Tai Chi for Chronic Low Back Pain in Older Adults
Phase: NA
Conditions: Back Pain Lower Back Chronic
Sponsor: Kaiser Permanente

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TAI CHI STUDY PROTOCOL 
 
 
R34AT009052 
Tai Chi for Chronic Low Back Pain in Older Adults: A Feasibility Randomized 
Clinical Trial (Back Tai Chi) 
 
 
Karen J Sherman, PhD, Principal Investigator 
Kaiser Permanente Washington Health Research Institute 
Kaiser Permanente Washington  
1730 Minor Avenue, Suite 1600 
Seattle, Washington 98101 
Telephone:  (206) 287-2426 
Fax: (206) 287-2871 
 
 
Sponsored by: 
 
 
OHRP IRB Registration Number: IRB00000668 
OHRP IRB Registration Name:  Kaiser Permanente Washington  
 
July, 20th, 2017 
 
 
 
 
 

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TABLE OF CONTENTS  
 
Precis 
  
4 
1.  Study Objectives 
  
7 
2.  Background and Rationale 
7 
     2.1 Background on Back Pain 
7 
     2.2 Study Rationale 
7 
3.  Study Design 
10 
4. Section and Enrolment of Participants 
11 
4.1  Source of Participants 
11 
            4.2 Inclusion Criteria 
12 
            4.3 Exclusion Criteria   
12 
            4.4 Study Enrollment Procedures 
13 
 5 Study Interventions 
15 
            5.1  Tai Chi  (Standard and Maintenance Protocols,  
                    Intervention Fidelity) 
15 
            5.2 Usual Medical Care 
23 
            5.3 Attention Control 
23 
6. Description of Study Visits and Outcome Measures
24 
6.1  Screening Evaluation 
25 
6.2  Enrollment, Baseline and Randomization
25 
6.3  Blinding 
25 
           6.4  Follow-up Visits 
26 
7. Assessment of Safety 
29 
           7.1  Methods and Timing for Safety Assessment 
29 
           7.2 Adverse Events and Serious Adverse Events 
30 
           7.3 Reporting Procedures 
30 
7.4 Follow up for Adverse Events 
31 
7.5  Safety Monitoring 
31 

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8.  Intervention Discontinuation 
31 
9.  Statistical Considerations 
32 
            9.1  General Design Issues 
 
32 
            9.2  Sample Size and Randomization 
32 
            9.3  Definition of Populations 
33 
            9.4  Interim Analyses and Stopping Rules 
33 
            9.5  Outcomes 
34 
            9.6  Data Analyses (feasibility of RCT; information for full RCT; 
                  Preliminary outcome analyses)   
34 
10. Data Collection, Quality Control, and Confidentiality
36 
10.1  Data Collection Forms 
36 
10.2  Data Management 
36 
10.3  Quality Assurance (training; protocol deviations;         
         monitoring) 
38 
11.  Ethical Principles 
38 
            11.1  Institutional Review Board 
 
38 
            11.3  HIPAA 
38 
            11.4  Confidentiality of Participant Records 
39 
            11.5  Study Discontinuation 
39 
12. Organization and Administration 
39 
12.1  Funding and Organizational Oversight 
39 
12.2  Organizational Structure 
 
39 
13. Publication Policies and Procedures 
40 
14.  Study Timeline: Milestones 
40 
15.  References 
41 
16. Appendix A 
46 
 
 
 
 

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PRECIS 
 
TITLE  
Tai Chi for Chronic Low Back Pain in Older Adults
INVESTIGATORS 
Karen Sherman, PhD, Principal Investigator 
Kaiser 
Permanente 
Washington 
Health 
Research 
Institute, Seattle 
 
 
Elizabeth Phalen, MD Co-Investigator 
University of Washington, Seattle 
 
Manu Thakral, NP, PhD, Co-Investigator 
Kaiser 
Permanente 
Washington 
Health 
Research 
Institute, Seattle 
 
Judith Turner, PhD, Co-Investigator 
University of Washington, Seattle 
STUDY OBJECTIVES 
This study is designed to determine the feasibility of 
conducting a full-scale randomized controlled trial (RCT) 
of Standard Tai Chi, Enhanced Tai Chi, an Attention 
Control and Usual Medical Care for chronic low back 
pain in older adults. In addition, we will consider the 
feasibility of an attention control. By collecting data on 
recruitment and randomization rates, Tai Chi class and 
home practice attendance, rate and severity of adverse 
events and follow-up rates at 12, 26, and 52 weeks as 
well as observations of acceptability of Tai Chi classes 
and adequacy of Tai Chi performed, qualitative 
comments by participants, study staff and the Tai Chi 
instructor as well as the acceptability of the Attention 
Control, we will be able to determine the feasibility of the 
full-scale RCT.
DESIGN AND OUTCOMES
This is a feasibility RCT designed to test whether 
conducting an RCT of Tai Chi versus Attention Control 
versus Usual Medical Care to improve chronic low back 
pain in older adults is realistic. The feasibility of the full-
scale study will be determined by assessing the 
feasibility of recruitment; acceptability and adherence of 
Tai Chi classes and home practice as well as the 
Attention Control; rate and severity of adverse events 
and adequate follow-uprates. Outcome measures for 
studies of back pain, including impact on back-related 
function and pain – primary outcomes for any RCTs of 
back pain, will be collected. 

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POPULATION/SITE 
Persons who are at least 65 years of age, have had at 
least 3 months of non-specific (or degenerative) low back 
pain (and back pain on at least half the days over a 6 
month period), and who rate their pain at least 4 on a 0 
to 10 scale and have a score of at least 3 on a 0 to 10 
Pain Interference Scale. Participants will be recruited 
from Kaiser Permanente Washington, an integrated 
healthcare system in the Puget Sound region of 
Washington State and from the general population of the 
region as necessary. 
INTERVENTIONS 
Participants will be randomized to one of two treatments: 
 Enhanced Tai Chi (TC) 
 Comprehensive Health Education Control 
 Usual Medical Care (UMC) 
INTERVENTION 
SCHEDULE 
Enhanced Tai Chi consists of Standard + Maintenance 
Tai Chi. Standard period: 12 weeks of 2x weekly classes 
of Tai Chi plus daily home practice on non-class days. 
Maintenance period:  24 weeks of maintenance Tai Chi 
(6 weeks of weekly Tai Chi classes; 6 weeks of every 
other week classes; 12 weeks of monthly classes). 
Home practice will be encouraged on all non-class days 
for the entire 52-week follow-up period. Attention Control 
consists of 12 weeks of 2x weekly classes about senior 
health with discussion. All Tai Chi participants have 
access to all care provided by their insurance. 
 
Usual Medical Care: participants are free to make any 
visits to their physicians and other health care providers 
and use other treatments. 
SAMPLE SIZE 
78 participants (39 Tai Chi, 15 Attention Control, 24 
Usual Medical Care) 
RECRUITMENT PERIOD 
Participants will be recruited in 2 cohorts of 38 and 40 
persons.  
STUDY AIMS 
1) To determine the feasibility of recruiting and 
randomizing  older adults with cLBP into a trial of Tai Chi 
versus Attention Control versus Usual Medical Care. 
  
2) To determine whether older adults with cLBP will 
come to classes in the primary 12 week period. To 

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estimate home practice for tai chi (frequency and 
duration during this period). 
 
3) To determine whether older adults with cLBP will 
come to maintenance classes, practice at home and  find 
benefit from other strategies to enhance home practice.  
 
4) To determine the rates of follow-up assessment of 
older adults with cLBP.
FEASIBILITY OUTCOMES 
1) Recruitment yield and period of time to recruit and 
randomize one class cohort. Number of cohorts 
that could be recruited. 
 
2) Class attendance and home practice adherence 
in primary treatment period 
 
3) Class attendance and home practice adherence 
in secondary treatment period 
 
4) Follow-up rates at 12, 26, and 52 weeks for 
outcome assessment. Primary outcome measures 
are back-related dysfunction and pain. 
 
These outcomes will be measured at baseline, 12 weeks 
(at the end of standard classes), 26 (during maintenance 
classes), and 52 weeks.  
SAFETY OUTCOMES 
Any adverse events identified during classes, on the 
follow-up interviews or through other means will be 
documented and reported on a regular basis to the Data 
Safety Monitoring Body (DSMB). Serious adverse events 
will be reported to the DSMB within 7 days. If attributable 
to the interventions, serious adverse events will also be 
reported to the IRB within 7 days.  
MASKING 
All 
persons 
collecting 
outcome 
information 
(i.e., 
assessors) will be masked to each participant’s group 
assignment. 
 
 

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1.  STUDY OBJECTIVES 
This study is designed to determine the feasibility of conducting a full-scale 
randomized controlled trial (RCT) of Standard Tai Chi, Enhanced Tai Chi and Usual 
Medical Care for chronic low back pain in older adults. In the feasibility study, we will 
test our ability to recruit and randomize older adults with chronic low back pain, to 
determine whether the Enhanced Tai Chi intervention is feasible in terms of class 
attendance and home practice, and to determine follow-up rates at 12, 26 and 52 
weeks. 
 
2. BACKGROUND AND RATIONALE  
2.1 Background on Back Pain 
Back pain is the leading cause of disability worldwide, with both prevalence and 
burden increasing with age1, with an estimated 12% of adults over age 65 suffer from 
impairing cLBP.2  In the US, about $86 billion is spent annually on direct costs of 
medical care for back/neck pain3. Escalating costs of care for back pain are particularly 
marked for older Americans. While the Medicare population increased only 42% 
between 1991 and 2002, costs for back pain increased 387%.4  In addition, during a 
recent 12-year period Medicare expenditures for epidural steroid injections increased 
629%, expenditures for opioids for back pain increased 423%, while the number of 
lumbar magnetic resonance images increased 307% and the number of spinal fusion 
surgeries increased 220%.5  Despite these large investments in medical care for back 
pain, the health and functional status of persons suffering from back pain in the U.S. 
has deteriorated.3 Moreover, the rapid projected growth of older adults ensures that  
back pain in older adults will assume an increasingly greater clinical burden in the years 
to come. 
 
Determining the cause of chronic low back pain (cLBP) is often difficult because 
of the numerous structures in the back that can give rise to pain. Moreover, virtually all 
older adults have radiographic evidence of spinal osteoarthritis, even though most are 
asymptomatic.6 Even among older adults with back pain, the severity of their symptoms 
is poorly correlated with the severity of the imaging findings. Moderate to severe spinal 
stenosis is as common in older adults with and without chronic back pain.6 Thus, 
imaging is not a good method to discern the cause of back pain in most circumstances.  
 
2.2 Study Rationale 
Identifying safe and effective treatments for cLBP in older adults remains a major 
challenge for clinicians, researchers, payers, and patients. Clinical guidelines for back 
pain in older adults are not available and many older adults have yet to find adequate 
relief. Older adults commonly have more disabling back pain,7 more comorbidities with 
attendant polypharmacy8 and are at higher risk of adverse effects of commonly used 
medication and non-pharmacological treatments.2,9-11  They have substantially 
increased risks for: 1) gastric bleeding and renal insufficiency from use of NSAID drugs, 
2) falls with use of muscle relaxants (which affect the central nervous system), and 3) 
falls, fractures, and cognitive impairment with use of narcotic analgesics.  Because 
many older adults already take multiple medications for other chronic conditions, using 
medications for back pain increases their risk of drug-drug interactions.  Surgical risks 

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also increase with age.  Safety concerns are not limited to the use of conventional 
medical care.  Even normally low risk complementary and integrative medical 
treatments such as high velocity spinal manipulation techniques may be contraindicated 
for older adults with osteoporosis, compression fractures, and other degenerative 
conditions. This may explain why older adults receive less treatment of any type for their 
back pain, despite reporting similar pain intensity and more disability.12 
  
 
Given the expected aging of the US population in the coming decades, finding 
safer treatments for them is imperative. The 2007 back pain guidelines found 8 
treatments effective for chronic low back pain. 13  These included exercise programs as 
well as three mind body therapies (wherein the mind is used to affect physical function 
and improve health14 -- yoga, cognitive behavioral therapy, and progressive muscle 
relaxation. The most effective exercise programs included supervision of participants 
and encouraged adherence to achieve high dosage.15  Stretching exercises were found 
to be best for reducing pain and muscle strengthening exercises were best for 
improving function. While some mind-body complementary and integrative health 
treatments such as meditation focus primarily on the mind, others including yoga and 
Tai Chi, promote movement as well as mental focus.   
 
