Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel
Phase: NA
Conditions: Chronic Low Back Pain, Chronic Neck Pain
Sponsor: University of California, San Diego

 
 
 
 
 
STUDY PROTOCOL 
 
 
Yoga for Active Duty Military with CLBP and/or CNP 
 
 
 
Erik J. Groessl, PhD, Principal Investigator 
 
VA San Diego Medical Center 
3350 La Jolla Village Dr. #111 N-1 
San Diego, CA 92161 
 
Professor 
Department of Family Medicine and Public Health 
University of California San Diego 
858-642-6347 
 
Sponsored by: NIH/NCCIH  
Grant # 5 R34 AT009073-03 
07/01/2016 – 05/31/2020 
 
UCSD IRB# 16-0341X - Approved 03/01/2019 

 
 
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UCSD Human Research Protections Program 
New Biomedical Application 
RESEARCH PLAN 
Instructions for completing the Research Plan are available on the HRPP website. 
The headings on this set of instructions correspond to the headings of the Research Plan. 
General Instructions: Enter a response for all topic headings.  
Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. 
 
1. 
PROJECT TITLE 
Yoga for Active Duty Military with CLBP and/or CNP 
2. 
PRINCIPAL INVESTIGATOR  
Erik J. Groessl, PhD 
Associate Professor and Center Director 
UCSD Health Services Research Center 
Dept. of Family & Preventive Medicine 
University of California San Diego 
9500 Gilman Dr., #0994 
La Jolla, CA 92093 
858-642-6347; egroessl@ucsd.edu 
 
3. 
FACILITIES 
UCSD’S Health Services Research Center 
5440 Morehouse Drive, Suite 3500 
San Diego, CA 92121 
(858) 622-4050 
 
Yoga of Oceanside 
1830 Oceanside Blvd., Suite E 
Oceanside, CA 92054 
 
Naval Medical Center San Diego (NMCSD) 
34800 Bob Wilson Dr. 
San Diego, CA 92134 
 
4. 
ESTIMATED DURATION OF THE STUDY 
Three years. 
 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with 
Chronic Low Back Pain (CLBP) or Chronic Neck Pain (CNP). In addition, we will evaluate the yoga intervention 
preferences and refine an existing yoga intervention to address those needs. The study will be conducted in two phases: 
Phase 1 involves collecting qualitative data on the style of yoga that most appeals to military personnel with CLBP, 
obtaining military IRB approval, and modifying the existing yoga intervention. Phase 2 includes recruitment and 
randomization of 60 military personnel with CLBP to active yoga or to restorative yoga. This will be conducted at two 
sites, one at NMCSD and one at Yoga Oceanside. (Please note:  before we begin Phase 2 we will also need to obtain 
IRB approval from NMCSD for activities that will take place at that site.  Once we obtain IRB approval from 
NMCSD, we will provide a copy to UCSD’s IRB prior to commencing any activities at that site.)  Participants will 
complete assessments at baseline and end of interventions (12-weeks).  Phase 1 will be completed over the first 12 
months of the 36-month project. Phase 2 will be completed over the remaining 24 months. Pain interference will serve as 
the primary outcome with physical function and pain severity serving as important additional outcomes. The study will 

 
 
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prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military. 
 
6. 
SPECIFIC AIMS 
Phase 1 -  includes Aims 1-3 and involves obtaining military IRB approval, using qualitative methods to understand the 
yoga preferences and attitudes of military personnel with CLBP/CNP, and refining the existing VA yoga intervention to 
better suit active-duty military personnel.  
• 
Aim 1: Assess and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled 
intervention studies with active-duty military personnel. 
• 
Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel 
with CLBP/CNP. 
• 
Aim 3: Modify an existing yoga intervention for the preferences of active-duty military and to address both CLBP 
and CNP. 
 
 
Phase 2 –we will accomplish Aims 4-6 by conducting a pilot randomized control trial (RCT) of yoga and a health education 
self-care control intervention. 
• 
Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP. 
• 
Aim 5: Evaluate adherence to the yoga interventions. 
• 
Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT.   
 
7. 
BACKGROUND AND SIGNIFICANCE 
Chronic low back pain (CLBP) and chronic neck pain (CNP) are highly prevalent conditions that become chronic in 20-
30% of those afflicted.1 In addition to pain, CLBP and CNP are associated with decreased functional ability,2 work 
absence,3,4 increased psychological symptoms, (depression,5,6 anxiety7,8) and higher health care costs.9 Military 
personnel10,11 and veterans12 have higher rates of CLBP/CNP than the general US population, and CLBP/CNP are two of 
the most common reasons for disability among deployed personnel11 and the military in general.13 CLBP/CNP in military 
personnel are often exacerbated by co-morbidities14,15 that pose additional challenges and can interfere with treatment. 
Recommended treatment for CLBP/CNP begins with medication management and self-care instruction,16 but the limited 
effectiveness of these approaches and risks associated with pain medication creates a need for non-pharmacologic 
approaches.17,18 Of the non-pharmacological approaches, none have large effects for CLBP/CNP.  Because yoga can 
benefit health much more broadly and has few side effects, it is an increasingly valued care option among military 
personnel.19,20 
Yoga interventions involve the integration of physical postures and movement, deep breathing, and focused attention. 
Thus, yoga interventions are multifaceted, with documented physical and psychological benefits including a) increased 
strength, flexibility, and conditioning through the performance of physical postures, and b) stress reduction/ relaxation 
and improved psychological functioning facilitated by deep breathing exercises, concentration/ attention, and cognitive 
strategies.  
Although the evidence for yoga as a treatment for CLBP was rated as “fair” in 2007 clinical guidelines,18 two more recent 
large RCTs provide strong evidence that yoga reduces pain and disability among persons with CLBP.21-23  However, none 
of these studies were conducted in military populations. PI-Groessl has conducted preliminary studies showing that VA 
patients with CLBP/CNP will attend yoga sessions and that yoga improved their pain, physical function, and other 
outcomes.24,25 He is currently finishing a full-scale RCT of yoga for CLBP/CNP in the VA system and collaborates on a 
similar NCCIH project with Dr. Rob Saper. However, military personnel with CLBP/CNP10 are on average, much 
different than VA patients with CLBP/CNP26. They are considerably younger and more active, have different co-
morbidities and career objectives, and require different treatment strategies. Creating interventions that can treat more 
than a single condition is also needed. Health organizations cannot easily offer a long menu of yoga interventions, each 
designed for a specific health condition. Our pragmatic clinical trial approach will address this barrier by designing an 
intervention to address two common and similar spinal conditions and compare two different styles of yoga in one study.  

