the convention 
of basing power calculations on pilot trials has received considerable scrutiny (Kraemer, 2006). 
Our approach will be to determine whether the effect size from the pilot is clinically meaningful 
(i.e., within an 80% confidence interval of a pre-determined effect size) and justifies proceeding 
with future research. To determine this, Cocks and Torgenson (2013) recommend that a pilot 
sample size should be at least 9% of the sample size of the planned main study.  
 
Based on data of minimally important differences for PROMIS pain measures, our main study 
would aim to detect a standardized effect size of 0.25. Using our pilot data to estimate within 
group correlation and a sample size calculator designed for individually randomized group trials, 
we estimated a sample size of 360. Using Cocks and Torgenson’s method, the corresponding 
pilot sample size should be at least 32. Using an estimated attrition of 20%, we aim to enroll 40 
participants. With 20 participants randomized to each of the study interventions, we will have 
sufficient power to determine if the effect size estimated from the pilot is within the range of 
clinical significance using a one-sided 80% confidence interval. If the estimated effect is zero or 
less, the upper 80% CI will not contain our target effect size of 0.25, and we would not proceed 
with a main study. If the estimated effect size from the pilot is larger than zero, and the study 
procedures are feasible and acceptable, then we would have sufficient preliminary data to 
proceed with the main study. 
 
9.2 
Statistical Analysis Plan  
Descriptive analyses 
 
Baseline characteristics of participants, including sociodemographics and health condition 
variables, will be summarized to determine sample generalizability, and compared to assess 
group equivalency. We will look at summary statistics for data cleaning (e.g., means, ranges) 

 
16 
and then consider distributions by randomized arm as a check of balanced distribution across 
groups.  
 
Analysis of Feasibility. Feasibility outcomes will be analyzed by computing percentages, with 
95% confidence intervals, of rates of retention and enrollment. We will also conduct a thematic 
analysis of qualitative responses on participants’ experiences with the study and acceptability of 
group acupuncture. 
Assessment of implementation, defined as quality and consistency of the intervention delivery 
across staff, will be focused on evaluating core components and content of IGMV and 
parameters in STRICTA guidelines for group acupuncture. IGMV facilitators will complete a 
short survey after each session documenting content and time spent on each component. 
Acupuncturists will complete charting for each treatment provided.  
Analysis of Patient-Reported Outcome Measures. This study is powered to assess exploratory 
effects and pilot feasibility, not for confirmatory analysis. Nonetheless, we will analyze clinical 
outcomes in a manner similar to that planned for the main study to make a preliminary 
assessment of the strength of the effects; to identify any unexpected issues with missing data, 
skewed distributions, or outliers; and to refine the statistical analysis plan. Relative (mean ± SD) 
measures of effect sizes will be calculated as change from baseline to post-intervention for all 
outcome variables. Planned analyses include: within group changes from baseline to Week 12, 
group acupuncture vs. no acupuncture, and IGMV vs. no IGMV.  
Treatment effects will be estimated using a repeated measures ANCOVA approach.  The 
framework is similar to a linear mixed models but it includes the baseline of the outcome as a 
covariate (and omits the baseline from the outcome vector), and the models will include 
indicators for assignment to acupuncture, IGMV, a categorical variable for time, and interactions 
between treatment indicators and time, as well as random intercepts for person nested within 
group to account for within-group and within-patient correlation of the repeated measures. 
Models with a three-way interaction between the two treatment indicators and time will be 
evaluated as a first step to assess for synergy between IGMV and group acupuncture. We will 
also calculate an interaction ratio to assess clinically meaningful antagonism or synergy 
between the two interventions, specified as interaction ratios of ≤0.80 or ≥1.25.46 If there is 
evidence of interaction, we will assess marginal effects of each intervention. If no evidence of 
synergy is identified, we will proceed with models that omit the three-way interaction term, to 
instead focus on main effects of each treatment type. This approach will optimally weight data 
for patients with different numbers of responses, and will provide valid estimates in the presence 
of missing data under relatively mild assumptions about how the missing data arise.47 We will 
conduct intent-to-treat, per protocol, and complier average causal effects analyses; and 
exploratory as treated analysis (receipt of any group integrative health intervention and dose-
response based on number of sessions attended). Outcomes will be normalized as needed to 
meet model assumptions; for outcomes which do not meet distributional assumptions of 
normality, other generalized linear mixed models or non-parametric approaches such as 
Kruskal-Wallis tests will be used. Secondary outcomes will also be analyzed using this 
approach.   
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 
Data Collection Forms  
The Investigator will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each subject in the 

