Back Pain Lower Back Chronic Clinical Trial
— Back to HealthOfficial title:
Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Verified date | February 2019 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 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.
Status | Completed |
Enrollment | 320 |
Est. completion date | December 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
United States | Dimock Health Center | Boston | Massachusetts |
United States | South End Community Health Center | Boston | Massachusetts |
United States | Codman Square Health Center | Dorchester | Massachusetts |
United States | Dorchester House MultiService Center | Dorchester | Massachusetts |
United States | Upham's Corner Health Center | Dorchester | Massachusetts |
United States | Greater Roslindale Medical and Dental Center | Roslindale | Massachusetts |
United States | South Boston Community Health Center | South Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26. — View Citation
Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with Adverse Events as a measure of safety and treatment adherence | Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence. | 12wks | |
Other | Treatment adherence (class/session attendance) | Assess treatment adherence according to attendance during 12 week intervention period. | 12wks | |
Primary | Change from Baseline in Average Pain intensity in previous week | Intensity of pain in previous week as measured on a 10 point numerical scale (0-10). | 12 wks | |
Primary | Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability | Utilize modified 23-point scale standardized Roland Morris questionnaire to asses back pain specific disability. | 12 wks | |
Secondary | Change from baseline in Pain Medication use in the previous week | Specific self-reported pain medication use in previous week. | 12wks | |
Secondary | Satisfaction with assigned intervention at 12 weeks | Self-reported satisfaction with intervention using 5-point Likert scale from very dissatisfied to very satisfied | 12 wks | |
Secondary | Global improvement in back pain at 12 weeks | Self-reported rating of global improvement since start of study using 7-point Likert scale from extremely worsened to extremely improved | 12wks | |
Secondary | Change from Baseline for Health related Quality of Life using SF-36 survey | Use standardized Quality of life SF-36 questionnaire. | 12wks | |
Secondary | Work productivity | Use standardized Work Productivity and Activity Impairment questionnaire to assess employment status and productivity | 12wks |
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