 
 
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8. 
PROGRESS REPORT 
N/A 
 
  
9. 
RESEARCH DESIGN AND METHODS 
Overall 
This is a pilot study with an objective to examine the feasibility and acceptability of conducting a yoga RCT among 
active-duty military personnel with CLBP/CNP in military and community settings. The subject population will consist of 
80 adults, 70-75 active-duty military personnel with chronic low back pain (CLBP) or chronic neck pain (CNP) and 5-10 
yoga instructors or healthcare providers who have provided yoga or care for active-duty military personnel with CLBP or 
CNP. The study will be conducted in two phases: Phase 1 will involve obtaining IRB approval to conduct research in 
military settings, collecting qualitative data from stakeholders on attitudes and preferences for yoga interventions, and 
refining the existing Yoga for CLBP intervention for the needs of active-duty military and persons with CNP. Phase 2 
will recruit and randomize 50 military personnel with CLBP or CNP to either active hatha or restorative yoga. Pain 
interference, pain severity, physical function, opioid medication use, and mental health outcomes are of primary interest. 
Mechanisms will also be studied. 
 
Phase 1  
Phase 1 includes Aims 1-3 and involves obtaining military IRB approval, using qualitative methods to understand the 
yoga preferences and attitudes of military personnel with CLBP/CNP, and refining the existing VA yoga intervention to 
better suit active-duty military personnel.  
 
Aim 1: Assess and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled 
intervention studies with active-duty military personnel. To achieve Aim 1, we will partner with Dr. Ian Fowler and Dr. 
Jeffrey Millegan from the NMCSD as described above. Both Dr. Fowler and Millegan are researchers /clinicians with 
experience obtaining IRB approval at NMCSD. Dr. Fowler has a research nurse with experience assembling the required 
IRB documents. They will work closely with Dr. Groessl and the UCSD Project Coordinator to meet NMCSD military 
IRB requirements, starting as soon as the study has been funded. We expect the military IRB approval process to take 
approximately 6 months to complete. Yoga is not viewed as high risk or experimental given that it has been well studied 
elsewhere and few adverse events have been documented21. However, to be conservative, we have allotted up to 12 
months for military IRB approval and Phase I activities can fully proceed under UCSD IRB approval.  
 
Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with 
CLBP/CNP.  30 total Qualitative Interviews will be conducted with military personnel with CLBP or CNP and with 
healthcare providers who provide yoga or other healthcare to military personnel with CLBP or CNP.   
 
Qualitative Interview Methods:  
The proposed qualitative component of the study is both exploratory and inductive in nature. Semi-structured 
qualitative interviews will be employed to explore the participant preferences and experiences with yoga in relation to 
their CLBP/CNP.  This information will contribute to the refinement of an existing yoga intervention for veterans 
with CLBP so that it is optimal for active-duty military personnel. Interview techniques will use open-ended questions 
to stimulate a wider range of responses for a more complete understanding of the needs and attitudes encountered by 
study participants. Interviews are expected to last about 60 minutes in length. Open-ended questions during the 
interviews will address: 1) past experiences with non-pharmacological treatments for CLBP/CNP; 2) past experiences 
with yoga; 3) a brief presentation of the existing yoga program; 4) preferences in regard to the emphasis given to the 
various components the yoga intervention such as postures, pace of transition through poses, breathing techniques, 
meditation, ethical principles and spiritual aspects; 5) dosing of yoga; and 6) discussion of research participation and 
burden given military schedules. Interviews with yoga providers and other health care providers will follow the same 
set of questions but will ask for both their own preferences as a clinician and their perspective on how their patients 

 
 
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might typically respond. Of the 30 interviews, we will interview 8-10 participants with CLBP/CNP who have never 
done yoga. Those interviews will employ slightly different questions that are designed to elicit attitudes, beliefs, and 
perceptions about yoga as a treatment modality for CLBP/CNP in military personnel, and barriers to participation. 
Instead of a question about their past experiences with yoga, they will be asked to provide their perceptions of yoga as 
a treatment modality and any barriers or facilitators that may affect their future participation. All qualitative 
interviews will be digitally audio-recorded and digital tapes will be encrypted before being confidentially submitted to 
a transcription consultant to transcribe the audio recordings verbatim for the purpose of coding and analysis. All 
names and locations mentioned during the course of the interviews will also be removed from the final transcripts 
prior to analysis.  
 
Qualitative Data Analysis:  
A salient strength of qualitative analysis is its focus on the context and meaning of human experience for the purpose 
of inductive and exploratory-driven research. Qualitative methods facilitate the collection of data when exact 
measures do not exist. Transcribed summaries from the interviews will be analyzed using directed content analysis 
(DCA) to identify and categorize meaningful and detailed information about participant’s opinions, perceptions and 
experiences participating in the mindfulness meditation intervention. Coding strategies will include highlighting 
passages for emergent themes and also a priori categories reflecting questions from the interviews. Through this 
process and the comparison of new data, a template of open codes will be constructed to analyze all of the transcripts 
in accordance with standard qualitative analytic convention. Verification of emergent themes from interviews will be 
examined through investigator discussions of the coding framework. Disagreements during theme interpretation or 
coding hierarchy will be resolved early on through investigator discussions before completing the qualitative analysis. 
 
Aim 3: Modify an existing yoga intervention for the preferences of active-duty military and to address both CLBP and 
CNP. Based on the results of the qualitative interviews, the existing yoga intervention designed for VA patients with 
CLBP will be refined and adjusted to better fit the preferences of active-duty military personnel with CLBP or CNP. This 
process will start with the investigators and yoga experts reviewing Dr. Hurst’s report of the qualitative results. The team 
will also independently review a current Yoga for CLBP manual being used by Dr. Groessl, the Cramer et al. manuscript 
which lists the 14 yoga poses they selected for treating CNP, and other yoga texts. Investigators and experts will then 
convene at UCSD for an extended afternoon meeting to select of a pool of possible poses. The PI will then work with 
orthopedic surgeon Dr. Chang and yoga expert Dr. Schmalzl to propose specific changes to the intervention. The 
revisions will be presented to the other collaborators for review and additional discussion. Possible examples include a 
slightly faster pace, adding postures for additional challenge for those with less impairment (yet easily modified to be safe 
for all), additional attention tasks or imagery, and further trauma sensitivity. All changes and the rationale behind them 
will be documented. 
 