 
17 
study. Study personnel will enter data from source documents corresponding to a 
subject’s visit into the protocol-specific electronic Case Report Form (eCRF) when 
the information corresponding to that visit is available. Subjects will not be identified 
by name in the study database or on any study documents to be collected by the 
Sponsor (or designee), but will be identified by a subject number. If a correction is 
required for an eCRF, the time and date stamps track the person entering or 
updating eCRF data and creates an electronic audit trail. 
The Investigator is responsible for all information collected on subjects enrolled in 
this study.  All data collected during the course of this study must be reviewed and 
verified for completeness and accuracy by the Investigator.   
10.2 
Data Management 
The data will be entered into a validated database.  The Data Management group will 
be responsible for data processing, in accordance with procedural documentation.  
Database lock will occur once quality assurance procedures have been completed. 
 
All procedures for the handling and analysis of data will be conducted using good 
computing practices meeting FDA guidelines for the handling and analysis of data for 
clinical trials. 
10.3 
Quality Assurance  
10.3.1 Training 
All UCSF Key Personnel conducting human research are required to complete 
human subjects protection training through an online program called 
the Collaborative Institutional Training Initiative (CITI). UCSF Key Personnel are 
defined as all individuals who contribute in a substantive way to the scientific 
development or execution of the study at or on behalf of UCSF. In addition, UCSF 
IRB considers individuals who obtain informed consent to be Key Personnel. The 
CITI course includes an overview of the regulations that govern human subjects 
research, as well as training modules on the Health Insurance Portability and 
Accountability Act as it applies to research. To supplement CITI modules, study staff 
will also receive online training in Good Clinical Practice, Responsible Conduct in 
Research, and more detailed HIPAA privacy and information security training.  
10.3.2 Quality Control Committee  
The quality control committee will consist of Dr. Chao (PI), Dr. Hartogensis (study 
statistician) and Julia Wu (project manager). Ms. Wu will report on metrics described 
in 10.3.3 on a weekly basis with study staff. Dr. Chao, Dr. Hartogensis, and Ms. Wu 
will regularly review quality control reports on a quarterly basis and more frequently 
as needed should any issues or questions arise.  
10.3.3 Protocol Deviations 
At each study encounter, study staff will complete forms documenting adherence and 
deviation with key aspects of the study protocol. The Principal Investigator will review 
the forms on a monthly basis to evaluate any deviations from the study protocol. In 
addition, protocol deviations will be discussed at regularly scheduled study meetings.  
Practitioner adherence to the study manual will also be evaluated by review of 
practitioner clinic notes, observation of clinic visits, and interviews with practitioners 

