Overcoming Pain Through Yoga in the Military

NCT ID: NCT03504085

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-05-31

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.

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

Chronic Low Back Pain; Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga: Active Hatha

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Yoga: Restorative

Intervention Type: OTHER

Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.

Interventions

Yoga: Active Hatha

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

Intervention Type: OTHER

Yoga: Restorative

Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.

Intervention Type: OTHER

Other Intervention Names

Active; Non-Active

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Erik Groessl

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik Groessl, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Ian Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Navy Medical Center San Diego

Locations

UCSD's Health Services Research Center

San Diego, California, United States

Navy Medical Center San Diego

San Diego, California, United States

Countries

United States

References

Groessl EJ, Casteel D, McKinnon S, McCarthy A, Schmalzl L, Chang DG, Fowler IM, Park CL. Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial. Glob Adv Health Med. 2022 Jun 16;11:2164957X221094596. doi: 10.1177/2164957X221094596. eCollection 2022.

Reference Type: DERIVED

PMID: 35734420 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

R34AT009073-01

Identifier Type: NIH

Identifier Source: secondary_id

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R34AT009073-01

Identifier Type: NIH

Identifier Source: org_study_id

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