Phase 2 
Please note:  before we begin Phase 2 we will also need to obtain IRB approval from NMCSD for activities that 
will take place at that site.  Once we obtain IRB approval from NMCSD, we will provide a copy to UCSD’s IRB 
prior to commencing any activities at that site.  In Phase 2 we will accomplish Aims 4-6 by conducting a pilot RCT 
with 2 yoga interventions.  We will recruit 25 people at each of two sites, one in a military medical facility (NMCSD) and 
one in a community yoga studio (Yoga Oceanside) near a large military base for a total of 50 participants. Once 25 people 
have been recruited at each site, they will be randomized to attend either active hatha yoga or restorative yoga.     
 
Screening and Inclusion/Exclusion Criteria.  
50 active-duty military personnel with CLBP will be recruited and randomized to either active hatha yoga or to 
restorative yoga. Inclusion criteria are as follows: 
Inclusion: 
• 
Diagnosis of CLBP or CNP > 6 months 
• 
Willing to attend a yoga program for 12 weeks  
• 
Willing to complete 3 assessments 
• 
English literacy 
• 
Have had no changes in pain treatments in the past month 

 
 
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• 
Willing to not change pain treatments during study unless medically necessary 
• 
Have not practiced yoga more than 2x in the last 12 months 
Exclusion: 
• 
Back or neck surgery within the last year 
• 
Back or neck pain due to specific systemic problem (e.g., lupus, scoliosis) 
• 
Severe vertebral disk problems,  
• 
Persistent sciatica or nerve compression > 3 months 
• 
Coexisting chronic pain problem (e.g., migraine headaches, fibromyalgia) 
• 
Serious or unstable psychiatric illness (e.g., psychosis, mania, episode, or substance dependence)  
• 
Major coexisting medical illness (e.g., cancer, COPD, morbid obesity) 
• 
Positive Romberg test (with or without sensory neuropathy) 
 
No other exclusion criteria will be employed. No special classes of subjects or other vulnerable populations will be 
recruited. We will make efforts to recruit at least representative proportions of women and racial and ethnic minorities. 
More detail is provided on the inclusion of women and minorities document in this application. 
 
Table 4. Inclusion / Exclusion Criteria with Method used to Determine Eligibility for Study Participation 
Inclusion Criteria 
Determined by: 
 
Exclusion Criteria 
Determined by: 
Active-duty military 
employment and age > 18 
screening interview; 
medical record 
 
back or neck surgery within the last 1 
year 
screening interview; 
medical record 
Diagnosis of chronic low back or 
neck pain > 6 months 
screening interview; 
medical record 
 
back or neck pain due to specific 
systemic problem (e.g., lupus) 
screening interview; 
medical record 
Willing to attend 12-weeks of 
yoga  
screening interview; 
informed consent 
 
severe vertebral disk problems 
screening interview; 
medical record  
Willing to complete 2 
assessments 
screening interview; 
informed consent 
 
persistent sciatica or nerve compression 
> 3 months 
screening interview; 
medical record  
English Literacy 
 
screening interview; 
informed consent  
 
coexisting chronic pain problem 
(migraine headaches, fibromyalgia) 
screening interview; 
medical record 
No changes in pain treatments in 
the past month. 
medical record; 
screening interview 
 
Serious or unstable psychiatric illness 
(e.g. psychosis, mania)  
screening interview; 
medical record 
Willing to not change pain 
treatments during study unless 
medically necessary. 
screening interview; 
informed consent 
 
major coexisting medical illness (e.g., 
cancer, COPD, morbid obesity) 
screening interview; 
medical record 
Have not practiced yoga > 2x in 
the last 12 months 
screening interview; 
informed consent 
 
Positive Romberg test (with or without 
sensory neuropathy) 
screening interview; 
medical record 
 
Recruitment staff will meet with participants to obtain informed consent and HIPAA authorization before a screening 
visit. Potential participants will undergo a physician screening exam to ensure they meet the study inclusion/exclusion 
criteria and can participate safely. Screening will be performed by Dr. Fowler at NMCSD or by Dr. Chang at UCSD for 
the community site and includes a review of the patients’ medical record, a brief interview, and a physical examination. 
Inclusion/ exclusion criteria and the sources of information used to determine them are listed in Table 4. Patients who 
have recently changed any professionally-delivered pain treatment (e.g., medications, chiropractic) are not eligible until 
their treatment has been stable for 30 days. Participants are asked to keep all pain treatments stable during the 12-week 
intervention period unless a change is medically necessary and their agreement and study participation are documented in 
their medical record. Staff will assess all treatments including non-prescription medication use and any treatment changes 
that do occur through self-report assessment at 4-weeks, 8-weeks, and the end of the 12 week study period. Participants 
are asked take their lowest usual dose of pain medications within 24 hours of each assessment. Although we will exclude 
those with serious or unstable psychiatric  illness, we expect to enroll many patients with stable levels of depression, 
anxiety (including PTSD), substance use, etc. as these conditions are prevalent and contribute to disability among 
CLBP/CNP patients. Research suggests that yoga has beneficial effects on psychiatric symptoms. We will exclude 
patients who report active suicidal ideation at baseline or have recent suicide attempts.  
 