 
18 
at the completion of each cohort. We will observe three study visits per cohort (i.e., 
monthly over the twelve weeks of acupuncture visits). Deviation from the study 
protocol will be defined as any diagnosis or acupuncture point that is not described in 
the study manual. All deviations will be documented in the Manual of Procedures. 
10.3.4 Monitoring 
After data have been entered into the study database, a system of computerized 
data validation checks will be implemented and applied to the database on a regular 
basis. Queries are entered, tracked, and resolved through the Electronic Data 
Capture system directly. The study database will be updated in accordance with the 
resolved queries.  All changes to the study database will be documented. 
The database is safeguarded against unauthorized access by established security 
procedures; appropriate backup copies of the database and related software files will 
be maintained. Databases are backed up by the database administrator in 
conjunction with any updates or changes to the database. At critical junctures of the 
protocol (e.g., production of interim reports and final reports), data for analysis is 
locked and cleaned per established procedures. 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 
Institutional Review Board (IRB) Review  
All study procedures, informed consent documents, and any subsequent 
modifications will be reviewed and approved by the Institutional Review Board of the 
University of California, San Francisco.  
11.2 
Informed Consent Forms 
A signed consent form will be obtained from each participant. For participants who 
cannot consent for themselves, such as those with a legal guardian (e.g. person with 
power of attorney), this individual must sign the consent form. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A copy will be given to each participant or legal guardian 
and this fact will be documented in the participant’s record. Detailed procedures for 
obtaining consent, including of non-English speakers is described in Section 4.3. The 
informed consent form is attached as Appendix A.   
11.3 
Participant Confidentiality  
In order to maintain confidentiality, any data, specimens, forms, reports, and other 
records that leave the site will be identified only by a participant identification number 
(Participant ID, PID) to maintain confidentiality. Study materials will be marked with 
codes. Only study researchers will have access to the data key that links codes with 
participant names. The data key will be kept in a locked filing drawer in a secure 
office at UCSF accessible only by research staff. At the end of the study, the data 
key will be destroyed. All electronic data collected will be password protected using 
REDCap or a comparable system with a secure, web-based application with features 
to support HIPAA compliance, including a full audit trail, user-based privileges, and 
integration with the institutional LDAP server. Information will not be released without 
written permission of the participant, except as necessary for monitoring by IRB, the 

 
19 
FDA, the NIH, and the OHRP. 
11.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIH, the OHRP, the FDA, 
or other government agencies as part of their duties to ensure that research 
participants are protected.  
12. REFERENCES 
1. 
Qaseem A, Wilt TJ, McLean RM, Forciea MA, Clinical Guidelines Committee of the American 
College of P. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical 
Practice Guideline From the American College of Physicians. Annals of Internal Medicine. Apr 4 
2017;166(7):514-530. doi:10.7326/M16-2367 
2. 
Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for 
Prescribing Opioids for Pain - United States, 2022. MMWR: Recommendations and Reports. Nov 4 
2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1 
3. 
Skelly AC, Chou R, Dettori JR, et al. Noninvasive nonpharmacological treatment for chronic pain: 
A systematic review update. AHRQ Comparative Effectiveness Reviews. Comparative effectiveness 
review no. 227. AHRQ publication no. 20-ehc009. Effective Health Care Program, Agency for Healthcare 
Research and Quality; 2020. Accessed May 7, 2024. 
https://effectivehealthcare.ahrq.gov/products/noninvasive-nonpharm-pain-update/research 
4. 
U.S. Department of Health and Human Services. Pain Management Best Practices Inter-Agency 
Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. 2019. Accessed May 2024. 
https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf 
5. 
Browne AJ, Varcoe CM, Wong ST, et al. Closing the health equity gap: evidence-based 
strategies for primary health care organizations. International Journal for Equity in Health. 2012/10/13 
2012;11(1):59. doi:10.1186/1475-9276-11-59 
6. 
Bruns EB, Befus D, Wismer B, et al. Vulnerable Patients' Psychosocial Experiences in a Group-
Based, Integrative Pain Management Program. J Altern Complement Med. Jul 2019;25(7):719-726. 
doi:10.1089/acm.2019.0074 
7. 
Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for Chronic Pain: Individual Patient Data 
Meta-analysis. Archives of Internal Medicine. Sep 10 2012:1-10. doi:10.1001/archinternmed.2012.3654 
8. 
Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for Chronic Pain: Update of an Individual 
Patient Data Meta-Analysis. Journal of Pain. May 2018;19(5):455-474. doi:10.1016/j.jpain.2017.11.005 
9. 
Giannitrapani KF, Holliday JR, Miake-Lye IM, Hempel S, Taylor SL. Synthesizing the Strength of 
the Evidence of Complementary and Integrative Health Therapies for Pain. Pain Medicine. Sep 1 
2019;20(9):1831-1840. doi:10.1093/pm/pnz068 
10. 
Zhang Y, Lao L, Chen H, Ceballos R. Acupuncture Use among American Adults: What 
Acupuncture Practitioners Can Learn from National Health Interview Survey 2007? Evidence-Based 
Complementary and Alternative Medicine. 2012;2012:710750. doi:10.1155/2012/710750 
11. 
Rohleder L. The Remedy: Integrating Acupuncture into American Health Care. Working Class 
Acupuncture; 2006. 
12. 
Chao MT, Tippens KM, Connelly E. Utilization of group-based, community acupuncture clinics: a 
comparative study with a nationally representative sample of acupuncture users. Journal of Alternative 
and Complementary Medicine. Jun 2012;18(6):561-6. doi:10.1089/acm.2011.0128 
13. 
Tippens KM, Chao MT, Connelly E, Locke A. Patient perspectives on care received at community 
acupuncture clinics: a qualitative thematic analysis. BMC Complementary and Alternative Medicine. Oct 
29 2013;13(1):293. doi:10.1186/1472-6882-13-293 
14. 
Kligler B, Nielsen A, Kohrherr C, et al. Acupuncture Therapy in a Group Setting for Chronic Pain. 
Pain Medicine. Feb 1 2018;19(2):393-403. doi:10.1093/pm/pnx134 
15. 
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;doi:10.1007/s11606-019-05583-6 

