NCT02224183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

August 20, 2014

Last Update Submit

July 18, 2016

Conditions

Recurrent Low Back Pain

Keywords

low back painyogaeducationVeteranscost-effectivenessmilitaryback pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Change from baseline in pain medication use

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change from baseline in health-related quality of life

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Self-rated global improvement

    6 weeks, 12 weeks, 24 weeks

  • Patient satisfaction

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change in post-traumatic stress symptoms

    Baseline, 6 weeks, 12 weeks, 24 weeks

Other Outcomes (9)

  • Change from baseline in post-concussive symptoms

    Baseline, 12 weeks, 24 weeks

  • Change from baseline in sleep quality

    Baseline, 12 weeks, 24 weeks

  • Change from baseline in depressive symptoms

    Baseline, 12 weeks, 24 weeks

  • +6 more other outcomes

Study Arms (2)

Education

ACTIVE COMPARATOR

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

Yoga

ACTIVE COMPARATOR

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

Interventions

EducationBEHAVIORAL

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.

Education
YogaBEHAVIORAL

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.

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bedford VA Edith Nourse Rogers Memorial VA Hospital

Bedford, Massachusetts, 01730, United States

Location

Related Publications (2)

  • 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.

    PMID: 36650329DERIVED

  • 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.

    PMID: 27129472DERIVED

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Educational StatusYoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Robert B Saper, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 25, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

US(1)