Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
This study is currently recruiting participants.
Verified December 2012 by Boston Medical Center
Sponsor:
Boston Medical Center
Information provided by (Responsible Party):
Robert B Saper, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01343927
First received: April 20, 2011
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
A 12-week randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Back Pain Lower Back Chronic |
Behavioral: Yoga Class Behavioral: Physical therapy Behavioral: Education |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations |
Resource links provided by NLM:
Further study details as provided by Boston Medical Center:
Primary Outcome Measures:
- Change from Baseline in Average Pain intensity in previous week [ Time Frame: 12 wks ] [ Designated as safety issue: No ]Intensity of pain in previous week as measured on a 10 point numerical scale (0-10).
- Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability [ Time Frame: 12 wks ] [ Designated as safety issue: No ]Utilize modified 23 point scale standardized Roland Morris questionnaire to asses back pain specific disability.
Secondary Outcome Measures:
- Change from Baseline in Pain Medication use in the previous week [ Time Frame: 12wks ] [ Designated as safety issue: No ]Specific self reported pain medication use in previous week.
- Treatment adherence (class attendance) [ Time Frame: 12 wks ] [ Designated as safety issue: No ]Assess treatment adherence according to attendance during 12 week intervention period.
- Number of participants with Adverse Events as a measure of safety and treatment adherence [ Time Frame: 12wks ] [ Designated as safety issue: Yes ]Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.
- Change from Baseline for Health related Quality of Life using SF-36 survey [ Time Frame: 12wks ] [ Designated as safety issue: No ]Use standardized Quality of life SF-36 questionnaire.
| Estimated Enrollment: | 320 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Yoga Class
12 week yoga intervention plus 40 weeks of either drop-in classes or home practice.
|
Behavioral: Yoga Class
Standardized 12 week Hatha yoga intervention developed specifically for chronic low back pain in adult populations; classes meet once a week at community health centers.
|
|
Active Comparator: Physical Therapy
15 sessions over 12 week intervention period plus 40 week maintenance of either 5 booster sessions or home practice.
|
Behavioral: Physical therapy
12 weeks of individual physical therapy. Weeks 1-5, 2 sessions per week. Weeks 6-8, one session per week. Weeks 9-12, one session every other week. Total of 15 sessions.
|
|
Active Comparator: Education
Education using "The Back Pain Helpbook" which gives exercises and tips for self-care pain management.
|
Behavioral: Education
Education intervention receives "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care. Also, continue with usual care.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Current non-specific low back pain persisting for at least 12 weeks
- 18-64 years old
- Mean low back pain intensity for the previous week of 4 or greater on a 0 to 10 numerical rating scale (0=no pain to 10=worst possible pain)
- English fluency sufficient to follow treatment instructions and answer survey questions.
- Willingness to list comprehensive contact information for at least one (preferably two) friend, family member, or work colleague who will always know how to contact the participant.
Exclusion Criteria:
- New CLBP treatments started within the previous month or anticipated to begin in the next 3 months
- Known pregnancy
- Inability to understand English at a level necessary to understand treatment instructions and survey questions
- Previous back surgery or back fracture
- Specific CLBP pathologies (including spinal canal stenosis, severe scoliosis, spondylolisthesis, ankylosing spondylitis, large herniated disk)
- Severe or progressive neurological deficits
- Sciatica pain equal to or greater than back pain
- Active or recent cervical radiculopathy
- Active or planned worker's compensation, disability, or personal injury claims
- Lack of consent
- Significant participation in yoga or physical therapy in the last six months
- Has read The Back Pain Helpbook or the Back Book in the previous six months
- The principal investigator judges the participant to be unable to participate in the study due to serious medical and/or psychiatric comorbidities
- Has previously participated in the Yoga Dosing Study or the Physical Therapy Pilot
- Plans to move out of the Boston area in the next year
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343927
Contacts
| Contact: Julia Keosaian, MPH | 617-414-6228 | julia.keosaian@bmc.org |
| Contact: Ama Boah, MS | 617-414-6218 | ama.boah@bmc.org |
Locations
| United States, Massachusetts | |
| Boston Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Dorchester House MultiService Center | Recruiting |
| Dorchester, Massachusetts, United States, 02112 | |
| Codman Square Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02124 | |
| Upham's Corner Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02125 | |
| Greater Roslindale Medical and Dental Center | Not yet recruiting |
| Roslindale, Massachusetts, United States, 02131 | |
| South Boston Community Health Center | Not yet recruiting |
| South Boston, Massachusetts, United States, 02127 | |
Sponsors and Collaborators
Boston Medical Center
Investigators
| Principal Investigator: | Robert B Saper, MD, MPH | Boston University School of Medicine/ Boston Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert B Saper, Robert B. Saper, MD MPH, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01343927 History of Changes |
| Other Study ID Numbers: | 1R01AT005956-02A1 |
| Study First Received: | April 20, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
Chronic low back pain Community health center Yoga |
Physical therapy Minority populations Health education |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013