Yoga vs. Education for Veterans With Chronic Low Back Pain

Recurrent Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224183
• Other study ID #: H-32948
• Secondary ID: 3R01AT005956-05S
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: July 18, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrent Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Bedford VA Edith Nourse Rogers Memorial VA Hospital	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in post-concussive symptoms	Measured using the Neurobehavioral Symptom Inventory (NSI)	Baseline, 12 weeks, 24 weeks	No
Other	Change from baseline in sleep quality	Measured using the Pittsburgh Sleep Quality Index (PSQI)	Baseline, 12 weeks, 24 weeks	No
Other	Change from baseline in depressive symptoms	Measured using 9-item Patient Health Questionnaire (PHQ-9)	Baseline, 12 weeks, 24 weeks	No
Other	Change from baseline in anxiety symptoms (GAD-7)	Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire	Baseline, 12 weeks, 24 weeks	No
Other	Change from baseline in coping skills	Measured using the Coping Strategies Questionnaire (CSQ)	Baseline, 12 weeks, 24 weeks	No
Other	Change from baseline in self-efficacy	Measured using the Patient Self-Efficacy Questionnaire (PSEQ)	Baseline, 12 weeks, 24 weeks	No
Other	Marital/family functioning	Measured using the Dyadic Adjustment Scale (DAS)	Baseline, 12 weeks, 24 weeks	No
Other	Change in work status	Measured using the Work Productivity and Activity Impairment questionnaire	Baseline, 12 weeks, 24 weeks	No
Other	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Change from baseline in health-related quality of life	Measured using the VR-12	Baseline, 6 weeks, 12 weeks, 24 weeks	No
Secondary	Self-rated global improvement		6 weeks, 12 weeks, 24 weeks	No
Secondary	Patient satisfaction	Measured using a single question that asks patients' overall satisfaction with their treatment	Baseline, 6 weeks, 12 weeks, 24 weeks	No
Secondary	Change in post-traumatic stress symptoms	Measured using PTSD Checklist - Civilian version (PCL-C)	Baseline, 6 weeks, 12 weeks, 24 weeks	No