Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01343927|
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Lower Back Chronic||Behavioral: Weekly yoga classes Behavioral: Individual physical therapy treatment Behavioral: Education||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Yoga
12 weeks of weekly yoga classes plus 40 weeks of either drop-in classes or home practice.
Behavioral: Weekly yoga classes
Manualized 12-week Hatha yoga intervention developed specifically for chronic low back pain in adult populations; classes meet once each week at community-based locations.
Active Comparator: Physical Therapy
15 individual physical therapy sessions over 12 weeks plus 40 weeks with either 5 booster sessions or home practice.
Behavioral: Individual physical therapy treatment
12 weeks of fifteen individual physical therapy sessions divided as follows: Week 1 intake appointment; weeks 2-4 two appointments per week; weeks 5-12 one appointment per week.
Active Comparator: Education
"The Back Pain Helpbook" which gives exercises and tips for self-care pain management.
Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.
- Change from Baseline in Average Pain intensity in previous week [ Time Frame: 12 wks ]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 ]Utilize modified 23-point scale standardized Roland Morris questionnaire to asses back pain specific disability.
- Change from baseline in Pain Medication use in the previous week [ Time Frame: 12wks ]Specific self-reported pain medication use in previous week.
- Satisfaction with assigned intervention at 12 weeks [ Time Frame: 12 wks ]Self-reported satisfaction with intervention using 5-point Likert scale from very dissatisfied to very satisfied
- Global improvement in back pain at 12 weeks [ Time Frame: 12wks ]Self-reported rating of global improvement since start of study using 7-point Likert scale from extremely worsened to extremely improved
- Change from Baseline for Health related Quality of Life using SF-36 survey [ Time Frame: 12wks ]Use standardized Quality of life SF-36 questionnaire.
- Work productivity [ Time Frame: 12wks ]Use standardized Work Productivity and Activity Impairment questionnaire to assess employment status and productivity
- Number of participants with Adverse Events as a measure of safety and treatment adherence [ Time Frame: 12wks ]Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.
- Treatment adherence (class/session attendance) [ Time Frame: 12wks ]Assess treatment adherence according to attendance during 12 week intervention period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343927
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|South End Community Health Center|
|Boston, Massachusetts, United States, 02118|
|Dimock Health Center|
|Boston, Massachusetts, United States, 02119|
|Dorchester House MultiService Center|
|Dorchester, Massachusetts, United States, 02112|
|Codman Square Health Center|
|Dorchester, Massachusetts, United States, 02124|
|Upham's Corner Health Center|
|Dorchester, Massachusetts, United States, 02125|
|Greater Roslindale Medical and Dental Center|
|Roslindale, Massachusetts, United States, 02131|
|South Boston Community Health Center|
|South Boston, Massachusetts, United States, 02127|
|Principal Investigator:||Robert B Saper, MD, MPH||Boston University School of Medicine/ Boston Medical Center|