 
20 
16. 
Chao MT, Schillinger D, Nguyen U, et al. A Randomized Clinical Trial of Group Acupuncture for 
Painful Diabetic Neuropathy Among Diverse Safety Net Patients. Pain Med. Nov 1 2019;20(11):2292-
2302. doi:10.1093/pm/pnz117 
17. 
Liu R, Santana T, Schillinger D, Hecht FM, Chao MT. "It Gave Me Hope" Experiences of Diverse 
Safety Net Patients in a Group Acupuncture Intervention for Painful Diabetic Neuropathy. Health Equity. 
2020;4(1):225-231. doi:10.1089/heq.2020.0004 
18. 
Kligler B, Buonora M, Gabison J, Jacobs E, Karasz A, McKee MD. "I Felt Like It Was God's 
Hands Putting the Needles In": A Qualitative Analysis of the Experience of Acupuncture for Chronic Pain 
in a Low-Income, Ethnically Diverse, and Medically Underserved Patient Population. Journal of 
Alternative and Complementary Medicine. Nov 2015;21(11):713-9. doi:10.1089/acm.2014.0376 
19. 
Chuang E, Hashai N, Buonora M, Gabison J, Kligler B, McKee MD. "It's Better in a Group 
Anyway": Patient Experiences of Group and Individual Acupuncture. Journal of Alternative and 
Complementary Medicine. Apr 2018;24(4):336-342. doi:10.1089/acm.2017.0262 
20. 
Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering usual 
medical care in clinical trial design. Research Support, N.I.H., Extramural. PLoS medicine. Sep 
2009;6(9):e1000111. doi:10.1371/journal.pmed.1000111 
21. 
Hurstak E, Chao MT, Leonoudakis-Watts K, Pace J, Walcer B, Wismer B. Design, 
Implementation, and Evaluation of an Integrative Pain Management Program in a Primary Care Safety-
Net Clinic. J Altern Complement Med. Mar 2019;25(S1):S78-S85. doi:10.1089/acm.2018.0398 
22. 
Institute of Medicine Committee on Advancing Pain Research CaE. National Pain Strategy 
Report: A Comprehensive Population Health-Level Strategy for Pain. 2016. Accessed November 30, 
2021. https://www.iprcc.nih.gov/national-pain-strategy-overview/national-pain-strategy-report 
23. 
Sharpe L, Jones E, Ashton-James CE, Nicholas MK, Refshauge K. Necessary components of 
psychological treatment in pain management programs: A Delphi study. European Journal of Pain 
(London, England). Jul 2020;24(6):1160-1168. doi:10.1002/ejp.1561 
24. 
Institute of Medicine. National Pain Strategy Report: A Comprehensive Population Health-Level 
Strategy for Pain. 2016. Accessed May 2024. https://www.iprcc.nih.gov/national-pain-strategy-
overview/national-pain-strategy-report 
25. 
Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--
United States, 2016. JAMA. Apr 19 2016;315(15):1624-45. doi:10.1001/jama.2016.1464 
26. 
U.S. Department of Health and Human Services. Pain Management Best Practices Inter-Agency 
Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. . 2019. May 2019. 
Accessed December 1, 2021. https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html   
27. 
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. Acupuncture in Medicine. Jun 2019;37(3):184-191. doi:10.1177/0964528419834015 
28. 
Ye H, Bowden D, Ashby J, Toveg M, Reddy S, Chao MT. Improving usability of electronic health 
records for whole systems integrative medicine practitioners. Journal of Alternative and Complementary 
Medicine. Mar 2019;25(S1):S17-S18. doi:10.1089/acm.2018.0399 
29. 
Amtmann D, Cook KF, Jensen MP, et al. Development of a PROMIS item bank to measure pain 
interference. Research Support, N.I.H., Extramural 
Validation Studies. Pain. Jul 2010;150(1):173-82. doi:10.1016/j.pain.2010.04.025 
30. 
Hahn EA, DeWalt DA, Bode RK, et al. New English and Spanish social health measures will 
facilitate evaluating health determinants. Health Psychology. May 2014;33(5):490-9. 
doi:10.1037/hea0000055 
31. 
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. Nov 2010;63(11):1179-94. doi:10.1016/j.jclinepi.2010.04.011 
32. 
Pilkonis PA, Choi SW, Reise SP, et al. Item banks for measuring emotional distress from the 
Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and 
anger. Assessment. Sep 2011;18(3):263-83. doi:10.1177/1073191111411667 
33. 
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental 
health summary scores from the patient-reported outcomes measurement information system (PROMIS) 
global items. Qual Life Res. Sep 2009;18(7):873-80. doi:10.1007/s11136-009-9496-9 
34. 
Revicki DA, Chen WH, Harnam N, et al. Development and psychometric analysis of the PROMIS 
pain behavior item bank. Research Support, N.I.H., Extramural 