Tai Chi, a mind-body exercise from China that has grown in popularity in the  
US,16 looks to be an excellent candidate as a treatment for chronic low back pain in 
older adults. Tai Chi has been found effective for younger adults with chronic low back 
pain.17,18 Both studies measured pain intensity and found improvements, while the Hall 
study also measured back-treatments function and found improvements in it as well.17  
It contains numerous elements that are likely accessible to older adults that may be 
therapeutic. First, Tai Chi features gentle and progressive stretching movements within 
a moderate range of motion. It is likely to be relatively safe because it avoids putting the 
body into full extension or contraction as other exercise and yoga sometimes do.  Of 
roughly 50 RCTs of Tai Chi (mostly of older adults) that monitored adverse effects, none 
reported any severe adverse effects.19 Second, Tai Chi focuses on enhancing the 
body's capacity to integrate core and leg muscles rather than focusing on single muscle 
groups. Third, Tai Chi includes key characteristics of other exercise programs that have 
been found effective for cLBP (i.e., stretching and strengthening exercises delivered in 
supervised programs.20 Fourth, Tai Chi incorporates focused breathing, mindful 
attention, visualization, and other components that are known to be beneficial for 
chronic pain.16 Fifth, Tai Chi classes provide a venue for personal and social connection 
for persons who are socially isolated. Finally, baby boomers, who are now reaching age 
65 in large numbers, have embraced a wide variety of CIM treatments21 and may be 
less enthusiastic about participating in the types of exercise programs popular among 
the preceding generation.   
 
  
In addition, Tai chi appears to have benefits for numerous health concerns and 
conditions22-25 that are more common in the elderly, including balance and falls 
prevention,26,27 cardiorespiratory fitness,28,29 cognitive performance,30 congestive heart 
failure,29,31 bone health,32 and osteoarthritis.33,34  
 

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In summary, we think Tai Chi is an ideal therapy for cLBP in older adults because 
it is safe, promotes active engagement in gentle exercise, includes a variety of 
potentially therapeutic elements, has been found effective for younger adults, and has 
been found helpful for a variety of comorbidities affecting many older adults.  We are 
unaware of studies evaluating Tai Chi in older adults with chronic back pain. However, 
our 2001 survey of older adults with back pain in Seattle35 found that a majority reported 
interest in Tai Chi training if it were offered for free and was recommended by their 
physician.  
 
This study is proposed as a feasibility study comparing an “Enhanced Tai Chi” 
group to “Comprehensive Health Education” to “Usual Medical Care”, which, if 
successful, would pave the way for a full-scale trial to evaluate Tai Chi as a treatment 
for older adults with chronic low back pain. Section 2.2a describes this goal, which is 
important for understanding the context of the feasibility trial, which is further described 
and justified in Section 3. 
 
2.2a.  Long Term Goal of Research 
Our ultimate goal is to conduct an RCT to answer the practical question of whether 
Tai Chi is effective for relieving cLBP in older adults when added to Usual Medical 
Care. Our Standard dose of Tai Chi would be 12-week 2x/weekly series of Tai Chi 
classes (see Section 5 for further details and justification).Because Tai Chi requires 
ongoing practice, maintaining the practice is critical and so we would investigate the 
value of including and Enhanced Tai Chi group that receives Standard Tai Chi plus a 24 
week maintenance period of progressively fewer classes: 6 weeks of weekly classes, 6 
weeks of every other week classes and 12 weeks of monthly classes). All classes would 
be 60 minutes long. Participants would be asked to practice 15 minutes at home on all 
non-class days. The anticipated design of our full-scale trial is depicted on the next 
page (note that Usual Medical Care will be available to all study groups). We are 
unclear regarding the value of an Attention Control, which will be a included in one of 
the cohorts of the feasibility RCT: 
 
Our principal hypotheses would be: 
   H1: Tai Chi is superior to Usual Medical Care at 12, 26, and 52 weeks. (Primary time 
point would be 12 weeks). 
   H2: Enhanced Tai Chi (standard + maintenance) is superior to Standard Tai Chi at 26 
and 52 weeks. (Primary time point would be 52 weeks). 
   H3: Tai Chi is superior to Attention Control at 12, 26, and 52 weeks (assuming we 
include the AC group). (Primary time point would be 12 weeks). 
The primary outcomes would be back-related dysfunction (most critical) and pain.  
 

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Figure: Anticipated Design of Full-scale Trial  
 
3. STUDY DESIGN 
The feasibility study will be a three arm parallel group RCT comparing Enhanced 
Tai Chi to Comprehensive Health Education (Attention Control) to Usual Medical Care 
in older adults (65 years and older) with cLBP. We plan to recruit 78 community-
dwelling, older adults from Kaiser Permanente Washington, an integrated healthcare 
system with a large population of Medicare enrollees and from the general population 
as necessary. We will randomize eligible and willing individuals in a 8:3:5 ratio to 
Enhanced Tai Chi (n=39), Attention Control (n=15) and Usual Medical Care (n=24) 
using a computer with a tamperproof program that is not predictable in advance. 
Participants in the Enhanced Tai Chi will receive 36 weeks of classes (which will be 60 
minute classes for 2x/week for 12 weeks; followed by a maintenance schedule of 60 
minutes classes 1x/week for 6 weeks, then 60 minute classes every 2 weeks for 6 
weeks and then 60 minute classes every 4 weeks for 12 weeks. Participants will be 
asked to practice at home for 15 minutes on every non-class day. They will be provided 
with Youtube video access (and, if desired, DVDs), and handouts to assist with this.). All 
classes will be taught in a Kaiser Permanente Washington classroom. Data on 
adherence to Tai Chi classes and home practice will be collected during the classes 
themselves. Because Tai Chi will be taught as a series of progressive classes, 
participants will be recruited in two cohorts of 32 each; each class of Tai Chi will consist 
of 16 participants.  
 
Outcome assessments will be collected at baseline, 12, 26, and 52 week during 
in-person visits. Outcome assessors will be unaware of any participant’s study groups, 

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but participants will be asked to complete their own questionnaires. They will either 
complete them on paper forms or using a tablet computer designed to minimize errors. 
 
This design will allow us to collect data on recruitment and randomization rates, 
acceptance and feasibility of the Tai Chi intervention (adherence to the standard and 
maintenance Tai Chi protocols), and follow-up rates, which are critical to assess 
feasibility of the full-scale RCT. By including these treatment groups – which represent 
the extremes in time commitment - in the feasibility RCT, we likely to collect data that is 
applicable to the other treatment groups (i.e., standard Tai Chi and Attention Control, if 
the latter is used) included in a full-scale RCT. At the 52 week follow-up, we will also 
obtain information from debriefing discussions with the study participants about aspects 
of the study that would require modification prior to the conduct of a larger RCT. We will 
use the proposed outcome measures and physical measures in their entirety to ensure 
that these are feasible in terms of participant burden. Because the RCT is 
underpowered for effectiveness, it is not appropriate to have specific hypotheses 
regarding effectiveness. Nonetheless, back-related function and pain would be the 
primary outcomes in the full-scale trial as described above.  
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 Source of Participants 
Participants will be recruited from Kaiser Permanente Washington, an integrated 
health care system serving over 400,000 adult members in their primary care clinics in 
Washington State. This includes 67,341 members age 65+, of which over 10,000 made 
medical visits for back pain in 2014.  This should provide an ample number of members 
who have chronic back pain who would be eligible for our study, particularly given our 
2001 survey findings35  that 55% of older adults receiving care from GH reported they 
would be “very likely” to try “Tai Chi” for their back pain if their provider considered it a 
reasonable option and it was free. Furthermore, given the growing popularity of mind-
body therapies in recent years since our 2001 survey,41 interest in Tai Chi has probably 
increased. Recruitment from the GH population will enhance the generalizability of our 
results to the large fraction of Americans that receive most of their medical care in 
primary care settings.  We will augment the Kaiser Permanente Washington population 
as necessary by recruiting from the general Seattle area.  
 
4.2 Inclusion Criteria 
Participants will need to meet all of the inclusion criteria to participate in the study. 
Participants must: 
 Be men or women at least 65 years of age 
 Have low back pain that has persisted for at least three months 
 Have had back pain on at least half the days in the last 6 months 
 Rate their low back pain at least 4 on a 0 to 10 back pain intensity scale 
 Rate their activity limitations due to back pain at least 3 on a 0 to 10 scale  
 Be members of Kaiser Permanente Washington integrative health care system or 
have a regular source of health care and health insurance 
 Have normal cognition or only mild cognitive impairment ( score of <3 on 6 item 
Callahan screener) 

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 Be capable of understanding the study procedures and complying with them for 
the entire study period. 
 Live close enough to the class site for attendance to be practical 
 Give informed consent 
Because there are a number of back pain diagnoses that might be given to eligible 
participants, we will cast a wide net using ICD9 or ICD10 codes that could be indicative 
of back pain without specific cause (i.e., ICD-10 codes: M54.5 Lumbago;M54.9 
Backache; unspecified; M45.0 Other symptoms referable to back; S33.6XXA Sprains 
and strains, sacroiliac; S33.5XXA Sprains and strains, lumbar; S33.8XXA Sprains and 
strains, sacral; and S33.9XXA Sprains/ strains, unspecified site of back) or due to 
degenerative disease. Currently, ICD codes do not indicate whether the pain is chronic 
or not, so that must be determined by telephone interview. These are draft criteria and 
will be reviewed for completeness during the Administrative year of the grant.  
 
4.3 Exclusion Criteria 
Participants who have any of the exclusion criteria during screening or the baseline 
visit will be excluded study participation. These exclusion criteria include: 
 Specific conditions other than degenerative disease or spinal stenosis as cause 
of LBP (e.g., metastatic cancer, vertebral fracture, spinal infection, ankylosing 
spondylitis, spondylolisthesis).  
 Prior lumbar spine surgery 
 sciatica, or scheduled visits to a neurosurgeon or orthopedic surgeon.  
 Receiving or seeking compensation for back pain 
 Red flags of serious underlying illness (e.g., recent unexplained weight loss of 10 
lbs or more, fever, recent increase in pain intensity) 
 Have received Tai Chi training in the last 12 months or practiced yoga more than 
5 times in that period. Other disabling conditions that might confound treatment 
effects (e.g., disabling heart or lung disease or diabetic neuropathy) 
 Conditions making consent or treatment difficult (e.g., unwilling or unable to 
attend classes and practice at home, major psychoses, dementia, severe vision 
or hearing problems, lack of transportation, unable to read or speak English; 
cannot transfer weight from one leg to another or bend at the hips) 
 Conditions making treatment unsafe or inappropriate (e.g., inability to stand 
independently, absolute contraindications to exercise such as uncontrolled 
arrhythmia, unstable angina, acute MI or CHF) 
 Unwillingness to give informed consent 
 
4.4 Study Enrollment Procedures 
 
Our standard recruitment approach will be to use Kaiser Permanente 
Washington’s electronic administrative and clinical databases to identify potentially 
eligible GH members who are at least 65 years of age with a visit to a health care 
provider that resulted in a diagnosis consistent with low back pain.    We then mail 
invitation letters describing key eligibility requirements and describing logistical aspects 
of the trial to GH members at least 3 months after they have visited a GH provider for 
back pain.  Individuals with interest in the study will be asked to either return a 
statement of interest or call our toll-free project number with their contact information. A 

Page 13 of 47 
Research Specialist will then phone interested enrollees to answer questions, obtain 
oral consent for an initial telephone eligibility screen and determine preliminary eligibility 
using a computer program to guide the interviewer through a series of screening 
questions. The screening process will end with documentation in a database of either 
preliminary eligibility or ineligibility. Individuals whose responses suggest they are 
provisionally eligible and who interested in the feasibility RCT will then be scheduled to 
come to a group in-person assessment in a conference room at a large Kaiser 
Permanente Washington clinic. They will receive information about the details of the 
conference room location ahead of time. Individuals who were deemed provisionally 
eligible more than 10 days in advance of the scheduled baseline visit will be re-
contacted by phone to make sure that their pain levels were sufficiently high that they 
remain eligible.  
 
