Yoga for Chronic Low Back Pain in Veterans

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT02224183
First received: August 20, 2014
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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 and final aim is to evaluate the cost-effectiveness of yoga for cLBP at 12 weeks and 24 weeks. 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 military population.


Condition Intervention
Chronic Low Back Pain
Stress Disorders, Post-Traumatic
Behavioral: Education
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Yoga for Chronic Low Back Pain in Veterans

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Change from baseline in low back pain [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Pain medication use in the previous 7 days will be measured

  • Change from baseline in health-related quality of life [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the SF-12

  • Self-rated global improvement [ Time Frame: 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using a single question that asks patients' overall satisfaction with their treatment

  • Change in post-traumatic stress symptoms [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using PTSD Checklist - Military version (PCL-M)

  • Change from baseline in depressive symptoms [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using 9-item Patient Health Questionnaire (PHQ-9)

  • Change from baseline in sleep quality [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI)


Other Outcome Measures:
  • Change from baseline in post-concussive symptoms [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Neurobehavioral Symptom Inventory (NSI)

  • Change from baseline in anxiety symptoms (GAD-7) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire

  • Change from baseline in coping skills [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Coping Strategies Questionnaire (CSQ)

  • Change from baseline in self-efficacy [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Patient Self-Efficacy Questionnaire (PSEQ)

  • Change from baseline in fear-avoidance beliefs [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Fear Avoidance Beliefs Questionnaire (FABQ)

  • Marital/family functioning [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Dyadic Adjustment Scale (DAS)

  • Change in work status [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Work Productivity and Activity Impairment questionnaire

  • Cost-effectiveness [ Time Frame: 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions


Estimated Enrollment: 120
Study Start Date: December 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Veteran of any branch of military service
  • Current low-back pain persisting ≥12 weeks with 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 cLBP treatments started within the previous month or anticipated to begin in the next 6 months
  • Known pregnancy
  • Known inflammatory or systemic causes of cLBP
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02224183

Locations
United States, Massachusetts
Bedford VA Edith Nourse Rogers Memorial VA Hospital Not yet recruiting
Bedford, Massachusetts, United States, 01730
Contact: A Rani Elwy, PhD    (781) 687-2861    rani.elwy@va.gov   
Principal Investigator: A Rani Elwy, PhD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Robert B Saper, MD, MPH Boston Medical Center
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02224183     History of Changes
Other Study ID Numbers: H-32948, R01AT005956-04S1
Study First Received: August 20, 2014
Last Updated: August 21, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Boston Medical Center:
chronic low back pain
yoga
education
Veterans
cost-effectiveness

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014