 
21 
Research Support, Non-U.S. Gov't 
Validation Studies. Pain. Nov 2009;146(1-2):158-69. doi:10.1016/j.pain.2009.07.029 
35. 
ECDEU assessment manual for psychopharmacology (DHEW Publication No. ADM 76–338). 
Washington, DC (US Government Printing Office) (1976). 
36. 
Sullivan MJL, Bishop S, Pivik J. The pain catastrophizing scale: Development and validation. 
Psychological Assessment. 1995;7:524-532.  
37. 
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. Feb 
2007;11(2):153-63. doi:10.1016/j.ejpain.2005.12.008 
38. 
Chiarotto A, Vanti C, Cedraschi C, et al. Responsiveness and Minimal Important Change of the 
Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. Jun 
2016;17(6):707-18. doi:10.1016/j.jpain.2016.02.012 
39. 
Van Der Lugt CM, Rollman A, Naeije M, Lobbezoo F, Visscher CM. Social support in chronic 
pain: development and preliminary psychometric assessment of a new instrument. J Oral Rehabil. Apr 
2012;39(4):270-6. doi:10.1111/j.1365-2842.2011.02269.x 
40. 
Malone GP, Pillow DR, Osman A. The General Belongingness Scale (GBS): Assessing achieved 
belongingness. Personality and Individual Differences. 2012;52(3):311-316.  
41. 
Waugh OC, Byrne DG, Nicholas MK. Internalized stigma in people living with chronic pain. The 
Journal of Pain. 2014;15(5):550. e1-550. e10.  
42. 
Scheim AI, Bauer GR. The Intersectional Discrimination Index: Development and validation of 
measures of self-reported enacted and anticipated discrimination for intercategorical analysis. Soc Sci 
Med. Apr 2019;226:225-235. doi:10.1016/j.socscimed.2018.12.016 
43. 
MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: prospective 
survey of 34 000 treatments by traditional acupuncturists. BMJ. Sep 1 2001;323(7311):486-7.  
44. 
White A, Hayhoe S, Hart A, Ernst E. Adverse events following acupuncture: prospective survey of 
32 000 consultations with doctors and physiotherapists. British Medical Journal. Sep 1 
2001;323(7311):485-6.  
45. 
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. Research 
Support, Non-U.S. Gov't. Forschende Komplementarmedizin. Apr 2009;16(2):91-7. 
doi:10.1159/000209315 
46. 
McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a 
systematic review. JAMA. May 21 2003;289(19):2545-53. doi:10.1001/jama.289.19.2545 
47. 
Laird NM. Missing data in longitudinal studies. Statistics in Medicine. Jan-Feb 1988;7(1-2):305-
15. doi:10.1002/sim.4780070131 
 