 
If necessary, we will explore two additional approaches:  advertising in 
newsletters targeted at KP seniors (i.e., members of the KP Senior Caucus and 
mailings sent to Medicare recipients receiving care at KP) and through mailings to older 
adults meeting our eligibility criteria (based on data in the EMR) who have not recently 
visited their physician for back pain.  It is likely that a substantial number of these older 
adults will have impairing cLBP but have given up on seeking medical care because it 
has not been effective or has had significant side effects. 
 
 
In addition to inviting Kaiser Permanente Washington enrollees, we will also 
recruit participants from the general population of seniors in the Seattle-area. For 
general population recruitment, we will use a variety of recruitment methods such as 
radio ads, flyers on community bulletin boards, blogs, and direct mail postcards. If we 
are having trouble reaching seniors with chronic low back pain, we will enlist the help of 
our patient partners to help identify recruitment sources most relevant for the senior 
population. For the direct mail postcards, we will use a list service to purchase lists 
which include the name and addresses of people living within our recruitment area who 
are within the study age-range. People on the list will be sent a direct mail postcard 
which gives study information and directions for how to contact study staff if interested 
in participating. Once an interested person has contacted the study, the process will be 
the same as detailed above and the phone call will be analogous to returning the study 
postcard.  
 
 
Those persons deemed preliminarily eligible will be scheduled to attend one of 
our in-person group eligibility screening and assessment visits at a Kaiser Permanente 
Washington Medical Center. While the in-person visits are in a group setting, physical 
assessments and randomization will take place in a private room adjacent to the group 
area. This method has worked well in other studies conducted by Drs. Sherman and 
Rosenberg, but will be modified if suggested by the patient partners. During the group 
assessment visit, eligibility will be confirmed through completion of a final eligibility 
screening (e.g. demonstration of sufficient mobility, willing ness to be randomized). If 
the participant is deemed eligible and is willing to participate, informed consent will be 
administered by a study Research Specialist. This will include an explanation of 
interview time commitments and content, intervention commitments (class attendance, 
home practice, and home practice diary completion), potential risks of participation, 

Page 14 of 47 
potential benefits of participation, what to do for an adverse event, and options for 
discontinuation of participation in the study.  The Research Specialist will also explain 
the handling of data and personal health information as dictated by HIPAA. After 
informed consent is obtained, the baseline questionnaire will be administered using 
either a study tablet computer or a paper questionnaire, whichever the participant 
prefers. The Research Specialist will be present and available to answer any questions 
that might arise while the participant is completing the baseline questionnaire. To 
ensure that all key outcome measures are collected at the baseline appointment, we will 
also have participants’ complete physical assessments (Short Physical Performance 
Battery, Four Square Step Test, Gait Speed).  Once the baseline questionnaire and 
physical assessments are complete, the Research Specialist will answer any remaining 
questions and randomize the participant to one of our study groups. Signed consent 
forms will be kept at the KPWHRI in a locked filing cabinet only accessible by the 
appropriate study staff.  
 
 
Study staff will randomize each individual to their treatment group using a 
computer program, accessible by a laptop, designed to ensure that treatment allocation 
cannot be changed after randomization and cannot be viewed in advance. Our 
biostatistician will provide our study programmer with a computer-generated sequence 
of random numbers that will be then inserted into the computer program. Physical 
assessments and randomization will be carried out in a private space adjacent to the 
group visit room. Participants will be randomized in blocks of varying size to ensure 
balanced but unpredictable assignment of participants to both groups. Participants 
randomized to Tai Chi will be provided information about the time and location of the 
first class. This process, modified as necessary for older adults, will be repeated to 
assemble two consecutive recruitment cohorts of 32 participants.  In the first cohort, 19 
participants will be randomized to Enhanced Tai Chi protocol and 19 to Usual Medical 
Care. In the second cohort, 20 participants will be randomized to Enhanced Tai Chi 
protocol, 15 to the Comprehensive Health Education Classes (AC Group), and 5 to 
Usual Care.  The advice from our patient partners, our team members with experience 
conducting studies of physical activity in older adults and the experience we gain 
enrolling participants in our small Tai Chi study this summer, will help ensure that our 
standard recruitment procedures are modified appropriately for this new study 
population. We will consider whether we should conduct randomization stratified by age 
(65-79; 80+) and gender because both are related to baseline measures of back 
dysfunction and pain.7   
 
 
In our large randomized trial of acupuncture for cLBP, we found no differences in 
the baseline characteristics of participants recruited through mailings and through 
advertisements in the health plan’s quarterly magazine.42 
  
5. STUDY INTERVENTIONS 
5.1 Tai Chi 
To ensure that our intervention was developed thoughtfully, we adapted the frame 
work proposed by Sherman43 for developing yoga interventions, which recommends 
specification of style of practice, dose and delivery format, components of the 

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intervention, specific class sequences, use of modifications, selection and training of 
instructors, home practice facilitation, and intervention fidelity. For this feasibility RCT, 
treatment protocols were developed for both standard Tai Chi and for a maintenance 
period wherein the protocol is tapered. The treatment components are outlined below, 
with further details given in the study protocol along with items to be developed. The 
intervention includes strategies for ensuring intervention fidelity (i.e., “the extent to 
which core components of interventions are delivered as intended by the protocols”),44 
because it is essential for accurately interpreting treatment effects.  The Treatment 
Fidelity Workgroup of the NIH Behavior Change Consortium (BCC) developed 
recommendations for incorporating strategies for monitoring and enhancing treatment 
fidelity in behavioral interventions.45 Many are relevant for Tai Chi.  Many of these 
recommendations are covered in Sherman’s framework (i.e., provider training, 
treatment delivery, treatment receipt) but we will ensure the other relevant 
recommendations are all incorporated into our trial, as described below.  
 
5.1.1 Documentation of the Enhanced Tai Chi Treatment Protocol 
The Tai Chi consultants developed a detailed Tai Chi intervention manual. It 
includes the lesson plans for each class (including a description of the key features and 
photos and suitable visual imagery).  
The latter will be supplemented with a teacher training manual, containing the most 
effective strategies for ensuring treatment fidelity, the minimum qualifications for Tai Chi 
instructors, how they will be recruited, trained on the study protocol, tested and 
monitored for adherence to the protocol, and how their skills will be maintained during 
the study period.  This manual will include all study materials given to participants (e.g., 
hard copy or DVD descriptions of the movements they are learning), and checklists for 
evaluating instructor adherence to the treatment protocol. 
 
5.1.2 Standard Tai Chi Protocol for cLBP  
   Our Standard Tai Chi intervention will include group classes – each 60 minutes – 
of Yang style Tai Chi twice week for 12 weeks. We chose to use the Yang style 
because it is the most popular form of Tai Chi worldwide, can be delivered in a simple 
format that is easily replicated, has been used in numerous RCTs46 and is known 
effective for falls prevention.47 Twelve weeks of twice-weekly classes is the most 
commonly used dose of Tai Chi in RCTs and has proved practical for older adults in 
other studies.46 Therefore, this should be sufficient instruction to understand the 
fundamentals and practice safely. Consultant Tai Chi instructor Kim. Ivy and Tai Chi 
researcher Dr. Peter Wayne, who each have over 35 years of Tai Chi training and 
teaching experience, developed the Tai Chi intervention based on their prior experience 
with this population. Guided by the literature on beneficial treatments for chronic pain, 
classes will include the following components: simple classical Tai Chi movements to 
enhance musculoskeletal strength and flexibility, efficient posture, heightened body 
awareness, mindful diaphragmatic breathing, and healing imagery and visualization.16 In 
addition, by using a class format, psychosocial interaction can be enhanced. All 
movements were designed to assure safety and emphasize those that are most 
relevant to persons with cLBP.  
 

Page 16 of 47 
    In both cohorts, the first class will begin with a short introduction to Tai Chi 
principles, an overview of the class format and curriculum, and expectations regarding 
home practice. All subsequent classes will include an initial check-in period to discuss 
any questions or concerns related to prior classes and/or home practice. Formal Tai Chi 
instruction will begin with a focus on posture and abdominal breathing followed by basic 
Tai Chi warm-up exercises to loosen up the physical body, reinforce Tai Chi principles 
of incorporating mindfulness and imagery into movement, promote overall relaxation, 
and generating awareness of efficient breathing. The centerpiece of the protocol will 
include six Tai Chi movement flows over the course of the 12 weeks: ‘opening move: 
step out, raise and lower arms’; ‘grasping sparrow’s tail on the left side; ‘grasping 
sparrow’s tail on the right side’; ‘single whip’, ‘cloud hands’; ‘repeat of single whip’, ‘step 
back, lower arms’.48 Classes will end with a closing and centering breathing exercise. 
These movements will be progressively added to the warm-up and cool down exercises 
over the 12 week intervention (i.e., movement 1 introduced during week 1; movements 
2 and 3 during weeks 2-5; and the remaining movements during weeks 6-10). The class 
format for each week is shown below.  
 