 
 
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Assessments and Randomization:  
All eligible participants will be scheduled for assessments at two time points: pre (baseline) and post intervention (12-
weeks).  The assessments consist of a battery of 8-10 questionnaires taking about 20-30 minutes to complete. Next, 
physiological measurements will be conducted by a trained research assistant and will take about 10 minutes to complete.  
Participants will receive $30 for completing each assessments. Completed questionnaires will be coded with a study ID to 
protect confidentiality. All personal health information will be entered into a password protected secure server 
environment within UCSD-HSRC. After the baseline assessment, participants will be randomized to either the Hatha 
Yoga Intervention or to the Restorative Yoga Intervention. Randomization will occur through a web portal linked to a 
secure file providing block randomized digits that was prepared by the study statistician. There will be one block file for 
each site, with 30 digits in each file, allowing each site to have a balanced randomization. Research staff will not have 
access to the randomization file. Participants will be told of their group assignment and will be allowed to ask additional 
questions at that time. 
Assessment Questionnaires and Measurements: 
Screening:  Medical record information will be used by screening physicians to complete the Back Pain History 
Questionnaire which will allow the investigators to assign a descriptive diagnosis based on the Quebec 
Nomenclature on Activity Related Spinal Disorders104. The measure has been used in previous VA studies105-107. 
Additional information on co-morbid diagnoses, opioid pain medication usage, and ongoing treatments will also 
be collected including information on TBI, PTSD and other psychological diagnoses, and substance use. 
Demographics:  A brief questionnaire will assess age, gender, education, race/ethnicity, employment status, military 
rank and duties, and combat status.  
Pain interference with daily function and pain severity will be measured with the short version of the Brief Pain 
Inventory (BPI).108 Pain interference will serve as the primary outcome. The BPI has been validated with 
CLBP.109 The pain interference score is the mean of the 7 interference items. The pain severity score is the 
mean of 4 severity items. The BPI has good reliability (alpha 0.77 - 0.91).  
Disability/Physical Function. The Roland-Morris Disability Questionnaire consists of 23 questions that ask about 
limitations experienced for a variety of daily activities. The scale has been shown to be reliable and is well 
validated110. It has been used in other studies of yoga studies102. The Neck Disability Index will be used to 
assess disability related specifically to neck pain. It is a well validate measure.111  
Depression. Derived from the full  Center for Epidemiologic Studies Short Depression Scale112 (CES-D), the CES-
D 10113 consists of 10 items on the frequency of mood symptoms. Scores > 10 indicate depression.  
Anxiety.  The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms and consists of 21 items. 
The BAI was developed with psychiatric outpatients114 and has good reliability and validity.115 
HRQOL.  The Short-form 12 (SF12) was derived the SF-36.116 The PCS-12 and MCS-12 have been shown to be 
similar to the SF36 levels of precision and sensitivity to change. 
Self-efficacy. Self-efficacy for managing pain reflects confidence in the ability to influence the intensity or  impact 
of CLBP/CNP on daily life. The questions are based on items developed by Lorig et al.117.  
Fatigue. The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of > 4.0 
constitutes severe fatigue.118 The measure has good psychometrics for pain disorders.118,119 
Attendance/ Home practice.  Attendance of yoga sessions will be assessed using sign-in logs verified by the yoga 
instructor. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The 
yoga log assesses the amount of time practiced, the use of instructions, the difficulty of poses, and the estimated 
level of exertion. 
Acceptability and Satisfaction Questions. We will assess program acceptability and satisfaction using 10 questions 
developed and used by the investigators in previous and current yoga studies. The questions will gauge factors 
affecting attendance and participation levels. 
Patient Expectations will be measured at baseline to determine whether the descriptions of the yoga interventions 
could result in different expectations for improvement. Dr. Karen Sherman will use the new patient expectation 
measure developed by her and her colleagues.120 
Physical Measures. The integrity of physiological measure will be maintained by having multiple research staff 
trained by local UCSD experts in the use of the inclinometer, dynamometer, heart monitors, and core strength 
tests. Following initial training, research staff will conduct a series of 6 mock measurements to ensure 
reliability of measurement. Any problems will be tracked and addressed with re-training.  
Spinal Range of Motion (ROM) will be measured using a digital inclinometer, which isolates lumbar 

 
 
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ROM (flexion and extension). The device uses a precise optical angular scanner placed along the 
spine. Device error is negligible with accuracy as high as 98%121 The device has been used in other 
yoga interventions.103 
Grip Strength will be measured using two trials for each hand with a hydraulic dynamometer. The best 
performance is selected for each side, and the average of the left and right hand is used for analysis. 
Painful or injured hands or wrists are not tested and the result of the good hand is used. Reliability 
has been shown to be high: r=0.88-0.92. Good predictive validity of grip strength has been shown for 
disability and mortality.122 
Core Stabilization and Strength.  Prone and supine bridge positions will assess core stabilization.123 
Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The 
supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with 
shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each 
position is held in proper form.  
Heart rate. Physical exertion during yoga will be measured using Polar FT4 Heart Rate Monitors. Worn 
on the chest, they provide aggregate summary data such as maximum and mean heart rate during a 
workout. 
 
 
Interventions: 
There will be two interventions: Hatha Yoga and Restorative Yoga. Both interventions will meet 2 times a week for 12 
weeks with at least one day of rest between each class. Individual classes will be 60 minutes long and led by a certified 
yoga instructor. Additionally, participants will be encouraged to practice yoga at home as guided in a home practice 
manual. 
 
Hatha Yoga (HY) 
     Using information gathered during qualitative interviews in Phase I, the yoga intervention will be tailored to our 
target population. However, we do not anticipate significant changes to the existing yoga protocol for CLBP that was 
developed for Dr. Groessl’s current study, Yoga for CLBP being conducted with veterans. Our team of experienced 
yoga instructors will also adapt the existing CLBP yoga intervention to be safe and effective for CNP. Our team 
consists of co-investigator Dr. Laura Schmalzl (researcher and experienced yoga instructor), Camilla Sinclair (current 
instructor of Yoga for CLBP at VASD), Danielle Fowler (owner of Yoga Oceanside), and Betty Michalewicz 
(military yoga instructor at NMCSD Wellness Program). We will also consult Anatomy of Hatha Yoga79 and Yoga as 
Medicine which has a useful section on avoiding neck injuries.93  Poses known to put pressure on joints, muscles, or 
nerves in the neck such as head stands, shoulder stands including plow and other variations will not be used. 
The HY intervention will be led by a certified instructor at each site. Both instructors will be trained by Camilla 
Sinclair who has been practicing yoga for over 16 years and has over 8 years of teaching experience and is the main 
instructor for Dr. Groessl’s Yoga for Vets with CLBP.  (NOTE:  We will model the HY intervention after the current 
Yoga for CLBP intervention which is a classical hatha yoga with influences from Viniyoga and Iyengar yoga.  Both 
Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps 
and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and 
limitations.)  The certified yoga instructors will lead participants through a series of 23 yoga poses (32 total 
variations) at a slow-moderate pace. Instructors will be asked to follow the manual which will help standardize the 
yoga intervention. The manual contains pictures and a description of how to perform each pose with typical instructor 
dialogue. The dialogue may be paraphrased and varied slightly, yet promotes more consistent replication and 
generalization of results. The manual includes some poses that could aggravate back conditions if they are not 
modified for some people. That is why multiple modifications are shown and many of the poses shown are only 
worked up to after weeks of practice and individual attention from the instructor. The more challenging poses are not 
included in the home practice manuals. The importance of attending all sessions will be stressed during session 1 and 
throughout all sessions. Participants who miss a session without notifying the instructor will be contacted to check on 
the reason for non-attendance. Participants will also receive a home practice manual containing some basic, safe 
postures that can be performed in 10-15 minutes on days they will not be attending the formal in-person sessions.  
Participants will be encouraged to not push themselves as much when practicing at home and to stop when pain or 
discomfort becomes noticeable. They will be encouraged to consult with the instructor individually before and after 

