Overcoming Pain Through Yoga in the Military (OPTYM)

University of California San Diego

Status: Completed

Conditions: Chronic Low Back Pain; Chronic Neck Pain

Treatments: Other: Yoga: Active Hatha; Other: Yoga: Restorative

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03504085

R34AT009073-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Hatha Yoga

Experimental group

Description:

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.

Treatment:

Other: Yoga: Active Hatha

Restorative Yoga

Active Comparator group

Description:

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.

Treatment:

Other: Yoga: Restorative