Yoga vs. Education for Veterans With Chronic Low Back Pain

Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain

Chronic low back pain (cLBP) is the most common pain condition in the military, causing substantial physical and psychological suffering, reduction in force readiness, and high economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting it may be effective in reducing pain intensity, improving back-related function, and lowering pain medication use. Multiple differences exist between civilian and military populations with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha yoga classes, supplemented with home practice, compared to an education group. Additionally, the enormous mental health burden often shouldered by returning military personnel presents another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP and psychological comorbidities. These results will help determine whether yoga is an effective modality for addressing cLBP in a Veteran population.

Study Overview

• Status: Completed
• Conditions: Recurrent Low Back Pain
• Intervention / Treatment: Behavioral: Education; Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Bedford VA Edith Nourse Rogers Memorial VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Veteran of any branch of military service
• Current low-back pain present for at least half the days over the past 6 months mean pain intensity for the previous week ≥4 on 0-10 rating scale

Exclusion Criteria:

• Significant yoga practice in the previous 6 months
• Have read The Back Pain Helpbook in the previous 6 months
• New LBP treatments started within the previous month or anticipated to begin in the next 3 months
• Known pregnancy
• Known inflammatory or systemic causes of LBP
• Severe and/or progressive medical, neurological, or psychiatric comorbidities
• Inability to understand/speak English
• Plans to move out of the area in the next 6 months
• Lack of informed consent
• Unwillingness to be randomized

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education; Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.	Behavioral: Education; Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.
Active Comparator: Yoga; Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.	Behavioral: Yoga; Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in low back pain	Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale	Baseline, 6 weeks, 12 weeks, 24 weeks
Change from baseline in back-related function	Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).	Baseline, 6 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pain medication use	Pain medication use in the previous 7 days will be measured	Baseline, 6 weeks, 12 weeks, 24 weeks
Change from baseline in health-related quality of life	Measured using the VR-12	Baseline, 6 weeks, 12 weeks, 24 weeks
Self-rated global improvement		6 weeks, 12 weeks, 24 weeks
Patient satisfaction	Measured using a single question that asks patients' overall satisfaction with their treatment	Baseline, 6 weeks, 12 weeks, 24 weeks
Change in post-traumatic stress symptoms	Measured using PTSD Checklist - Civilian version (PCL-C)	Baseline, 6 weeks, 12 weeks, 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in post-concussive symptoms	Measured using the Neurobehavioral Symptom Inventory (NSI)	Baseline, 12 weeks, 24 weeks
Change from baseline in sleep quality	Measured using the Pittsburgh Sleep Quality Index (PSQI)	Baseline, 12 weeks, 24 weeks
Change from baseline in depressive symptoms	Measured using 9-item Patient Health Questionnaire (PHQ-9)	Baseline, 12 weeks, 24 weeks
Change from baseline in anxiety symptoms (GAD-7)	Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire	Baseline, 12 weeks, 24 weeks
Change from baseline in coping skills	Measured using the Coping Strategies Questionnaire (CSQ)	Baseline, 12 weeks, 24 weeks
Change from baseline in self-efficacy	Measured using the Patient Self-Efficacy Questionnaire (PSEQ)	Baseline, 12 weeks, 24 weeks
Marital/family functioning	Measured using the Dyadic Adjustment Scale (DAS)	Baseline, 12 weeks, 24 weeks
Change in work status	Measured using the Work Productivity and Activity Impairment questionnaire	Baseline, 12 weeks, 24 weeks
Cost-effectiveness	Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions	6 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Robert B Saper, MD, MPH, Boston Medical Center

Publications and helpful links

General Publications

• Saper RB, Lemaster CM, Elwy AR, Paris R, Herman PM, Plumb DN, Sherman KJ, Groessl EJ, Lynch S, Wang S, Weinberg J. Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):224. doi: 10.1186/s13063-016-1321-5.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: low back pain; back pain; Veterans; yoga; education; military; cost-effectiveness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: H-32948; 3R01AT005956-05S1 (U.S. NIH Grant/Contract)