 
 
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class about any problems or difficulties they are encountering at home or in the formal sessions. 
During the formal sessions, participants will be instructed to take slow, deep breaths in conjunction with specific 
phases of poses. Participants will be encouraged to emulate the optimal alignment being demonstrated by the 
instructor. In addition, participants will be encouraged to focus on a goal or positive direction for their yoga practice. 
The yoga classes are constructed to allow optimal flow from one pose to another. Each 60-minute session will begin 
with a few minutes of deep breathing and mindfulness/meditation followed by about 15 minutes of basic postures 
(Poses 1-8) to warm-up the muscles/body by increasing circulation, providing more flexibility as the class progresses. 
Most poses will be conducted once to each side or with the opposite foot leading. After warming-up, the instructor 
will lead students through a series of standing poses (Poses 9-14) which include balance for about 15 minutes. After 
the standing poses, the class will move into floor poses (Poses 15-22) for about 20 minutes. Each session will end 
with about 5-7 minutes of complete relaxation in the standard ending pose “savasana”. At this time, additional 
positive mental suggestions/affirmations will be provided. 
 
Restorative Yoga (RY)  
     RY will serve as the comparison intervention but is also of interest in itself as a possible treatment modality. For 
the purposes of this pilot study (R34 proposal), we are using the term “Restorative Yoga” to refer to yoga 
interventions that emphasize relaxation and include very little movement, and are non-strenuous. RY sessions 
typically include only 5-10 poses, mostly done lying down, eyes are often closed, with bolsters and/or blankets used 
for comfort and warmth,  Because eyes are often closed, and movement is limited, the instructor typically provides 
more instructions on deep breathing techniques and guided imagery.   
The details of the RY intervention will be developed using the expertise of our team of experienced yoga 
instructors and the feedback from the Phase 1 Qualitative Interviews.  Our yoga experts have training and experience 
delivering RY sessions. The team will read and discuss The iRest Program for Healing PTSD,101 a recent book that 
outlines the iRest approach to treating PTSD. The team will also review and discuss a RY practice manual developed 
for metabolic syndrome by our colleagues at UCSD and UCSF. The 42-page manual explains 5 different poses with 
an additional 8 modifications to those poses, and provides pictures and helpful tips. Based on these materials, our 
yoga experts will develop our RY intervention and create an intervention manual and a home practice manual. The 
intervention will occur 2x weekly for 12 weeks – each class will be 60 minutes to match that timeframe of the active 
yoga intervention.  
 
 
Treatment Fidelity.  
Instructor fidelity to the yoga intervention manual will be evaluated using video recordings of yoga intervention sessions. 
All yoga sessions will be recorded with a digital camcorder and tripod placed in the back of the yoga room. Instructors 
and participants will be aware of and consent to the recordings. We do not plan to analyze all recorded sessions, but 
recording all sessions will standardize the presence of the camera across all sessions and result in more rapid habituation. 
Of the 24 sessions videotaped at each site, we will randomly select a session from weeks 1-4, weeks 5-8, and weeks 9-12 
for review by a yoga instructor from Yoga Oceanside. They will review the sessions using a manual checklist for 
instructor adherence to the yoga manuals, which will consist of a Yes/No, blank, and 0-10 rating scale for each procedure 
or instruction. 
   
Data management. Questionnaires will be formatted by the project coordinator under the supervision of Dr. Groessl (PI). 
Formatting will be designed to reduce recording errors and facilitate computer scanning and verification. Forms will be 
de-identified to protect confidentiality, and data will be scanned and verified by the data manager (and project 
coordinator). The project coordinator will monitor the quality of the questionnaire data as soon as they are collected to 
achieve prompt resolution of errors and omissions. Data will be stored on a password protected secure network server at 
UCSD. Access privileges are limited to essential staff.  
 
Statistical Management and Analysis: Qualitative data will be managed and analyzed by Co-I Hurst. Results will be 
presented to the research team and additional sub-analyses will be conducted as needed before the intervention is 
modified. Health outcome data and mediational variables will be collected directly before and after the 12-week yoga 
program using physiological assessments and questionnaires. We will assess the effect size of the difference in change in 
health outcomes (pain interference, pain severity, and physical functioning) from pre- to post-intervention between 

 
 
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intervention groups using a linear random effects model. We will assess clustering by site with a likelihood ratio test. The 
point estimate of difference in change score between two groups and the 95% confidence interval for the estimated 
difference will be provided. We will also perform multivariate analysis and an adjusted effects size (with 95% CI) by 
including baseline characteristics that are significantly imbalanced between two groups as covariates in the random 
effects model.  Analyses will be conducted by the biostatistician (Dr. Liu).  The effect size estimates (and CI width) will 
help inform power calculations for the subsequent R01 submission. R software packages will be used for all statistical 
analyses. 
 
 
 
 
10. 
HUMAN SUBJECTS 
The subject population will consist of 80 adults, 70-75 active-duty military personnel with chronic low back pain (CLBP) 
or chronic neck pain (CNP) and 5-10 yoga instructors or healthcare providers who have provided yoga or care for active-
duty military personnel with CLBP or CNP. 
 
 
In Phase 1:  
30 qualitative interviews will be conducted. 20-25 active-duty military personnel and 5-10 yoga instructors or healthcare 
providers who have provided yoga or care for active-duty military personnel with CLBP or CNP will participate in the 
interviews. Inclusion criteria for the qualitative interviews includes being active-duty personnel in the U.S. military, and 
having a self-reported history of CLBP or CNP. Inclusion criteria for instructors/providers includes having self-reported 
experience teaching yoga or providing other pain treatments for active-duty military personnel with CLBP or CNP.  
 
