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Yoga vs. Education for Veterans With Chronic Low Back Pain

Primary Purpose

Recurrent Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Yoga
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Low Back Pain focused on measuring low back pain, yoga, education, Veterans, cost-effectiveness, military, back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bedford VA Edith Nourse Rogers Memorial VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Education

Yoga

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2014
Last Updated
July 18, 2016
Sponsor
Boston Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02224183
Brief Title
Yoga vs. Education for Veterans With Chronic Low Back Pain
Official Title
Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Low Back Pain
Keywords
low back pain, yoga, education, Veterans, cost-effectiveness, military, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Yoga
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Education
Intervention Description
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
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in low back pain
Description
Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change from baseline in back-related function
Description
Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in pain medication use
Description
Pain medication use in the previous 7 days will be measured
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change from baseline in health-related quality of life
Description
Measured using the VR-12
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Self-rated global improvement
Time Frame
6 weeks, 12 weeks, 24 weeks
Title
Patient satisfaction
Description
Measured using a single question that asks patients' overall satisfaction with their treatment
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change in post-traumatic stress symptoms
Description
Measured using PTSD Checklist - Civilian version (PCL-C)
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in post-concussive symptoms
Description
Measured using the Neurobehavioral Symptom Inventory (NSI)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in sleep quality
Description
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in depressive symptoms
Description
Measured using 9-item Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in anxiety symptoms (GAD-7)
Description
Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in coping skills
Description
Measured using the Coping Strategies Questionnaire (CSQ)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline in self-efficacy
Description
Measured using the Patient Self-Efficacy Questionnaire (PSEQ)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Marital/family functioning
Description
Measured using the Dyadic Adjustment Scale (DAS)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change in work status
Description
Measured using the Work Productivity and Activity Impairment questionnaire
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Cost-effectiveness
Description
Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions
Time Frame
6 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Saper, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bedford VA Edith Nourse Rogers Memorial VA Hospital
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27129472
Citation
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.
Results Reference
derived

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Yoga vs. Education for Veterans With Chronic Low Back Pain

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