Table 1. Standard Tai Chi Class Format: Proposed Version 
Week
PROPOSED Class Format
1 
1. Introduction & Overview of Tai Chi program (5 min) (1st class) and 
Greetings & Discussion of Home Practice Efforts (5 min) (2nd class) 
2. Explanation of Basics: Posture, Breathing, Mental State (5 min) 
3. Introduction of Relaxation Sequence, Breathing & Standing 
Meditation (10 min) 
4. Warm-up Exercises: #1 (10 min)  
5. Learn Movement  #1: Opening Move: Step Out, Raise and Lower 
Arms (10 Min) 
6. Student Practice & Individual Correction/Modification (10 min)  
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q & A (5 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#1 & Movement #1  (2 min)  
2 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Review of Basics: Posture, Breathing & Mental State (5 min) 
3. Relaxation Sequence, Breathing & Standing Meditation (5 min)  
4. Warm-up Exercises #1 & 2 (10 min)  
5. Repeat/Practice/ Correct/Modify Movement Flow #1 (5 min) 
6. Learn Movement Flow #2, Element #1: Ward Off Left (10 min)  
7. Student Practice Movement Flows #1&2 (Element #1), Individual 
Corrections/Modifications (10 min)  
8. Closing, Centering Breath & Visualization of Movement (3 min) 
9. Q & A (2 min) 
10. Review Homework assignment: Relax & Check Posture; Warm-
up #1 & 2 & Movement #1 & 2, element #1 (5 min)  

Page 17 of 47 
3 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #1,2,3 (10 minutes)  
4. Repeat/Practice/ Correct/Modify previous Movement flows (10 
min) 
5. Learn Movement Flow #2, Element #2, Grasping Sparrow’s Tail: 
Roll Back, Press & Push (10 min) 
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#1 & 2 & Movement #1 & 2 (entire) (5 min)  
4 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 (10 min)  
4. Repeat/Practice/ Correct/Modify Previous Movement Flows (10 
min) 
5. Learn Movement Flow #3, Transition & Grasping Sparrow’s Tail, 
right side; (10 min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4; Movement #1,2 & 3 (5 min)  
5 
(Repeat Week #4)  
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 (10 minutes)  
4. Repeat/Practice/ Correct/Modify Previous Movement Flows (10 
min) 
5. Review Movement Flow #3, Transition & Grasping Sparrow’s Tail, 
right side; (10 min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4; Movement #1,2 & 3 (5 min)  
6 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 & 5 (10 minutes)  
4. Repeat/Practice/Correct/Modify Previous Movement Flows (10 
min) 
5. Learn Movement Flow #4, Single Whip (10 min) 

Page 18 of 47 
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4; Movement #1,2,3 & 4 (5 min)  
7 
(Repeat Week #6) 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 & 5 (10 min)  
4. Repeat/Practice/Correct/Modify Previous Movement Flows (10 
min) 
5. Review Movement Flow #4, Single Whip (10 min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4,5; Movement #1,2,3 & 4 (5 min)  
8 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 & 5 (10 minutes)  
4. Repeat/Practice/Correct/Modify Previous Movement Flows (10 
min) 
5. Learn Movement Flow #5, Cloud Hands & Repeat Single Whip (10 
min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4, 5; Movement #1,2,3,4, 5& 4 (5 min)  
9 
(Repeat Week #8)  
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises #2,3,4 & 5 (10 minutes)  
4. Repeat/Practice/Correct/Modify Previous Movement Flows (10 
min) 
5. Learn Movement Flow #5, Cloud Hands & Repeat Single Whip (10 
min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4, 5; Movement #1,2,3,4, 5, & 4 (5 min)  

Page 19 of 47 
10 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises, Choose from: #1-6 (10 min)  
4. Repeat/Practice/Correct/Modify Previous Movement Flows (10 
min) 
5. Learn Movement Flow #6, Cross Hands, Close (10 min)  
6. Student Practice & Individual Correction/Modification (10 min) 
7. Closing, Centering Breath & Visualization of Movement (3 min) 
8. Q& A (2 min) 
9. Review Homework assignment: Relax & Check Posture; Warm-up 
#2,3,4, 5; Movement #1,2,3,4,5, 4 &6 (5 min)
11 
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises, Choose from: #1-6 (10 min)  
4. Review entire sequence (15 min)  
5. Student Practice & Individual Correction/Modification (15 min) 
6. Closing, Centering Breath & Visualization of Movement (3 min) 
7. Q& A (2 min) 
8. Review Homework assignment: Relax & Check Posture; Warm-
ups 1-6, Entire Flow Sequence (5 min) 
12 
(Repeat Week #11)  
1. Greetings & Discussion of Home Practice Efforts (5 min) 
2. Relaxation Sequence, Breathing & Standing Meditation (5 min) 
3. Warm-up Exercises, Choose from: #1-6 (10 min)  
4. Review entire sequence (15 min)  
5. Student Practice & Individual Correction/Modification (15 min) 
6. Closing, Centering Breath & Visualization of Movement (3 min) 
7. Q& A (2 min) 
8. Review Homework assignment: Relax & Check Posture; Warm-
ups 1-6, Entire Flow Sequence (5 min) 
 
In each class, modifications will be employed as necessary for participants who have 
physical limitations. The most common modifications are reducing slightly the depth of 
the postural stance due to knee pain and lowering the height of the arms due to 
shoulder issues. However, we will take note of all physical issues and see whether the 
protocol should be modified or additional modifications should be recorded as part of 
the protocol finalization for the full-scale trial. 
 
The Tai Chi classes will be offered in large, quiet classrooms at Kaiser Permanente 
Washington facilities that are centrally located and that provide easy access for persons 
with physical limitations. We have successfully used such classrooms in previous 
studies. 
 

Page 20 of 47 
Study participants who are randomized to the Tai Chi intervention will be asked to 
practice at home on all non-class days for 15 minutes. The home practice assignments 
are shown in Table 2. We will prepare home practice aides to assist with this (e.g., 
videos with the sequences available on Youtube or a DVD).  
 
Table 2. Home Practice Assignments 
Week(s)
Home Practice Assignment
1 
Relax & Check Posture; Warm-up #1 & Movement #1   
2 
Relax & Check Posture; Warm-up #1 & 2 & Movement #1 & 2, 
element #1  
3 
Relax & Check Posture; Warm-up #1 & 2 & Movement #1 & 2 
(entire)  
4, 5 
Relax & Check Posture; Warm-up #2,3,4; Movement #1,2 & 3  
6 & 7 
Relax & Check Posture; Warm-up #2,3,4, 5; Movement #1,2,3 & 4  
8 & 9 
Relax & Check Posture; Warm-up #2,3,4,5; Movement #1,2,3,4, 5 & 
4 
10 
Relax & Check Posture; Warm-up #2,3,4, 5, 6; Movement #1,2,3,4,5, 
4 & 6  
11&12 
Relax & Check Posture; Warm-ups 1-6, Entire Flow Sequence  
 
5.1.3 Maintenance Tai Chi Protocol for cLBP  
A key feature of receiving benefits from mind-body interventions like Tai Chi is the 
probable need to continue regular practice in order to continue receiving their benefits. 
Consequently, investigation of strategies for maintenance of long term practice is 
important. We will therefore investigate a suite of strategies for achieving this goal. We 
have adopted ideas from the health promotion literature as well as from the chronic pain 
literature. We plan to investigate the value of adding additional classes at the end of the 
primary intervention period. By tapering class frequency over the course of an additional 
24 weeks, we can investigate whether such a strategy is practical, leading to better 
maintenance of a Tai Chi practice over the longer term and therefore improving back 
function, pain, balance, mood and overall quality of life. During this maintenance period, 
we propose 6 weeks of weekly classes, 6 weeks of classes every other week (i.e., 3 
classes) and 12 weeks of monthly classes (i.e., 3 classes) to offer a high enough dose 
to encourage long term maintenance.49 Classes will be 60 minutes as in the Standard 
Tai Chi protocol and will include the movement flows and as well as the other 
components that were part of the Standard Tai Chi classes. Participants will be asked to 
practice at home for 15-minutes on all non-class days.  
 

Page 21 of 47 
The Tai Chi classes will be offered in large, quiet classrooms at Kaiser Permanente 
Washington facilities that are centrally located and that provide easy access for persons 
with physical limitations. We have successfully used such classrooms in previous 
studies. 
 
5.1.4 Selection and training of instructors 
Tai Chi consultant Kim Ivy will teach the classes for our two Tai Chi cohorts. She is 
exceptionally experienced with over 35 years of practicing Tai Chi and has run a 
successful Tai Chi school in Seattle for over 20 years. In a future trial, we will require all 
instructors to have a minimum of 10 years of practice of Yang style Tai Chi, have taught 
for at least seven years with five years of experience teaching seniors, have current 
CPR certification and be willing to adhere to our study protocol. In addition, we will 
require an in-person demonstration to ensure that they have relevant mastery of Yang 
style Tai Chi, general teaching competence, comfort giving verbal instruction, flexibility 
in teaching style and excellent interpersonal dynamics. The demonstration will include 
evaluation of their own Yang style form as well as their ability to instruct others in warm-
ups and selected tai chi flows that are relevant to this protocol. In addition, they will 
attend our in-person teacher training, which will include an introduction to the study 
design and participant inclusion and exclusion criteria, an in depth discussion of the 
protocol, with practice teaching for consistency among instructors and special issues 
that may arise in this population. Because Ms. Ivy is very well connected with the 
Seattle tai chi community, she will be able to easily recruit instructors who are likely to 
be successful as instructors in this study. If additional instructors are necessary for this 
feasibility study, Ms. Ivy will train them. 
 
5.1.5 Home practice facilitation  
We will supplement classes with 15-minutes of home practice on several non-study 
days and practice incorporating Tai Chi principles into life. We will use Youtube videos 
and if requested, DVDs to guide the participant through the movement flows.  Home 
practice logs will be used to track home practice, a strategy we have used with some 
success in prior studies. Results from our pilot study of using an iPad app designed to 
enhance adherence to exercise found that it was not easy for study participants to use.   
 
5.1.6 Intervention fidelity:  
i. Class protocol 
For this feasibility study, Research Specialists who staff the classes will complete 
intervention fidelity checklists at all classes. Dr. Sherman, who has developed familiarity 
with the Tai Chi protocol during the development of the intervention manual, will attend 
two randomly selected classes in each of the class series to ensure the instructor is 
adhering to the protocol. She will note all observed protocol violations, both errors of 
omission and commission on the checklists developed for this purpose.  Dr. Sherman 
will also be in weekly contact with Kim Ivy during each class series to ensure any 
questions or concerns are quickly identified and resolved (Consultant Wayne will be 
brought in if necessary). We will focus on the suitability of these procedures for a larger 
study and to making any necessary modifications.  
ii. Optimizing treatment dose 

Page 22 of 47 
 
Tai Chi requires some focused attention to learn the fundamentals undergirding this 
mind-body therapy and requires continued practice in order to maintain benefits..  
Participants will receive a reminder call before the first class and whenever they miss 
any classes.. During each class, participants will be reminded of the importance of 
attending classes and of practicing at home. A portion of each class will be devoted to 
answering questions that arise during home practice and, if necessary, to exploring any 
perceived barriers to adherence. Research Specialists will take attendance at each 
class. 
 
iii Develop strategies to assess participants’ understanding of intervention and 
ability to engage in Tai Chi 
We will evaluate several methods to assess the extent to which participants feel 
comfortable and understand the techniques they are being taught and their confidence 
in performing them in class and practicing them at home.  This will include having a 
Research Specialist observe each class and note any observed difficulties (as well as 
corrections given by Instructor Ivy), asking about these issues on our follow-up 
questionnaires, and possibly having another Tai Chi instructor observe and rate each 
participant’s movements during classes (e.g., unable to perform movements, 
low/moderate/high skill in performing the movements).   
 
iv. Documentation of intervention fidelity 
In addition to identifying any general problems with our implementation procedures 
or with specific aspects of the treatment protocols, we will determine the level of 
adherence to class attendance and home practice in the standard and maintenance 
time periods.  Class attendance will be documented by a Research Specialist who will 
attend all of the classes to manage study-related processes and allow the Tai Chi 
instructor to pay full attention to her students.  We will also collect data from students on 
home practice.  At the first class, we will give participants weekly logs to record their 
home practice throughout the 36-week intervention period (We will ask that they bring 
their logs to class once a week and to give them to the Research Specialist).  We have 
used this process in our recent yoga RCT55 with moderate success.  In addition, we will 
ask participants during the 12, 26 and 52-week follow-up interviews about the number of 
days they practiced during the prior week and the average number of minutes they 
practiced on those days.  This method of collecting data on home practice has worked 
well in our previous RCTs.  Finally, we will assess treatment fidelity by reviewing the 
information we collected evaluating the ability of the Tai Chi instructor to adhere to the 
treatment protocols and the extent to which participants were able to grasp what they 
were taught and translate it into skillful Tai Chi movements. 
 
5.1.7 Allowed Interventions 
 
For ethical and legal reasons, all participants will be permitted whatever care 
they would receive as part of their medical coverage provided by Medicare and any 
other supplemental insurance they have.  
 