In Phase 2:  50 active-duty military personnel with CLBP will be recruited and randomized to either active hatha yoga or 
to restorative yoga. Inclusion criteria are as follows: 
Inclusion: 
• 
Diagnosis of CLBP or CNP > 6 months 
• 
Willing to attend a yoga program for 12 weeks  
• 
Willing to complete 3 assessments 
• 
English literacy 
• 
Have had no changes in pain treatments in the past month 
• 
Willing to not change pain treatments during study unless medically necessary 
• 
Have not practiced yoga more than 2x in the last 12 months 
Exclusion: 
• 
Back or neck surgery within the last year 
• 
Back or neck pain due to specific systemic problem (e.g., lupus, scoliosis) 
• 
Severe vertebral disk problems,  
• 
Persistent sciatica or nerve compression > 3 months 
• 
Coexisting chronic pain problem (e.g., migraine headaches, fibromyalgia) 
• 
Serious or unstable psychiatric illness (e.g., psychosis, mania, episode, or substance dependence)  
• 
Major coexisting medical illness (e.g., cancer, COPD, morbid obesity) 
• 
Positive Romberg test (with or without sensory neuropathy) 
 
No other exclusion criteria will be employed. No special classes of subjects or other vulnerable populations will be 
recruited. We will make efforts to recruit at least representative proportions of women and racial and ethnic minorities. 
More detail is provided on the inclusion of women and minorities document in this application. 
 
11. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
Phase 1: Qualitative Interviews 
We will recruit a total of 30 stakeholders to participate in qualitative interviews. Of the 30 participants, 20-25 will be 
military personnel with CLBP and/or CNP and 5-10 will be clinicians who provide yoga or other clinical care to military 

 
 
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personnel with CLBP or CNP. Of the 20-25 participants with CLBP/CNP, we will enroll at least 8-10 participants who 
have not done yoga before to explore reasons or perceived barriers to yoga participation. Recruitment will primarily occur 
through the posting of flyers and word of mouth with our military and community partners. A full Military IRB approval 
is not required to post flyers at the military facility or to conduct qualitative interviews at community locations off-base. 
Once we obtain permissions from the appropriate Public Affairs Office for the base, we will post flyers on military bases. 
For the 5-10 instructors/healthcare providers, we will recruit using connections with our military/community partners, and 
if needed, our contacts with additional healthcare providers in the San Diego area including UCSD and VA San Diego. 
Participants will receive a $30 gift card for participating in a qualitative interview. 
 
 
 
Phase 2:  Yoga Classes  
(Please note:  before we begin Phase 2 we will also need to obtain IRB approval from NMCSD for activities that 
will take place at that site.  Once we obtain IRB approval from NMCSD, we will provide a copy to UCSD’s IRB 
prior to commencing any activities at that site.)   
Recruitment for Phase 2 will occur primarily through our military and community partners. However, we will use 
qualitative interview data to steer and refine our recruitment methods. The NMCSD is our military research partner and 
they provide care to over 100,000 active-duty military personnel each year. With an estimated 25% of the general 
population having chronic low back pain at any one time, and higher rates among military personnel, the pool of potential 
participants can safely be placed at over 20,000. Some will not meet study criteria for various reasons, but a large number 
will be eligible. Once military IRB approval is obtained, Dr. Fowler and staff can post the study flyer and information on 
a research opportunities website, request inclusion in widely distributed e-mails, notify primary care physicians, pain 
management staff, and other healthcare providers, and they can post flyers on medical center posting boards. Recruitment 
will also occur at Yoga Oceanside and through the Connected Warriors organization. Flyers will be posted within their 
facilities and announcements will be at the end of classes. They will both use social media (e.g. Facebook) to 
communicate these research opportunities to their communities (CW has 1600+ followers, and Yoga Oceanside has 
500+). If needed, the study will also advertise the study in local military newspapers including three online publications 
from Echo Media (Miramar Flight Jacket, Navy Compass, Camp Pendleton Scout) which have a weekly readership of 
88,000 and/or the Military Press publication (bi-weekly readership of over 100,000 active-duty military). 
 
12. 
INFORMED CONSENT 
Prior to participation in this project, participants will be thoroughly apprised of study considerations and will 
undergo an informed consent process. We will emphasize the key elements of the informed consent procedure: 
1) the research status of the study; 2) the prospect of physical or psychological risk and the provisions for it; 3) 
the lack of guarantee of benefit from participation; 4) the confidentiality of the participant's responses; 5) the 
voluntary nature of the study; and 6) the freedom to withdraw from the study or to refuse to answer specific 
questions at any time. Only individuals who consent to all study conditions will be enrolled. The participant 
will complete the informed consent process with the RA and will be given a copy of the signed document for 
his or her records.  
Trained research staff, who are experienced in recruitment for clinical trials and medical research, will facilitate 
the consenting for the qualitative interviews in Phase 1 and before the screening appointments in Phase 2.  Prior 
to beginning the study, the PI will ensure compliance with IRB requirements and protections by obtaining 
approval from University of California San Diego and the Naval Medical Center San Diego (for procedures 
done at that facility) and will insure all protections are followed.  
 
13. 
ALTERNATIVES TO STUDY PARTICIPATION 
The alternative to participation is not to participate. 
 
14. 
POTENTIAL RISKS 

 
 
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In the focus groups of Phase 1, research staff will explore the thoughts, experiences, and opinions of participants with 
respect to CLBP and yoga as a treatment for CLBP. They will also discuss perceptions of different aspects of a yoga 
intervention regarding their desirability, acceptability, and efficacy, none of which are anticipated to produce negative 
emotional reactions. However, participants will be given contact information for sources of help that they can contact if 
they are feeling distressed or desire help. 
 
Phase 2 will involve participants attending two different yoga programs. Minor physical risks are always possible in yoga 
classes, although the frequency of injury has been low for CLBP and CNP patients in major studies. A small possibility 
also exists for injury during the physiological assessments, where someone may be asked to stand on one foot, hold a 
plank position, bend forward, or squeeze a dynamometer.   In the event that someone is injured, the usual procedure 
followed at that particular facility will be followed. For example, active-duty military doing yoga at NMCSD will receive 
care at NMCSD. Participants doing yoga through Yoga Oceanside and the Connected Warriors program can get free care 
through UCSD. These organizations require instructors to be fully insured through the Yoga Alliance.   
 