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PAGE 1 OF 7
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: Group-based Integrative Pain Management 
Principal Investigator:
Maria Chao, DrPH, MPA, Associate Professor, Medicine
1545 Divisadero Street   San Francisco CA 94115
Phone:  415-353-7749; e-mail:  maria.chao@ucsf.edu
Study Coordinator:
Denise Ruvalcaba, Phone: 415-514-0577
Denise.Ruvalcaba@ucsf.edu 
This is a clinical research study. The Principal Investigator, who is the person in charge of this 
study, or a member of the study team from the UCSF Osher Center for Integrative Health will 
explain the study to you.
Research studies include only people who choose to take part.  Please take your time to make 
your decision about participating.  You may discuss your decision with your family and friends 
and with your health care team.  If you have any questions, you may ask the study coordinator.
You are being asked to take part in this study because you have chronic pain.
Why is this study being done?
The purpose of this study is to understand what kinds of healthcare work best for people living 
with chronic pain. This study will compare the effects, good and/or bad, of group pain 
management, group acupuncture, and usual care for chronic pain. We want to see if adding non-
medication treatments to usual care is better than usual care alone for patients with chronic pain. 
In this study, you will be randomly assigned to either A) usual care for chronic pain, B) group 
acupuncture, C) group pain management, or D) group acupuncture and group pain management.
The National Institutes of Health pays for the conduct of this study. 
What is the usual care for my condition?
The usual care for your condition includes pain medications, surgical procedures, and sometimes 
physical therapy or other non-medication treatment options.
How many people will take part in this study?
About 400 people will take part in this study. This includes 40 people in a pilot phase and then 
360 people in a larger study. This consent is for the pilot phase with 40 people.  
What will happen if I take part in this research study?
If you agree, the following procedures will occur: 
-30/3		
-322316  

IPMP+
PAGE 2 OF 7

Baseline Visit. If you choose to participate you will sign this consent form. After you have 
signed the consent form, you will be asked to participate in an initial interview and complete 
forms about your chronic pain symptoms, mood, and daily activities. It should take about 60 
minutes to complete these forms. 

Medical Record Review. Study staff will access your medical record to collect information 
on your health and your use of healthcare services and medication. You will be asked to sign 
a separate form authorizing access, use, creation, or disclosure of health information about 
you.

You will be “randomized” into one of the study groups described below.  Randomization 
means that you are put into a study arm by chance.  A computer program will place you in 
one of the arms.  Neither you nor your primary care provider can choose the arm you will be 
in.  You will have an equal chance of being placed in any arm. If you are in Arm B, C, or D, 
the group programs will include discussions of confidentiality and privacy to support 
comfortable participation: 

If you are in Arm A, you will receive usual care for chronic pain from your primary care 
provider. You will have the option of being on a waiting list to participate in group 
acupuncture or group pain management 3 months after starting the study.

If you are in Arm B, you will participate in weekly acupuncture treatment for 12 
weeks. Acupuncture treatments will take place in a group setting with 6-8 other patients, 
in a common space with multiple reclining chairs located at the clinic. A licensed 
acupuncturist will perform a brief interview with you about your symptoms. The 
acupuncturist will then place thin, sterile acupuncture needles in certain points of your 
body in accordance with traditional Chinese medicine principles. You will then relax 
with needles in place for 20-40 minutes in a quiet, communal space. 

