Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Erik Groessl

Description

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.

Official Title

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

Details

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.

Keywords

Chronic Low Back Pain Chronic Neck Pain CLBP CNP Chronic Pain Military Active Duty Yoga Mindbody Back Pain Low Back Pain Neck Pain Yoga: Active Hatha Yoga: Restorative Hatha Yoga Restorative Yoga

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCSD's Health Services Research Center accepting new patients
    San Diego California 92121 United States
  • Navy Medical Center San Diego accepting new patients
    San Diego California 92134 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03504085
Lead Scientist
Erik Groessl
Study Type
Interventional
Last Updated
May 18, 2018