Summary of safety information. Like other exercise activity, the risks of injury from improperly performing yoga 
postures vary depending on how, where, and with whom the yoga is practiced. The initial practice of yoga under the 
direction of experienced yoga instructors, following a program that has modifications for people with limitations, and 
consulting a physician before starting a yoga program are all recommendations24 that will be followed in the proposed 
study. Data from RCTs of yoga for adults with CLBP reveal that the 3 serious adverse events among 309 persons doing 
yoga in these studies were all related to herniated discs, and at least one of these was found to be unrelated to yoga 
practice.22,23,102,103 Disc problems are common in this population in the absence of yoga practice, and thus yoga does 
not appear to greatly increase that risk. Among the 63 people with CNP who did yoga in two RCTs, no serious adverse 
events occurred. So despite popular media reports of the dangers of yoga, no specific data or evidence of risk has been 
presented. The poses specifically cited as being dangerous, usually head and shoulder stands and their variations probably 
do present some risk for novices, and are not being used in the proposed study. By screening out patients at greater risk, 
placing emphasis on slowly building a safe yoga practice, and hands on instruction from experienced instructors will be 
used to ensure that the yoga is practiced in the safest possible manner throughout the study. 
 
In both Phase 1 and Phase 2, there is a risk of loss of confidentiality.  No physical, legal, or social risks are anticipated as 
a result of participating in other phases or aspects of this study. The assessment questionnaires ask participants to consider 
and/or report health symptoms and functioning, and medication use which are not anticipated to cause negative emotional 
reactions. However, participants in each phase of the study will be given contact information for sources of help that they 
can contact if they are feeling distressed or desire help. 
 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
All participants will be provided the Principal Investigator’s and Project Coordinator’s phone numbers, whom they can 
contact if they have questions or need assistance. All participants are made aware that they can discontinue participation 
at any time. The PI and program staff will assist the participant in obtaining a referral to a mental health professional if 
requested or indicated. Risks to subject confidentiality will be addressed by identification of subject information only 
through code numbers: Data stored in the computer will only be identified with a code number. A separate file with 
corresponding identifying information and contact information will be kept in a separate computer file that will be 
password protected. Only the appropriate research staff will have access to specific subject information. 
 
Adverse events: The investigators will track adverse events and report these on a daily basis to the Principal Investigator. 
Serious adverse events will be immediately reported by phone and in writing to the IMC and to the Institutional Review 
Board of the University of California San Diego, or relevant military IRB. Serious adverse events include death, 
substantial risk of dying, hospitalizations, disability, or emergency medical intervention attributable to participation in the 
study (http://www.fda.gov/medWatch/report/DESK/advevnt.htm).  We will conduct weekly research team meetings. 
Once a month at these research team meetings, all adverse events occurring over the previous month and over the course 
of the study will be reviewed.  Serious adverse events will be reviewed immediately and reviewed again at the monthly 
meeting. All reported adverse events will be reported to the IRBs at that site as well as the University of California San 
Diego IRB, which will be the primary IRB of the study.  
 

 
 
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Additional precautions: Any adverse events or protocol deviations by the PI or research assistant will be reported within 
72 hours of its coming to the PI’s attention. We will take regular precautions to protect human research participants 
during the course of the study. The investigators will be in regular contact on a daily or weekly basis by e-mail or phone 
so urgent problems will be addressed in a timely manner. The PI or other key personnel will inform the PI or research 
team about any vacation or absences so that coverage of study duties can be arranged. 
 
If this study is funded and carried out, we will assemble an Independent Monitoring Committee (IMC) to monitor the 
progress and safety of the study as it proceeds. The PI will recruit 3 content or scientific experts who are not involved 
with this grant to serve on the IMC.  One person will be a clinical psychologist or psychiatrist who specializes in 
diagnosing and treating psychological disorders among active-duty military; another will be an orthopedist or orthopedic 
surgeon; the third will be a statistician. The IMC will review the study protocol prior to activation and develop an IMC 
plan. The IMC will evaluate the data on an ongoing basis and assure participant safety and study integrity. The IMC will 
be responsible for monitoring data and for making recommendations based on the data regarding appropriate protocol and 
any operational changes. The committee will meet every 6 months to review progress, preliminary data, and any adverse 
events.  They will meet with the PI to make recommendations regarding the progress of the study and will be able to 
report to the Institutional Review Board of the University of California San Diego. Following review, the IMC will write 
a report outlining recommendations. These recommendations will be forwarded to the Principal Investigator (Dr. Groessl) 
at the University of California San Diego and the IRB Chair at the University of California San Diego. 
 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
All signed consent forms, HIPAA forms, and the video and audio recordings for Phases 1 and 2 will be transported 
directly to Dr. Groessl’s office at the UCSD Health Services Research Center at 5440 Morehouse Dr. #3500 San Diego, 
CA, 92121 where they will be stored in a locked file cabinet within the locked office. All questionnaires and other data 
recording forms will be pre-labeled with the participants’ ID # and stored at the UCSD Health Services Research Center. 
The key connecting participant identifiers with the ID number is also kept in a locked cabinet and on password protected 
computers that reside within a firewall and data security system. 
 
For all phases of the project, a secure, password protected encrypted database will be constructed for the names and 
contact information of participants that contact the Project Coordinator during recruitment. This information will be 
stored on a secure network server and password protected. Only the Project Coordinator and one trained research staff 
will have access to this database. Each participant will be assigned a study ID # which will be used for all assessment 
materials. All assessment information (questionnaires and measurements) will only labeled with the study ID. No names 
or other identifiers will appear on assessment materials.  A separate database will be constructed containing the de-
identified data.  No identifying information will be linked with respondent answers. 
 
Additionally, for Phases I and II, participants are informed that audio-/video-recordings may be stopped at any time and 
that portions and/or the entire tape may be erased at the participant’s request.  Also, notes and audio-recordings will be 
anonymously transcribed. Following transcription, the audio-recordings will be destroyed.  
 
17. POTENTIAL BENEFITS 
The primary purpose of the study is to examine feasibility of yoga research and refinement of a yoga intervention for 
active-duty military personnel.  Thus, no direct benefit to participants is anticipated. Yoga has been shown to improve 
health outcomes in other populations with CLBP/CNP, and may help some individuals, but our study is not powered to 
make scientific conclusions regarding efficacy.  Results of the study will provide important information that will prepare 
study investigators to conduct a full-scale randomized controlled trial of yoga for military personnel with CLBP/CNP. 
 