5.2 Usual Medical Care 
This group will receive whatever care they would normally receive during the study 
period.  Usual medical care for chronic back pain typically includes continued use of 

Page 23 of 47 
medications (mostly non-steroidal anti-inflammatory medications) and visits to primary 
care physicians, physical therapists, and complementary medicine providers. In order to 
adequately describe the care that has been provided, we will collect information from 
the GH electronic medical record describing any imaging and other tests ordered, 
medications (prescribed or recommended use of over the counter), written advice given, 
notes on activity level, exercise, referrals to physical therapy, complementary therapies, 
medical specialists, any surgeries performed) as recommended by Somerville et al.57   
 
We think this is the best control group for this study because it is the only one that 
can answer the practical question of whether Tai Chi, when added to usual medical 
care, is beneficial for relieving cLBP and associated dysfunction. Guidelines for optimal 
care of older adults with cLBP do not exist and we therefore cannot use guideline-driven 
case. No clear package of standard care exists and thus, careful documentation of 
usual medical care, including the need for specialist care and for surgeries will be 
clearly documented.  
 
A substantial fraction of persons with chronic back pain rely on self-care, only 
occasionally seeking professional help.  In order to minimize disappointment at not 
being randomized to Tai Chi, participants in the Usual Medical Care group will receive a 
gift from the study, which will be a stainless steel water bottle with the Kaiser 
Permanente logo.  Compensation has helped maintain high response rates (i.e., close 
to 90%) from control group participants in our previous trials, but we suspect that a gift 
will be more appreciated than cash in this population. However, we will follow the 
guidance from our patient partners. 
 
5.3 Attention Control 
 
Our attention control is designed to match on attention and time in the standard 
tai chi intervention (i.e., 2x/week of 12 week 60 minutes) and credibility (health 
education topics of value to seniors that they think could impact their back pain). Each 
of the 60 minute sessions will include interesting didactic material along with questions 
and a brief discussion. The sessions will be presented by students in the University of 
Washington nurse practitioner training program, pharmacy interns and the Study 
Investigators, geriatric fellows and other expert colleagues when available. We will have 
a Research Assistant attend the classes to provide continuity and they will be selected 
for their interest and ability to work with this age group. The didactic material has been 
selected from a variety of medical (e.g., UptoDate; various Kaiser Permanente 
Washington guidelines), scientific (e.g., PubMed, National Institutes of Health, CDC), 
and community sources (e.g., National Caregiver Association). 
Table 3: Health Education Classes 
Week
1st 
Class  
Topic 
2nd 
Class 
Topic 
1 
1 
Healthy Living 
2 
Back Pain 
2 
3 
Nutrition 
4 
More Nutrition 
3 
5 
Using Meds Safely 
6 
Flu/Pneumonia 
Prevention 
4 
7 
Osteoporosis 
8 
Fall Prevention 

Page 24 of 47 
5 
9 
Brain Health 
10 
Heart Health and Stroke 
6 
11 
Safe Driving 
12 
Diabetes 
7 
13 
Communicating with 
your physician 
14 
Skin Health 
8 
15 
Caregiving 
16 
Osteoarthritis 
9 
17 
Housing  Options 
18 
Depression 
10 
19 
Bladder Problems 
20 
Sleep 
11 
21 
Social Support 
22 
Stress Reduction 
12 
23 
Footwear 
24 
Wrap Up 
To minimize the likelihood that the seniors will achieve improvement in pain and 
functional status, we placed those topics we thought most relevant to chronic pain for  
many older adults(e.g., depression, osteoarthritis,  sleep, stress reduction)  toward the 
end of the intervention. We will also inquire about any changes they made in their life as 
a result of the classes.  
 
6. DESCRIPTION OF STUDY VISITS AND OUTCOME MEASURES  
 
Table 4 presents the schedule of evaluations, while Table 3 further displays the 
physical and questionnaire assessments.  
 
TABLE 4. Schedule of Evaluations 
ASSESSMENT
 
Screening/
Baseline
Tai Chi 
Classes/ 
Attention 
Control 
12/26-
Wk 
52-
Wk 
Informed Consent 
x/ 
  
  
  
Demographics [baseline] 
/x 
  
  
  
Medical History [some screening, some baseline] 
x/x 
  
  
  
Inclusion/exclusion criteria [screening] 
x/ 
 
x 
x 
Physical Assessments 
x 
 
x 
x 
Questionnaire with Outcome Measures [see Table 3] 
x 
 
x 
x  
Enrollment/Randomization 
/x 
 
 
 
Class Attendance 
 
x 
 
 
Home Practice Logs 
 
x 
 
 
Adherence to Tai Chi Protocol/Attention Control 
Protocol 
 
x 
 
 
Adverse events 
 
x 
x 
x 
Qualitative discussion [subset of participants] 
 
x 
x 
x 
 
6.1 Screening Evaluation 
 
The screening evaluation will be performed by telephone with KPW members 
who have returned a statement of interest or called our toll-free project number with 
their contact information or with members of the public who have responded to various 
forms of outreach. A Research Specialist will phone those members to answer 

Page 25 of 47 
questions, obtain oral consent for an initial telephone eligibility screen and determine 
preliminary eligibility using a computer program to guide the interviewer through a series 
of screening questions based on the final inclusion and exclusion criteria. The screening 
process will ends with documentation in a database of either preliminary eligibility or 
ineligibility. Individuals whose responses suggest they are provisionally eligible and who 
interested in the feasibility RCT will then be scheduled to come to a group in-person 
assessment in a conference room at a large Kaiser Permanente Washington clinic. 
They will receive information about the details of the conference room location ahead of 
time. Individuals who were deemed provisionally eligible more than 10 days in advance 
of the scheduled baseline visit will be recontacted by phone to make sure that their pain 
levels were sufficiently high that they remain eligible.   
 
6.2 Enrollment, Baseline and Randomization 
 
Study participants will be enrolled in the study when they have completed their 
written informed consent, their baseline physical assessments, baseline questionnaire, 
and been randomized (see Section 4.4 for further details). Documentation of 
randomization will take place by computer. All participants will be enrolled within two 
weeks of the first class of each cohort. We will use the recommendations made by the 
NIH Task Force on Research Standards for Chronic Low Back Pain for studies of 
chronic low back pain.  and for specific baseline information, including a core set of 
baseline outcome domains, and appropriate PROMIS measures for these domains58 
Baseline information will include sociodemographic characteristics (gender, age, race, 
ethnicity, education level, employment status, and marital status), back pain history 
(e.g., years since first episode of back pain, duration of current episode) and other 
factors that are prognostic of resolution of back pain (e.g., number of pain sites and 
patient expectations of treatment outcome).  The core set of recommended outcomes 
includes physical function, low back pain intensity, pain interference, depression, sleep 
disturbance, and catastrophizing. The Baseline Schedule of assessments in shown in 
Table 3 and the specific outcome assessments are described further in Section 6.2.4.  
 
6.3 Blinding 
 
Research Specialists who collect data on physical measures will be masked to 
treatment group at all time points. Participants, the instructor and the many study staff 
will necessarily be aware of group assignment. 
 
6.4 Follow-up Visits  
 
To maximize response rates, reminder letters will be sent before each follow-up 
visit.  The contents of the in-person follow-up visits (12, 26 and 52 week) is shown in 
Table 2. While participants are provided an opportunity to complete their assessments 
in a group format (with instructions not to discuss their group assignment), physical 
assessments (Short Physical Performance Battery, Four Square Step Test, Gait Speed) 
will take place in a private room adjacent to the group area. The follow-up questionnaire 
will be administered using either a study tablet computer or a paper questionnaire, 
whichever the participant prefers. Questions about experiences with specific aspects of 
the Tai Chi intervention that might cause participants to think differently about their 
outcomes will be asked at the end of an interview, after all other outcomes are 

Page 26 of 47 
assessed.  We will attempt to obtain outcome data from all participants in the trial. The 
Research Specialist, masked to study group, will be present and available to answer 
any questions that might arise while the participant is completing the follow-up 
questionnaire. Our patient partners will be asked about the value of the group format at 
follow-up and the likelihood we can maintain our masking with multiple participants in a 
room. If this is believed unfeasible, we will schedule visits in the same location (GH 
clinic classroom) for one individual at a time.  
 
 
 
The NIH Task Force on Research Standards for Chronic Low Back Pain made 
recommendations for a core set of baseline outcomes.58 These measures include many 
of the key outcome domains recommended for us used in trials of chronic low back 
pain.59-61 We will therefore include all of these in our questionnaire along with a few 
others. Table 3 summarizes the measures, with the NIH Task Force recommendations 
being shaded in blue. Relevant additional secondary measures of interest for virtually all 
older adults include scales assessing fear of falling and measures of balance.62,63 
 
We will modify our outcome measures in consultation with our patient partners in the 
Administrative Year prior to the RCT. Because older adults have a variety of symptoms, 
we might, for example, include the MYMOP measure,64 which allows patients to assess 
progress on their own desired outcomes from health care. Careful attention will be paid 
to ensure that the questionnaire is not too burdensome for older adults. We would aim 
for approximately 20 minutes for the follow-up questionnaires. 
TABLE 5:Content of Baseline and Follow-up Assessments  
SOURCES OF DATA FOR BACK TAI CHI TRIAL  
MEASURES
Baseline
12-Wk 
26-Wk 
52-Wk 
BASELINE INFORMATION 
  
  
  
  
Patient  characteristics (age, gender, ethnicity, race, 
employment status, education, height, weight, 
smoking status, excessive use of drugs or alcohol) 
(NIH Task Force Research Standards); education 
x 
  
  
  
Back pain history (pain duration, leg pain, other pain 
sites, low back operation, use of selected 
treatments, work loss due to back pain, disability 
status, catastrophizing, fear avoidance) 
x 
  
  
  
Expectations and knowledge of Tai Chi/Health 
Education  
x 
  
  
  
CORE SET OF OUTCOMES FOR BACK PAIN STUDIES 
* Back dysfunction (24-item Roland Morris Disability 
Questionnaire-RMDQ) 
x 
x 
x 
x 
* Low back pain intensity (0-10 numerical rating 
scale) 
x 
x 
x 
x 
Pain interference (4-items PROMIS) 
x 
x 
x 
 x 
Pain Interference and enjoyment of life (2-items 
PEG) 
x 
x 
x 
x 
Physical Function (4-items PROMIS) 
x 
x 
x 
x 

Page 27 of 47 
Depression (4-items PROMIS) 
x 
x 
x 
x 
Anxiety Screener (GAD-2) 
x 
x 
x 
x 
Sleep disturbance (4-items PROMIS) 
x 
x 
x 
x 
Patient Global Impression of Change (7 item scale) 
 
x 
x 
x 
Participant Disposition (see Section 6.4.iv) 
 
x 
x 
x 
TREATMENT-RELATED INFORMATION 
Adverse events 
  
x 
x 
x 
Perceptions of Tai Chi & HE classes, including 
instructors 
  
x 
x 
  
Adherence to assigned treatment, including home 
practice 
  
x 
x 
x 
Willingness to participate in a RCT of Tai Chi with an 
Attention Control (Cohort 1) 
x 
 
 
 
POTENTIAL CONFOUNDERS 
Use of co-interventions (medications, other 
treatments, etc.) 
x 
x 
x 
x 
Daily exercise and job-related activity 
x 
x 
x 
x 
MEASURES FOR FALLS AND BALANCE 
Short Physical Performance Battery (balance, gait 
speed, chair stand)† 
x 
x 
x 
x 
Four Step Square Test† 
x 
x 
x 
x 
Fear of Falling 
x 
x 
x 
x 
*Co-Primary Outcome Measures 
† Physical Assessment 
 
i. Co-Primary Outcome Measures  
      Back-related dysfunction will be measured with the Roland Disability Questionnaire 
(“Roland scale”)65 which asks whether 24 specific activities were limited due to back 
pain during the past week (yes or no).  This measure has been found to be reliable, 
valid and sensitive to clinical changes, and is appropriate for telephone administration 
and patients with moderate disability. This legacy questionnaire will be included as our 
primary outcome because we have used in all of our previous trials. We will also include 
the PROMIS physical function to see how they perform relative to each other.  
 
