Overcoming Pain Through Yoga in the Military

Chronic Low Back Pain Clinical Trial

— OPTYM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504085
• Other study ID #: R34AT009073-01
• Secondary ID: R34AT009073-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Neck Pain
• Low Back Pain
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
United States	Navy Medical Center San Diego	San Diego	California
United States	UCSD's Health Services Research Center	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Center for Complementary and Integrative Health (NCCIH), United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical	12-Item self-report measure on individual's views about their physical health.; Scores are scaled to range from 0-100 with higher scores indicating better physical quality of life.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Other	HRQOL - SF12 - Mental Health	Mental Component Score for the SF12; Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Other	The Fatigue Severity Scale (FSS)	The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of > 4.0 constitutes severe fatigue.The measure has good psychometrics for pain disorders.; This is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score indicate greater fatigue severity.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Other	CES-D 10	Ten-item self-report measure on the frequency of mood symptoms. Scores greater than or equal to 10 indicate depression.; The 10 items are rated on a Likert scale from 0-3. Thus the total score ranges from 0-30 with higher scores indicating more depression.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Other	AUDIT-C	The AUDIT-C is a 3-item alcohol screen that reliably identifies patients who are hazardous drinkers or have alcohol use disorders. The AUDIT-C is a modified version of the 10 question AUDIT instrument.	baseline, 12-weeks, 6-months
Other	Dimensions of Anger Reactions (DAR)	Developed by Forbes et al., The Dimensions of Anger Reactions questionnaire consists of 7 items and has demonstrated strong internal reliability and concurrent validity with other existing measures of anger.	baseline, 12-weeks, 6-months
Other	The Brief Resilience Scale (BRS)	The Brief Resilience Scale (BRS) assesses and individuals ability to recover from stress or trauma. The measure consists of six items and has good reliability and validity.; The score is the mean of the 6 items, which are rated from 1 to 5. Scores range from 1-5.0 and higher scores indicate greater resilience.	baseline, 12-weeks, 6-months
Other	Self Efficacy for Chronic Low Back Pain Scale	A 6-item self-report measure of an individual's confidence in performing certain activities. Items range from 1 (not at all confident) to 10 (totally confident).; The score is the mean of the items and ranges from 1-10 with higher scores indicating greater self-efficacy.	baseline, 12-weeks, 6-months
Other	Physical Measures: Grip Strength	Grip strength will be measured with a hydraulic dynamometer. Two trials will be performed for each hand and the best performance will be taken for each side. The average of both hands is used for analysis.	baseline, 12-weeks, 6-months
Other	Physical Measures: Core Stabilization	Prone and supine bridge positions will assess core stabilization. Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each position is held in proper form.	baseline, 12-weeks, 6-months
Other	Physical Measures: Balance	Balance will be measures performance on a one-leg stand on each side. Assessors record length of time (2 minutes max) that each one-leg stand is held in proper form.	baseline, 12-weeks, 6-months
Other	PROMIS - Pain Intensity	PROMIS (Patient-Reported Outcomes Measurement Information System) measure - Pain Intensity; The PROMIS Pain Intensity instrument consists of three items with 5 response options ranging from 1 ("had no pain") to 5 ("very severe") addressing how much pain the person experiences now and in the past 7 days. The raw score is the sum of the three questions, with a minimum of 3 and a maximum score of 15, with higher scores indicating greater pain intensity.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Primary	Pain Interference	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.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Secondary	Roland-Morris Disability Questionnaire	Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities.; Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Secondary	BPI Pain Severity	Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 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 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 greater pain severity.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Secondary	Neck Disability Index	Ten-item self-report measure to assess neck pain interference in daily life activities.; Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain.	assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported