Clinical Trials Directory

Trials / Completed

CompletedNCT03504085

Overcoming Pain Through Yoga in the Military

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
University of California, San Diego · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERYoga: Active HathaClassical 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
OTHERYoga: RestorativeRestorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.

Timeline

Start date
2018-05-01
Primary completion
2020-05-31
Completion
2020-05-31
First posted
2018-04-20
Last updated
2023-02-17
Results posted
2023-02-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03504085. Inclusion in this directory is not an endorsement.