Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Pain Interference
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Hatha Yoga
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.
Intervention: Yoga: Active Hatha (Other)
Restorative Yoga
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.
Intervention: Yoga: Restorative (Other)
Outcomes
Primary Outcomes
Pain Interference
Time Frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
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.
Secondary Outcomes
- Neck Disability Index(assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported)
- Roland-Morris Disability Questionnaire(assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported)
- BPI Pain Severity(assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported)
Investigators
Erik Groessl
Associate Professor
University of California, San Diego