Pain  will be measured by asking participants how they would rate their back pain on 
average using a 1 to 10 numerical rating scale.58 This is likely to be very comparable to 
our previously used 0 to 10 scales to measure either the pain intensity or 
bothersomeness of back pain during the previous week on a 0 to 10 scale (0 = "not at 
all bothersome" and 10 = "extremely bothersome"). The validity of numerical rating 
scales of pain has been well documented, and such scales have demonstrated 
sensitivity to detecting change in pain after treatment.   
  
 
ii. Other Core Recommended Outcomes: 
Physical function will be assessed using the 4-item PROMIS measure.58 
 

Page 28 of 47 
Depression will be assessed with the 4-item PROMIS measure, for which there is a 
published “crosswalk” to the Patient Health Questionnaire-8 (PHQ-9) which measures 
both depression severity and current DSM-IV depression diagnostic status and which 
we have used in prior studies.66   
 
Anxiety will be measured by means of the 2-item Generalized Anxiety Disorder scale 
(GAD-2), which has demonstrated high sensitivity and specificity in detecting 
generalized anxiety disorder in primary care populations [61, 62]. 
 
Pain Interference with normal daily activities will be measured with 4 PROMIS 
measure.58 
 
Sleep disturbance will be measured with the 4-item PROMIS measure.58 
 
Patient Global Impression of Improvement [of cLBP related dysfunction] will be 
asked on a seven point scale ranging from “very much improved” to “very much worse”. 
This standard rating has worked well in our prior studies. 
 
 
iii. Selected Other Outcomes 
Use of back-related medications and exercise in past week will be measured on the 
12, 26 and 52-week questionnaires to provide an indication of how these behaviors 
were affected by the interventions.  They also provide an indication of “co-interventions” 
that occurred during the follow-up period.  
 
Qualitative outcomes:   Inclusion of open-ended questions in our previous trials has 
yielded valuable insights into participants’ feelings about the value of specific 
components of the interventions and the impact of the interventions on their lives. We 
will, therefore, include open-ended questions asking about these issues at the end of 
the 12, 26 and 52-week follow-up interviews. 
 
Fall outcomes: The Short Physical Performance Battery is a group of physical 
performance tests that combines the results of gait speed, chair stand and balance test 
into one measures that predicts disability in diverse populations.62,63 The Four Square 
test is another reliable and valid measure of balance.67 Fear of falling will be measured 
with the well validated, 7-item short form version of the Falls Efficacy Scale – 
International.68 
 
iv. Maximizing Follow-up Rates and Documentation of Follow-up 
We will attempt to obtain outcome data from all RCT participants, including those 
who have moved out of state. We will collect information on the outcomes at every 
stage of our recruitment, randomization, and treatment process so that we can report 
patient flow according to the CONSORT guidelines,69 which is necessary for assessing 
the feasibility of the study.  We will attempt to ensure high response rates by paying 
participants $25 for each completed interview.  We will calculate follow-up rates for our 
12, 26 and 52-week interviews separately for the Tai Chi, Attention Control and Usual 

Page 29 of 47 
Medical Care groups.  In our other trials we have consistently achieved short-term 
follow-up rates over 90% and one-year follow-up rates of close to 90% in our previous 
RCTs evaluating CIM treatments for cLBP70-73 by keeping interviews reasonably short, 
and compensating participants for completing the interviews. 
 
v. Assessment of Feasibility:  
 
We will collect data on the key components of the feasibility trial from four 
sources: 1) feedback from members of the research team, 2) information from the Tai 
Chi instructor and consultant Wayne, 3) data collected during the feasibility trial (e.g., 
recruitment rates, class attendance, home practice, follow-up rates, adverse events), 
and 4) data from debriefing group discussions with 30 RCT participants (16 from Tai 
Chi, 6 from Attention Control and 8 from Usual Medical Care). At the 52-week follow-up, 
30 participants (16 from Tai Chi, 6 from Attention Control and 8 from Usual Medical 
Care) will be invited to attend an intervention-specific group discussion (just after their 
final outcome assessment) to provide feedback on their experiences with all aspects of 
the study (e.g., recruitment process, Tai Chi or Attention Control protocols, outcome 
measures, adverse effects, home practice support procedures and materials).  
 
7.  ASSESSMENT OF SAFETY  
 
In a systematic review of adverse events in RCTs of Tai Chi, Wayne and 
colleagues19 reported no serious adverse events. Other adverse events were primarily 
minor musculoskeletal pain (back and knee) and occasionally falls were reported.  
 
7.1 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
 
We will collect data on adverse events from several sources and incorporate 
them into a database.  These sources are:  1) reports from the Tai Chi instructor(s) of 
any extraordinary occurrences of concern to them, 2) the questionnaires completed by 
participants at 12, 26 and 52-weeks will inquire about: any harm they felt from the Tai 
Chi classes or home practice, and any serious health problems, and 3) participants 
themselves because the consent form directs participants with injuries they believe may 
be related to the mind-body programs to call the Principal Investigator, Co-Investigators 
or the Human Subjects Representative, whose names and phone numbers are listed on 
the copy of the consent form retained by the participant.  
 
7.2 Adverse Events and Serious Adverse Events 
We will define an Adverse Event (AE) 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 to be recording regardless 
of their relationship to the study intervention.   
 
For this study, Serious Adverse Events (SAE) are defined as any research-related 
event (occurring at any dose or level of intervention) that results in any of the following 
outcomes: 
 Death;  

Page 30 of 47 
 Life-threatening event;  
 Inpatient hospitalization or prolongation of existing hospitalization;  
 A persistent or significant disability/incapacity; OR 
 Any event that when based upon appropriate medical judgment may jeopardize the 
health or well-being of the subject and may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition.  
 
 
7.3 Reporting Procedures 
 
Adverse event data from the questionnaires will be provided to the Project 
Manager within a week (and will be transferred to the AE database). These will be 
reviewed, as will AE reports from all sources, by Dr. Sherman, with the assistance of 
Co-Investigator Rosenberg (a psychologist) and James Ralston (a GHRI physician; Co-
Investigator Phalen will be available for geriatric specific issues)) on a weekly basis. Any 
SAEs identified will be reported promptly to the Kaiser Permanente Washington Human 
Subject Review Committee (the GH IRB) and the Independent Monitoring Committee 
(IMC). If an AE is reported by phone, the study staff member will complete an Adverse 
Events form, which will be entered into the database and will alert Project Manager 
Hawkes and PI Sherman of the new AE report. If a SAE is identified by phone, it will be 
reported as outlined below. Adverse events that are not serious will be recorded and 
included in regular DSM Body reports, but will not be reported early to the IMC.  
Appendix A details adverse event reporting as required by the Kaiser Permanente 
Washington IRB. 
 
Serious Adverse Events that are fatal will be reported to the IMC chair within 7 
days of discovery, regardless of attribution. The table below details the adverse event 
reporting schedule and actions: 
 
Table 4. Adverse Event Reporting Procedures 
Adverse Event
Action taking by study team 
Serious
   Fatal 
       Tai Chi Relateda
Record on AE and SAE forms
Report to DSM Body Chair within 3 days of discovery
       Not Tai Chi Relatedb
Record on AE form
Report to IMC within 7 days of discovery
   Not Fatal 
       Tai Chi Relateda
Report on AE and SAE forms
Report to IMC within 7 days of discovery
       Not Tai Chi Relatedb
Record on AE form
Report to IMC as part of regular reports
Not Serious
Record on AE form

Page 31 of 47 
Report to IMC and IRB as part of regular reports
a possibly, probably or definitely
b definitely not
 
7.4 Follow up for Adverse Events 
 
For non-serious adverse events, participants will be contacted to see how they 
are doing. They will be followed until any adverse events, at least possibly related to the 
study are resolved. The GH IRB will offer guidance about follow-up required for other 
conditions unrelated to the study.  
 
7.5 Safety Monitoring 
This is an unmasked Phase trial comparing Enhanced Tai Chi and Usual Medical 
Care for chronic back pain. Given the favorable safety profile from previous studies of 
Tai Chi including Dr. Wayne’s coupled with the small numbers of adverse events 
reported in the literature, we propose that this trial will be monitored for safety by an 
Independent Monitoring Committee. The IMC was established with NCCIH’s approval, 
and consists of a primary care physician, a biostatistician and a Tai Chi instructor.   
 
The IMCs job will be to evaluate the adverse-experience data we will provide 
them on a regular basis to protect the safety of the study participants.  Based on the 
observed adverse effects of the treatment under study, the IMC will make 
recommendations on a regular basis to the PI and the Office of Clinical and Regulatory 
Affairs at the National Center for Complementary and Integrative Health (NCCIH) 
regarding continuation, termination, or other modifications of the trial.  
 
8.  INTERVENTION DISCONTINUATION 
There are a variety of conceivable reasons participants may prematurely discontinue 
the class series and study staff will use the following groupings to categorize them: 
- 
Practice of Tai Chi  associated with unacceptable or serious adverse events from 
perspective of participant 
- 
Continued participation considered inadvisable by investigator, class instructor or 
participant’s physician due to concerns that continued participation poses an 
unacceptable risk to the patient. 
- 
Participants do not care for the class environment 
- 
Tai Chi perceived as ineffective by participant 
- 
Events in participant’s life unrelated to trial (e.g., illness or death in family) 
- 
The study is stopped by the GH IRB, the NCCIH or the OHRP 
A study withdrawal form will be completed for individual who discontinues the 
intervention. In all cases, participants who discontinue treatments will be encouraged to 
complete the remaining follow-up assessments using the regular follow-up schedule 
(i.e., 12, 26, and 52 weeks).  
 
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
In this feasibility study, we chose a parallel group design using three arms 
(Enhanced Tai Chi, Comprehensive Health Education Control and Usual Medical Care) 

Page 32 of 47 
that would be part of a 3 or 4-arm full-scale RCT if an assessment indicates that the 
larger study is feasible.   
By assembling information from interviews with study participants, the Tai Chi 
instructor, members of the research team, and from study records, we will be able to 
perform a thorough evaluation of our study procedures and protocols.  This evaluation 
will be guided by the criteria for assessing the adequacy of specific study components 
clearly specified in the Administrative Year. This information will allow evaluation of the 
overall feasibility of conducting a large RCT, the size of the pool of potential participants 
required (and therefore the number of study sites), the feasibility of including the 
maintenance Tai Chi intervention, and the adequacy of recruitment and follow-up 
procedures.  Finally, this trial will provide estimates of the baseline means and standard 
deviations of the primary outcome measures, albeit with small sample sizes.  If this 
evaluation concludes that conducting a full-scale RCT of Tai Chi for older adults with 
cLBP is feasible, this study will provide the information necessary for preparing a grant 
proposal for successfully conducting such a RCT.   
 
9.2 
Sample Size and Randomization 
Because this is a feasibility study, the sample size is not designed to detect 
clinically important effects of the primary effectiveness outcomes, back-related 
dysfunction and pain intensity.74 Rather, for this type of study, the sample size needs to 
be large enough to provide a high likelihood of surfacing any important problems that 
may exist in the study execution.74  Our sample size of 78 was chosen based on 
practical considerations to provide ample opportunity to identify problems with the study 
procedures, intervention protocols (including adherence), outcome measures, and 
follow-up rates. Therefore, a trial of this size is insufficiently powered to detect clinically 
important effects in our outcomes; for example the power would be only 48% assuming 
a 10% loss to follow-up, α=0.05 and an effect size of 0.5 (similar to a clinically important 
difference on the RMDQ in younger adults). However, we believe that our proposed 
sample size is sufficient to determine whether the trial is feasible.  
 
