Clinical trial NCT03504085: Overcoming Pain Through Yoga in the Military
Official title: Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Chronic Neck Pain
Keywords: Chronic Low Back Pain
CLBP
Chronic Neck Pain
CNP
Chronic Pain
Military
Active Duty
Yoga
Mindbody
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, San Diego
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-04-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Pain Interference
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: BPI Pain Severity
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: Neck Disability Index
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Other outcomes:
measure: Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: HRQOL - SF12 - Mental Health
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: The Fatigue Severity Scale (FSS)
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: CES-D 10
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
measure: AUDIT-C
timeFrame: baseline, 12-weeks, 6-months
measure: Dimensions of Anger Reactions (DAR)
timeFrame: baseline, 12-weeks, 6-months
measure: The Brief Resilience Scale (BRS)
timeFrame: baseline, 12-weeks, 6-months
measure: Self Efficacy for Chronic Low Back Pain Scale
timeFrame: baseline, 12-weeks, 6-months
measure: Physical Measures: Grip Strength
timeFrame: baseline, 12-weeks, 6-months
measure: Physical Measures: Core Stabilization
timeFrame: baseline, 12-weeks, 6-months
measure: Physical Measures: Balance
timeFrame: baseline, 12-weeks, 6-months
measure: PROMIS - Pain Intensity
timeFrame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Locations:
city: San Diego
country: United States
facility: UCSD's Health Services Research Center
state: California
city: San Diego
country: United States
facility: Navy Medical Center San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Erik Groessl, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Navy Medical Center San Diego
name: Ian Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.