Overcoming Pain Through Yoga in the Military

Study Overview
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Brief Summary
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Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with Chronic Low Back Pain (CLBP) and/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 prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military.

Detailed Description
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In preparation for a full-scale study via a subsequent R01 proposal, our study objective is 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 study will be conducted in two phases: Phase 1 (completed) involved 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. The specific aims are as follows: Aim 1: Evaluate 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: Refine and modify the existing Yoga for CLBP intervention to address CNP, and the needs of active-duty military personnel. Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP into a yoga RCT. Aim 5: Evaluate the adherence of this population to the two yoga interventions. Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT. Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBP/CNP in a full-scale randomized, controlled trial. To be successful and maximize the scientific knowledge obtained from an R01 study, it is crucial to first establish working relationships with military researchers, ensure that recruitment and randomized assignment are feasible, pilot test measurement strategies, and ensure that both interventions will be well-attended and have been optimally chosen.

Official Title
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Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel

Conditions
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Chronic Low Back Pain, Chronic Neck Pain

Intervention / Treatment
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* Other: Yoga: Active Hatha
* Other: Yoga: Restorative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hatha Yoga<br>This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. | Other: Yoga: Active Hatha<br>* 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<br>* Other names: Active;|
| Active Comparator: Restorative Yoga<br>This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. | Other: Yoga: Restorative<br>* Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.<br>* Other names: Non-Active;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference | Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire | Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities. Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported | 
| BPI Pain Severity | Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating greater pain severity. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported | 
| Neck Disability Index | Ten-item self-report measure to assess neck pain interference in daily life activities. Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain. | assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, CLBP, Chronic Neck Pain, CNP, Chronic Pain, Military, Active Duty, Yoga, Mindbody