 
If we conclude that a full-scale RCT of Tai Chi for cLBP in older adults is feasible, 
we would calculate our sample size requirements using estimates of the standard 
deviations from large previous RCTs of other CIM interventions of older adults,75 
accepted criteria for the minimum clinically important difference for the RMDQ (our 
primary outcome measure, which would be measured as a continuous variable),76 
standard levels of type I (α=0.05) and type II (β between 0.1 and 0.2, for power between 
80% ad 90%) errors, and dropout rates and missing data rates estimated from this 
study’s follow-up rates. If appropriate, the contemporary “best practice” method of 
imputation for missing data (e.g., multiple imputation) would be used.  
 
 
Participants would be randomized to each of the three study arms (Enhanced Tai 
Chi, Comprehensive Health Education and Usual Medical Care). Our study 
biostatistician would prepare a computer-generated sequence of random numbers that 
will be inserted into a special computer program for randomization. The program will 
contain blocks of varying sizes to ensure balanced but unpredictable assignment of 
participants to both groups. We will consider whether we should conduct randomization 

Page 33 of 47 
stratified by age (65-79; 80+) and gender because both are related to baseline 
measures of back dysfunction and pain.7  If we decide to do this, we would incorporate 
a stratified randomization scheme into the computer program. We are experienced with 
both methods of randomizing participants. Further details related to randomization were 
provided in section 4.4. 
 
9.3  
Definition of Populations 
 
In a full-scale trial, we would perform an intention to treat analysis. Therefore we 
would include all participants who were randomized into the trial, regardless of whether 
they participated in the assigned treatments.  By using this approach, we would 
minimize biases that often occur when participants who do not receive the assigned 
treatments are excluded from analysis. In the full-scale trial, we would also perform a 
per protocol analysis that included only individuals who adhered to the Tai Chi class 
protocol, using a threshold that we will determine in our Administrative Year.  
 
9.4 
Interim Analyses and Stopping Rules 
We are not planning any interim analyses for this feasibility study.  
 
The trial will be stopped only if the Safety Monitoring Body (SMB), the KPW IRB, 
the NCCIH or the OHRP believes there is an unacceptable risk of serious adverse 
events in the Tai Chi treatment arm. In this case, the SMB could decide to terminate the 
entire trial. Based on our previous research and on the small number of reports of 
adverse events from these treatments reported in the literature, we believe the risk of 
Serious Adverse Events related to our Tai Chi intervention is quite small, having never 
been documented in the literature. We are not planning to stop the study for slow 
accrual or high losses to follow-up because in this feasibility study, we would make 
changes in recruitment and follow-up procedures to try to maximize the feasibility of the 
study. We would therefore consider difficulties in these areas as signals that changes in 
our proposed methods are necessary.  
 
9.5 
Outcomes  
Our feasibility outcomes will include the information we would to report 
participant flow in the feasibility RCT according to the CONSORT guidelines,69 This will 
include collect information on the outcomes at every stage of our recruitment, 
randomization, and treatment process and follow-up time periods. Many of these 
outcomes will be collected directed by computer, while others will first be collected with 
paper forms and then transferred to our database.  
At the baseline and 12, 26, and 52-week follow-up study visits, outcome 
measures and physical assessments will be collected as described in Table 3 (section 
6.2.4). The primary outcome measures in the full-scale trial would be back-related 
function (Roland Morris Disability Questionnaire) and back pain intensity. Further details 
on these measures are provided in Section 6.2.4. 
 
9.6 
Data Analyses  
i. Feasibility of a full-scale RCT 

Page 34 of 47 
We will use descriptive analyses to examine many aspects of feasibility, including 
recruitment, randomization, Tai Chi adherence, adverse events and follow-up rates. To 
assess recruitment feasibility, we will collect information at every stage of our 
recruitment and randomization process. We will compute the rates of screening and 
enrollment per month. This will let us know how many invitation letters we would need to 
send to potentially eligible persons to meet recruitment goals in a large RCT.  Our 
primary method of recruitment will be through mailed invitations to persons meeting our 
initial inclusion and exclusion criteria according to the information in the EMR (see 
sections 4.2 and 4.3).  This recruitment method will allow us to calculate the percentage 
of these potentially eligible persons who end up agreeing to participate in the trial.  
Because ICD codes do not distinguish between chronic and acute pain and do not 
always distinguish between pain in the lumbar spine (low back) from pain in mid-back or 
neck, most potentially-eligible persons will be found during screening interviews to not 
have cLBP. This information will help determine the number of recruitment sites that 
would be necessary to conduct an adequately-powered RCT.  If our primary recruitment 
method proves inadequate for efficiently meeting our goals, we will evaluate the ability 
of alternative methods determined in the Administrative Year (e.g., advertising in the 
health plan’s quarterly magazine) to accrue significant numbers of additional 
participants.   
 
To assess RCT retention rates, we will compute the treatment specific retention 
rates, which are typically large in our trials. For Tai Chi treatment adherence, we will 
compute the number of classes attended and the amount of home practice per week. 
Benchmarks for Tai Chi adherence will be derived (in the Administrative Year) by a 
thorough literature review of adherence in RCTS evaluating exercise for cLBP, Tai Chi 
for chronic pain and Tai Chi in the elderly. Additional information, such as ratings of how 
well participants perform key aspects of the Tai Chi protocol, will be obtained.  
 
To assess safety, we will compute the proportion of persons reporting adverse 
events as well as the type and seriousness of the event. In our prior studies, 15 to 29% 
of participants reported mild transient increases in pain when stretching or doing yoga. 
We think adverse events for Tai Chi may be similarly mild , but slightly less common 
because of the nature of the movement. 
 
To assess follow-up rates, we will compute treatment specific and overall follow-
up rates at each time point. While our prior trials have consistently had post-treatment 
follow-up rates over 90% in the short term and close to that at one-year follow-ups, we 
will consider follow-up rates of 80% or better to indicate feasibility.  
 
As described in Section 6.2.4iii, we will obtain qualitative feedback on all aspects 
of the study from 30 participants. Our prior experience suggests this number is sufficient 
to elicit a broad range of experience and to begin to see themes and experiences 
repeated across respondents (i.e., achieve “response saturation”)77,78  Dr. Rosenberg, 
an experienced qualitative researcher, will conduct these discussion groups, which will 
be audio recorded and transcribed. We will also invite suggestions for improvement in 
the study procedures and protocols. Because these debriefing interviews will inquire 

Page 35 of 47 
about specific experiences and suggestions for improving our procedures and protocols, 
our analyses will be largely descriptive and not require resource-intensive ethnographic 
analysis techniques. 
 
ii. Information required for full-scale RCT 
 
If we conclude that a full-scale RCT of Tai Chi for cLBP in older adults is feasible, 
we will calculate our sample size requirements using estimates of the standard 
deviations from large previous RCTs of other CIM interventions of older adults,75 
accepted criteria for the minimum clinically important difference for the RMDQ (our 
primary outcome measure),76 standard levels of type I and type II errors, and dropout 
rates estimated from this study’s follow-up rates. 
 
We plan to analyze the data in the full-scale RCT using the recommendations 
from the RTF.58 Because most of the outcome measures they propose are relatively 
new, it is important for us to compute summary statistics for these measures (e.g., 
means, percentages) so that we can compare our population to others reported in the 
literature and so that we can identify issues with missing data, etc. Using data from this 
feasibility RCT, we plan to conduct preliminary analyses using the recommendations 
from the RTF (i.e., examine continuous outcomes, perform responder analyses [the 
proportion of study participants who achieve specific thresholds], and look at the 
cumulative distribution function for improvement by treatment group to see what 
challenges, if any, we encounter. Finally, we will also stratify patients in this study by the 
personal impact of cLBP on them. We will use the recommended Impact Stratification 
approach to see what the distribution would be in this population and whether sub-group 
analyses are likely feasible in the full-scale RCT. 
 
iii. Preliminary Outcome Analyses 
Preliminary analyses will not be properly powered, but will alert us to potential 
analytic challenges in the full-scale trial. We will employ the analytic techniques we 
would propose in a full-scale trial.  In our comparisons of treatments on the outcome 
measures, we will analyze outcomes from all follow-up time points in a single model, 
adjusting for possible correlation within individuals and treatment group cohorts using 
generalized estimating equations (GEE).79  Because we cannot reasonably make an 
assumption of constant or linear group differences over time, we will include an 
interaction term between treatment group and time point. We plan to adjust for baseline 
outcome value, gender, and age of analyses The general form of the regression model 
will be: 
ε
α
α
α
β
β
))
(
(
3
2
1
1
0








z
Time
Trt
Trt
Baseline
t
Y
g
, where Y(t) is the 
response at follow-up time t, Baseline is the pre-randomization value of the outcome 
measure, Trt include a dummy variables for the Tai Chi group or the Comprehensive 
Health Education Control group, Time is a series of dummy variables indicating the 
follow-up times, and z is a vector of covariates representing other variables being 
adjusted for.  (Note that 1, 2, and 3 are vectors.) The referent group in this model is 
the Usual Medical Care group. For binary and continuous outcomes, we will use 
appropriate link functions (i.e., logit for binary).  
 
10. DATA COLLECTION, QUALITY CONTROL AND CONFIDENTIALITY  

Page 36 of 47 
10.1 Data Collection Forms 
 
Eligibility information will be collected directly in a computer assisted telephone 
interviewing database. Baseline and follow-up questionnaires will be self-report on 
paper forms or, if necessary, via telephone interview. Masked assessors (trained 
Research Specialists) will collect data on the physical assessments using paper forms.  
 
Individual records will be identified by a unique study identification number. 
Records linking study ID with participant names or other identifying information that may 
be needed for follow-up interviews, class attendance, etc. will be kept separate from the 
study data and will be accessed only by study team members on a need-to-know basis. 
All study files will be kept in a locked filing cabinet. Computer files will be secure and 
password protected.  
 
10.2 Data Management 
 
We will employ our time- tested procedures for interview data collection and 
quality control, scanning self-administered forms or using double key entry verification 
of paper forms or to minimize data collection errors during baseline and follow-up 
interviews. If possible, self-report interview data will be collected in –person and 
inspected for completeness before the participant leaves to minimize errors.  We will 
employ our standard quality control procedures to ensure that data collection is 
proceeding smoothly, electronic data are password protected and paper forms are 
stored in locked filing cabinets to ensure confidentiality of information.  
 
 
We will implement procedures to ensure that all data collection processes are 
proceeding smoothly.  These procedures will ensure that randomization is proceeding 
as planned, recruitment is on schedule, data collection forms are accurately entered into 
databases, the database is storing data correctly and that data can be accurately 
transferred and retrieved as needed. We will develop a relational database to track 
information on every stage of recruitment, randomization, class attendance, and 
outcomes assessment so we can report patient flow automatically and in an integrated 
fashion using standard, automated reports.   All data system processes will be 
thoroughly tested prior to the start of recruitment.  
 