If you are in Arm C, you will participate in a weekly, 2-hour group pain 
management program for 12 weeks. The pain management group will include 8-12 
other patients living with chronic pain. include education about chronic pain; physical 
movement; mindfulness practice; peer support. Group sessions will meet at either Tom 
Waddell Urban Health Clinic or at San Francisco General Hospital. They will be 
facilitated by clinic staff. 

If you are in Arm D, you will participate in both group acupuncture and group pain 
management as described above, each once a week for 12 weeks.  

Follow-up Visit: After 12 weeks, you will be asked to complete a brief interview with a 
study staff member and complete forms about your chronic pain symptoms, mood, and daily 
activities. This visit should take up to 60 minutes. If you are randomized to group pain 
management, you will be invited to participate in a two-hour focus group discussion about 
your experiences with the program. 
Study location: All acupuncture, group pain management and usual care visits will take place at 
the Castro-Mission Health Center, the Tom Waddell Health Clinic or the Family Health Center 
at San Francisco General Hospital. Visits with the study staff will take place at these clinics or if 
you prefer can be done via Zoom videoconference. 
For in person visits for this study, you will first complete COVID-19 screening procedures. 
Study activities will follow UCSF institutional policies for COVID-19, including guidelines for 
masking, social distancing, and population distancing.
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Study Plan
Another way to find out what will happen to you during the study is to read the chart below. Start 
reading at the top and read down the list, following the lines and arrows.
How long will I be in the study?
You will be asked to participate in the study for a total of 3 months. Your total time participating 
in the study will depend on the study arm you are assigned to: about 2 hours if you are in Arm A 
(usual care), about 10 hours if you are in Arm B (group acupuncture), about 28 hours if you are 
in Arm C (group pain management), and about 36 hours if you are in group D (group 
acupuncture and group pain management).
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study staff and your primary care provider if 
you are thinking about stopping or decide to stop. They will tell you how to stop your 
participation safely. It is important to tell your primary care provider that you are thinking about 
stopping to discuss what follow-up care could be most helpful for you.
If you withdraw from the study, any data we have already collected from you will remain part of 
the study records. After you withdraw, the researchers may still get information from your 
medical records if it is relevant to the study. You must tell the study team you do not want this 
information to be collected when you withdraw, otherwise it will be collected. 
The study team may stop you from taking part in this study at any time if they believe it is in 
your best interest, if you do not follow the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the study?
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There are some possible risks from taking part in this study. You may have side effects while on 
the study depending on which group you are in. Everyone taking part in the study will be 
watched carefully for any side effects. However, doctors don’t know all the side effects that may 
happen.  Side effects may be mild or very serious. You should talk to the study staff about any 
side effects you experience while taking part in the study.
Risks and side effects related to the study include:

Randomization risks:  You will be assigned to a treatment group by chance, and the 
treatment you receive may prove to be less effective or to have more side effects than the 
other study treatment(s) or other available treatments.

Some of the questions on the forms or interviews may make you uncomfortable or upset. 
You are free to decline to answer any questions you do not wish to answer. 

Risks to privacy: Participating in group sessions comes with a risk of potential loss of 
privacy from receiving treatment with other people present. All group participants will 
agree with maintaining other people’s medical and personal information completely 
confidential and participants will only share information with others that they choose to 
share. However, confidentiality cannot be guaranteed.

Unknown Risks: There may be side effects that no one knows about yet.  The 
researchers will let you know if they learn anything that might make you change your 
mind about participating in the study.

Risks and side effects related to acupuncture include those which are:
o
Likely

A slight pinch, tingling, or numbness at the site of needle insertion

Sensation of feeling sleepy or relaxed
o
Less Likely 

Bleeding or hematoma (6% of patients)

Slight pain at site of needle insertion (< 2% of patients)

Sweating, dizziness, nausea, or fainting (< 1% of patients)
o
Rare but serious

Pneumothorax and systemic infection have been reported in the literature 
but are very rare (less than 1 out of 10,000).
Are there benefits to taking part in the study?
You may or may not benefit from participating in the study.
What other choices do I have if I do not take part in this study?
Your other choices may include:

Getting treatment or care for your pain without being in a study. 

