Yoga vs. Education for Veterans With Chronic Low Back Pain

NCT ID: NCT02224183

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-07-31

Brief 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.

Conditions

Recurrent Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Yoga

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert B Saper

BMC Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert B Saper, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Bedford VA Edith Nourse Rogers Memorial VA Hospital

Bedford, Massachusetts, United States

Countries

United States

References

Roseen EJ, Pinheiro A, Lemaster CM, Plumb D, Wang S, Elwy AR, Streeter CC, Lynch S, Groessl E, Sherman KJ, Weinberg J, Saper RB. Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial. J Gen Intern Med. 2023 Jul;38(9):2113-2122. doi: 10.1007/s11606-023-08037-2. Epub 2023 Jan 17.

Reference Type: DERIVED

PMID: 36650329 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27129472 (View on PubMed)

Other Identifiers

3R01AT005956-05S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-32948

Identifier Type: -

Identifier Source: org_study_id