The results of this study will provide essential information for medical and mental health professionals who treat veteran 
and active-duty US military regarding the dimensions of yoga perceived as most helpful and well-received for different 
conditions, and will guide future research asking specific questions regarding efficacy and effectiveness of specific 
interventions.   
 
18. RISK/BENEFIT RATIO 
The investigators believe that it is unlikely that confidentiality concerning personal medical information will be breached 

 
 
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given the security plan. It is also unlikely that patients will suffer serious emotional discomfort because they are fully 
informed about what will happen during the study and have sufficient time to prepare and decline participation if 
necessary. They also can stop participating at any time without penalty. 
Rates of physical injury and adverse events from yoga in previous studies with similar populations are low, and appear no 
higher than natural rates of injury in this population.  
 
Yoga has been shown to improve health outcomes in other populations with CLBP/CNP, and may help some 
individuals.22-23 
Therefore, the investigators believe that the potential benefits to participants and the potential of obtaining new scientific 
information and designing new interventions for people with chronic low back pain outweigh the potential risks. 
 
19. EXPENSE TO PARTICIPANT 
The only expense to the subjects would be transportation costs to travel to the yoga classes. Time is required for them to 
complete the questionnaires. Some active duty military personnel may be unable to receive compensation for completing 
assessments, and would have to donate their time. 
 
20. COMPENSATION FOR PARTICIPATION 
Phase 1:  Qualitative Interviews – 30 participants will receive a $30 gift card to Trader Joes for participating in 
a 60 minute interview. 
 
Phase 2:  Yoga Interventions – 50 participants will receive 24 free 1-hour yoga classes (12 weeks of 2 classes 
per week), plus a $30 gift card to Trader Joes for each assessment attended ($30 x 2 assessments = total of $60 
in gift cards). 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
Principal Investigator:  Erik Groessl, Ph.D. 
Dr. Erik Groessl has a Ph.D. in Clinical Psychology and has conducted research at UCSD and the VA for over 12 years. He 
has conducted and published yoga research at the VA San Diego and has extensive experience with health measurement.  
Erik Grossel, Ph.D. is a psychologist and a faculty member in the Department of Family and Preventive Medicine, UCSD.  
Dr. Groessl will assist in overall study administration, oversee data collection, and perform analysis and report writing. 
 
Co-Investigator: Crystal Park, Ph.D. 
Dr. Crystal Park is a Psychologist who has done extensive yoga research. Dr. Park will assist in all phases of the study 
design, implementation, analysis and interpretation. In year one of the project, Dr. Park will work closely with PI Groessl 
and staff to assist in successful launch. She will travel to San Diego to meet with the study team. In years two and three, 
Co-I Park will assist in interpretation and preparation of new grant proposals. Throughout the project, Dr. Park will have 
regular conference calls with the study team and be available for discussing issues and problems as they arise. 
 
Project Coordinator – Danielle Casteel has a M.A. in Psychology (with an emphasis in Physical and Mental Health) from 
San Diego State University - May, 2015.  She has been working in human subjects research for 4 years and has experience 
providing informed consent, conducting participant assessments, data entry, data cleaning, and data analysis. 
 
Site Principal Investigator: Dr. Ian Fowler, MD  
Dr. Fowler is the Director of the Pain Management Center at Naval Medical Center, San Diego 
(NMCSD). He will serve as the site Principal Investigator at NMCSD. He will work closely with the Wellness program at 
NMCSD, to screen and refer patients to the study.  He will assist with obtaining military IRB approval and conducting all 
aspects of research and at NMCSD. 
 
Dr. Douglas Chang, MD, PhD, Co- Investigator is Chief of Physical Medicine and Rehabilitation and Assistant 
Professor in the Department of Orthopaedic Surgery at the University of California San Diego. He also has a PhD in 
bioengineering from UCSD. Dr. Chang is a researcher and clinician who specializes in orthopedic surgery of the spine, 
and treatment of chronic low back pain. Dr. Chang will advise the research team concerning diagnostic/screening and 

 
 
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inclusion/exclusion criteria issues, and will assist with screening examinations as needed. He will meet with the research 
team on a regular basis and will contribute to the dissemination of results, and subsequent preparation for a full-scale R01 
study. 
 
Qualitative Expert:  Samantha Hurst, PdD, MA received her Ph.D. in Biological Anthropology from the University of 
Tennessee, Knoxville and did her Post-Doctoral Fellowship training as a Medical Anthropologist in the Alcohol Research 
Center at The Scripps Research Institute in La Jolla. Dr. Hurst has extensive experience conducting qualitative interviews 
and analyzing qualitative data.  
 
 
Consultant:  Laura Schmalzl, Ph.D.  
Laura Schmalzl received her Ph.D. in Cognitive Science from Macquarie University in Sydney, Australia.  Additionally, 
her contribution to the current project as a co-investigator is the combination of clinical, scientific, and Yoga related 
trainings. Laura trained and practiced as a Clinical Neuropsychologist, followed by a PhD and Post-doctoral work in 
Cognitive Neuroscience. In addition, she is a Yoga Alliance Registered Yoga Teacher (500-hour level). 
 
Yoga Instructor / Yoga Instructor Trainer: Camilla Sinclair 
Camilla Sinclair, RYT 500 is a certified yoga instructor who has been practicing yoga for over 16 years and has over 8 
years of teaching experience. She taught the VA Yoga for CLBP for over 5 years and helped design the intervention. Ms. 
Sinclair will assist Dr. Schmalzl and Bettey Michalewicz with adapting the intervention in Phase 2 of the study based on 
results from Phase I. She will also assist with training instructors for the active yoga program.  
 
 
 
 
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23. FUNDING SUPPORT FOR THIS STUDY 
Financial support for the study is pending NCCIH Council Review. This submission is part of the standard JIT 
process. 
 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
N/A 
 
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
N/A 
 
26. IMPACT ON STAFF 
N/A 
 
27. CONFLICT OF INTEREST 
None of the investigators have conflicts of interest with any aspect of the study. 
 
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
N/A 
 
29. OTHER APPROVALS/REGULATED MATERIALS 

 
 
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N/A 
 
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
N/A