Taking part in another study.

Getting no treatment.
Please talk to your primary care provider about your choices before deciding if you will take part 
in this study.
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How will my information be used? 
Researchers will use your information to conduct this study. Once the study is done using your 
information, we may use the information collected for future research studies or share them with 
other researchers so they can use them for other studies in the future. We will not share your 
name or any other personal information. We cannot guarantee that this will prevent future 
researchers from determining who you are. We will not ask you for additional permission to 
share this de-identified information.
How will information about me be kept confidential?
Participation in research involves some loss of privacy.  We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total privacy.  Some 
information from your medical records will be collected and used for this study.  Your personal 
information may be given out if required by law.  If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be used.
Authorized representatives from the following organizations may review your research data for 
the purpose of monitoring or managing the conduct of this study:

San Francisco Department of Public Health

Representatives of the National Institutes of Health 

Representatives of the University of California

Representatives of the Office of Human Research Protections (OHRP) 
Are there any costs to me for taking part in this study?
No. The sponsor has agreed to pay for all items associated with this research study; you or your 
insurer will not be billed.
Will I be paid for taking part in this study?
In return for your time and effort, you will be paid for taking part in this study. You will receive 
payment through gift cards or cash. 
You can receive up to $90 for completing interview visits. This includes:

$40 for the baseline visit and $50 for the 12-week follow-up visit 
If you are in an arm receiving group acupuncture or group pain management, you can receive an 
additional $25 for completing all acupuncture or group pain management sessions. 
If you are in an arm receiving group pain management, you can receive $25 for the focus group. 
Will I be reimbursed if I pay expenses related to my participation in this study?
You may be reimbursed up to $25 for parking or transportation if you take part in this study.
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What happens if I am injured because I took part in this study?
It is important that you tell the researcher Dr. Maria Chao, if you feel that you have been injured 
because of taking part in this study. You can tell the researcher in person or call her at 415-353-
7749. 
Treatment and Compensation for Injury: If you are injured as a result of being in this study, the 
University of California will provide necessary medical treatment. The costs of the treatment 
may be billed to you or your insurer just like any other medical costs, or covered by the 
University of California or the study sponsor, the National Institute of Health, depending on a 
number of factors. The University and the study sponsor do not normally provide any other form 
of compensation for injury. For further information about this, you may call the office of the 
Institutional Review Board at 415- 476-1814.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in 
the study. If you decide to take part in this study, you may leave the study at any time. No matter 
what decision you make, there will be no penalty to you, and you will not lose any of your 
regular benefits. Leaving the study will not affect your medical care. You can still get your 
medical care from our institution. 
We will tell you about new information or changes in the study that may affect your health or 
your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek 
payment by signing this form.
Who can answer my questions about the study?
You can contact the research team with any questions, concerns, or complaints you have about 
this study at 415-353-7749.
If you wish to ask questions about the study or your rights as a research participant to someone 
other than the researchers or if you wish to voice any problems or concerns you may have about 
the study, please call the office of the Institutional Review Board at 415-476-1814.   
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results.  You can search this Web site at any time. 
The National Clinical Trial (NCT) number for this study is not yet assigned.
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CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of Rights to 
keep.
You will be asked to sign a separate form authorizing access, use, creation, or disclosure of 
health information about you.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to 
participate or to withdraw at any point in this study without penalty or loss of benefits to which 
you are otherwise entitled.
If you wish to participate in this study, you should sign below.
Date
Participant's Signature for Consent
Date
Person Obtaining Consent
Future contact with this study:
This consent form only covers assessments for the months that you are in the study. If 
you initial this box, you are agreeing to allow researchers to contact you for follow-up 
regarding this study after that time. 
Future contact with other studies:
There may be other research studies at UCSF for which you may be qualified. If you 
initial this box, you are agreeing to allow researchers to contact you to give you   
  information about other studies. 
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