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Recurrent Low Back PainNCT02224183

Yoga vs. Education for Veterans With Chronic Low Back Pain

A study testing Education and Yoga in people with Recurrent Low Back Pain, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Low Back Pain
What is being tested?
Education and Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Mar 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bedford VA Edith Nourse Rogers Memorial VA Hospital

    Bedford, Massachusetts, 01730

Other trials in United States

About this study

Official title: 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.

Being tested
Education, Yoga
Keywords
low back pain, yoga, education, Veterans, cost-effectiveness, military, back pain
Medical subject headings
Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationBehavioural

    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.

  • YogaBehavioural

    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.

Study groups in NCT02224183
Study groupRoleWhat they receive
EducationActive comparatorIndividuals 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.
Receives: Behavioral: Education
YogaActive comparatorWeekly 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.
Receives: Behavioral: Yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  2. Change from baseline in back-related function

    Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

Secondary outcomes (5)

  1. Change from baseline in pain medication use

    Pain medication use in the previous 7 days will be measured

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  2. Change from baseline in health-related quality of life

    Measured using the VR-12

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  3. Self-rated global improvement

    Measured: 6 weeks, 12 weeks, 24 weeks

  4. Patient satisfaction

    Measured using a single question that asks patients' overall satisfaction with their treatment

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

  5. Change in post-traumatic stress symptoms

    Measured using PTSD Checklist - Civilian version (PCL-C)

    Measured: Baseline, 6 weeks, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224183
Sponsor's protocol ID
H-32948
Other IDs
3R01AT005956-05S1
Status last verified
Jul 2016
First submitted
20 Aug 2014
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36650329

  • 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.

    PubMed 27129472

Questions about this trial

What is this clinical trial studying?

A study testing Education and Yoga in people with Recurrent Low Back Pain, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in low back pain (time frame: Baseline, 6 weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224183, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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