All questionnaire databases will contain range and logic checks.  Participant 
attendance information collected during the classes will be double key entered into a 
computer database that also contains logic checks.  Prior to recruitment, all data 
systems will be tested with imaginary participants.  Data will be examined for 
completeness using computer programs developed specifically for that purpose.  In 
addition, we will test all analytic programs to ensure that the analyses are accurate.  
Computer files with participant names will be password protected with access restricted 
to staff using this information to recruit participants, contact class participants or obtain 
follow-up data, and interact with any patients reporting adverse events.  Any paper data 
forms, such as homework logs, identifiable only by unique study ID numbers, will be 
kept in locked filing cabinets. Finally, all analysis data files will be password protected.  
Full data backup procedures are performed nightly, with partial data back-up throughout 
the day. 
 

Page 37 of 47 
10.3 Quality Assurance 
10.3.1 Training 
 
All study staff will have had prior experience with RCTs, will have been trained in 
Good Clinical Practice Guidelines, and will be trained specifically on the procedures for 
this trial. A study Manual of Operations will be created that details the procedure for 
each element of the study implementation. Prior to the start of recruitment, the study 
team will participate in training sessions with mock participants to ensure an 
understanding of all study procedures and consistency in application.  
 
10.3.2 Protocol Deviations 
 
Protocol deviations will be captured through weekly review of study recruitment 
and follow-up reports and through routine bi-weekly data checks of study data being 
collected, entered, and stored in our study databases. The weekly review of study 
recruitment and follow-up reports will be conducted by PI, Sherman and Project 
Manager Hawkes. The bi-weekly data check of the study databases will be performed 
by the programmer and reviewed by PI Sherman and Project Manager Hawkes. In 
addition, study staff responsible for conducting these activities will meet with Project 
Manager Hawkes on a weekly basis to discuss study progress and any potential 
violations that may have occurred. Protocol violations will be reported to the Kaiser 
Permanente Washington IRB as a part of the annual continuing review report. In 
addition, protocol violations will be reported to the Independent Monitoring Committee 
as a part of the reports completed every six months during active recruitment, 
intervention, and follow-up periods. 
 
10.3.3 Monitoring 
Project Manager Hawkes will meet with study staff responsible for conducting RCT 
activities on a weekly basis to discuss and review recruitment, intervention and follow-
up activities. A study data quality assurance (QA) tracking file will be created in EXCEL 
and will be used to track adherence to the study protocol. Examples of elements 
including on the QA tracking file are: confirmation of signed consent form, confirmation 
of home practice logs (for those randomized to Tai Chi), and attendance information. 
The study QA tracking file will be completed by our study research specialists and will 
be reviewed by Project Manager Hawkes. Any protocol deviations will be shared with PI 
Sherman and will be reported to the Kaiser Permanente Washington IRB and our study 
DSMBody at the next regularly scheduled reporting period. In addition, our study 
programmer will run data QA checks to ensure that study data being collected is 
complete and accurate. Any abnormalities in data will be immediately reported to PI 
Sherman and Project Manager Hawkes so that a solution can be created.     
 
11.  ETHICAL PRINCIPLES 
11.1 Institutional Review Board  
The investigators are responsible for obtaining initial and continuing review (at 
intervals of not less than yearly) of the study by their IRB. Written approval from the IRB 
will be on file prior to commencement of study activities.  All study personnel have 
Human Subjects Research Training certification on file with the IRB, including Good 
Clinical Practice training 

Page 38 of 47 
 
11.2 Informed Consent:  
 
Kaiser Permanente Washington members who are have received an invitation 
letter to the study and are interested in participating will sign and return a statement 
indicating their willingness to be contacted by study staff. A toll-free study line will also 
be included for potential participants who prefer to contact study staff via telephone. A 
Research Specialist will then phone interested enrollees to answer questions, obtain 
oral consent for an initial telephone eligibility screen and determine preliminary eligibility 
using a computer program to guide the interviewer through a series of screening 
questions. The screening process ends with documentation in a database of either 
preliminary eligibility or ineligibility. Once a potential participant has been deemed 
preliminarily eligible, they will be scheduled to attend one of our in-person group 
eligibility screening and assessment visits at a Kaiser Permanente Washington Medical 
Center. While the in-person visits are in a group setting, physical assessments, 
informed consent, and randomization will take place in a private room adjacent to the 
group area. During the group assessment visit, eligibility will be confirmed through 
completion of a final eligibility screening (e.g. demonstration of sufficient mobility, willing 
ness to be randomized). If the participant is deemed eligible and is willing to participate, 
informed consent will be administered by a study Research Specialist. This will include 
an explanation of interview time commitments and content, intervention commitments 
(class attendance, home practice, and home practice diary completion), potential risks 
of participation, potential benefits of participation, what to do for an adverse event, and 
options for discontinuation of participation in the study.  The Research Specialist will 
also explain the handling of data and personal health information as dictated by HIPAA. 
Signed consent forms will be kept at the Kaiser Permanente Washington Research 
Institute in a locked filing cabinet only accessible by the appropriate study staff.  
 
11.3 Health Insurance Portability and Accountability Act (HIPAA)  
Kaiser Permanente Washington has instituted a protocol that ensures research is 
conducted in compliance with the federal law entitled, “Health Insurance Portability and 
Accountability Act (HIPAA)”.  Permission to use, create, and release personal health 
information for research will be obtained before potential participants can be enrolled in 
this study.  One of the study Research Specialists will explain HIPPA as it relates to this 
research study to potential participants to ensure that they understand it and have the 
opportunity to ask any questions pertaining to their personal health information as it 
relates to this study.  This process will explain what is meant by health information, how 
health information is obtained, how the researchers may use health information, and 
detail the steps a participant must take if s/he decides to revoke this permission.   
 
11.4 Confidentiality of Participant Records 
The investigators and their study teams will maintain strict confidentiality of the 
participant records. Individual records will be identified by a unique study identification 
number. Records linking study ID with participant names or other identifying information 
that may be needed for follow-up interviews, class attendance, etc. will be kept separate 
from the study data and will be accessed only by study team members on a need-to-
know basis. All study files will be kept in a locked filing cabinet. Computer files will be 

Page 39 of 47 
secure and password protected. Any information about any participant will not be 
released without the written permission of the participant, except as necessary for 
monitoring by the KPW IRB, the NCCIH and the OHRP.  
 
11.5 Study Discontinuation 
 
The study may be discontinued at any time by the KPW IRB, the NCCIH or the 
OHRP as part of their duties to ensure that research participants are protected.  
 
12.  ORGANIZATION AND ADMINISTRATION 
12.1 Funding and Organizational Oversight 
The Back Tai Chi study would be a two year single-site clinical trial funded as an 
R34 by the National Center for Complementary and Integrative Health (NCCIH).  The 
NCCIH Project Officer assigned to this project would provide NCCIH oversight on the 
project. A specially-created Safety Monitoring Body will ensure the safety and welfare of 
patients enrolled in this trial.  Budgetary oversight will be provided by NCCIH staff.  The 
study would be reviewed and approved by NCCIH’s Office of Clinical and Regulatory 
Affairs.   
 
12.2 Organizational Structure  
Administrative Leadership is based at the Kaiser Permanente Washington Research 
Institute in Seattle.  Overall scientific and administrative responsibility for the project 
resides with Dr. Karen Sherman, the Principal Investigator. Ms. Rene Hawkes, Project 
Manager, is responsible for day-to-day project administration, human resources issues, 
correspondence with the IRB, supervision of study staff, and coordinating liaison with 
the Tai Chi class instructor(s).  Dr. Sherman and the Programmer will have 
responsibility for ensuring data integrity.  The Safety Monitoring Body will have 
responsible for ensuring the safety of study participants. 
 
Biostatistician Wellman will ensure that the project team is aware of relevant 
statistical issues that could affect study design, will create the randomization scheme, 
analyze the data and anticipate the needs of a large RCT.  Project Manager Hawkes will 
have responsibility for preparation of materials for the IRB, for hiring and supervising 
project staff, and for maintaining the budget. There will be monthly meetings of all team 
members, and weekly meetings of those team members actively involved in the specific 
activities underway at the time. 
 
13  PUBLICATION POLICIES AND PROCEDURES 
     The Principal Investigator has responsibility for developing and maintaining a list of 
proposed publications including topic, names of the primary authors and date proposed.  
It is the first author’s responsibility to determine who will be listed as co-authors and in 
what order.  We will follow the International Committee of Medical Journal Editors’ 
guidelines on authorship on all manuscripts deriving from this study. “Publications” will 
be a standing item on the agenda for team meetings to ensure open and frequent 
discussion of this issue.  The P.I. will be first author on the primary manuscript, but first 
authorship on all other manuscripts will be shared. 
 

Page 40 of 47 
14 STUDY TIMELINE: MILESTONES 
The proposed study timeline is shown below for the feasibility study.  The 
Administrative Year, during which the protocol will be finalized, all other study 
documents created, and approvals obtained from the GH IRB, the NCCIH Office of 
Clinical and Regulatory Affairs, and the Independent Monitoring Committee is not 
shown. However, all approvals will be obtained before the study is started. 
 
TASK 
COHORT 1 
COHORT 2 
Recruit, randomize, collect baseline data 
Month 1-4 
Month 5-8 
Conduct Standard Tai Chi classes 
Month 5-8 
Month 9-11 
Conduct Maintenance Tai Chi Classes 
Month 8-13 
Month 12-17 
Collect 12 week follow-up data  
Month 8-9 
Month 12-13 
Collect 26 week follow-up data  
Month 11-12 
Month 15-6 
Collect 52 week follow-up data  
Month 17-18 
Month 21-22 
Conduct debriefing discussion groups 
Month 17-18 
Month 21-22 
Analyze data 
Month 20-23 
Prepare report, manuscripts, grant proposal 
Month 22-24 
 

Page 41 of 47 
 
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Appendix A: Kaiser Permanente Washington IRB (Human Subjects Review Committee – HSRC) 
Reporting Requirements related to Adverse Events 
 
  
Principal Investigator Reports  
to HSRC: 
Report 
Within 1 
Business 
Day 
Report within 15 
Days of Rect  
or before next 
HSRC Meeting 
Deadline 
(whichever  
is first) 
Report at PI 
Discretion 
Summarize 
at 
Continuing 
Review 
Adverse Events (AE)  
Unexpected death of research participant 
that is at least possibly related to the study
  
  
Unexpected death of research participant 
that is not related to the study  
  
  
  
Adverse Events which are unexpected, 
serious, and at least possibly related to the 
study—(these AE’s also represent 
Unanticipated Problems) 
  
 
  
 
Unexpected and serious, but definitely not 
related to the study, and not an 
Unanticipated Problem  
  
  
  
 
Serious Adverse Events that are expected 
(see definition) in some subjects, but are 
determined or suspected to be occurring at 
a significantly higher frequency or severity 
than expected. 
  
 
  
 
Expected (see definition) adverse events, 
serious or not serious, at least possibly 
related, not occurring at a higher frequency 
or severity than expected 
  
  
  
 
Any event leading to the PI’s concern 
regarding health, safety, or rights of 
research participants  
  
 
  
 
Other Unexpected Adverse Events, 
regardless of severity, that may alter the 
HSRC’s analysis of the risk versus 
potential benefit of the research because 
they suggest that the research places 
subjects or others at greater risk of 
physical or psychological harm than was 
previously known or recognized and, as a 
result, may warrant consideration of 
substantive changes in the research 
protocol or informed consent process / 
document. 
  
 
  
 
Summarize ALL Adverse Events (whether 
previously reported to HSRC or not) at 
  
  
  

Page 47 of 47 
time of yearly continuation review) 
If DSM Body determines that an Adverse 
Event that was not previously reported to 
the HSRC, is now determined to also 
represent an Unanticipated Problem (for 
example due to increased frequency), then 
the Investigator must report it promptly to 
the HSRC.  Include the monitoring entity’s 
report with any actions taken with the 
submission to the HSRC.  In addition, 
summarize the event(s) at time of 
Continuing Review.