Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations
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2 other identifiers
interventional
320
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 7, 2019
February 1, 2019
1.7 years
April 20, 2011
February 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Change from baseline in Pain Medication use in the previous week
12wks
Satisfaction with assigned intervention at 12 weeks
12 wks
Global improvement in back pain at 12 weeks
12wks
Change from Baseline for Health related Quality of Life using SF-36 survey
12wks
Work productivity
12wks
Other Outcomes (2)
Number of participants with Adverse Events as a measure of safety and treatment adherence
12wks
Treatment adherence (class/session attendance)
12wks
Study Arms (3)
Yoga
ACTIVE COMPARATOR12 weeks of weekly yoga classes plus 40 weeks of either drop-in classes or home practice.
Physical Therapy
ACTIVE COMPARATOR15 individual physical therapy treatment sessions over 12 weeks plus 40 weeks with either 5 booster sessions or home practice.
Education
ACTIVE COMPARATOR"The Back Pain Helpbook" which gives exercises and tips for self-care pain management.
Interventions
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.
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.
Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.
Eligibility Criteria
You may qualify if:
- Current non-specific low back pain persisting for at least 12 weeks
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Boston Medical Center
Boston, Massachusetts, 02118, United States
South End Community Health Center
Boston, Massachusetts, 02118, United States
Dimock Health Center
Boston, Massachusetts, 02119, United States
Dorchester House MultiService Center
Dorchester, Massachusetts, 02112, United States
Codman Square Health Center
Dorchester, Massachusetts, 02124, United States
Upham's Corner Health Center
Dorchester, Massachusetts, 02125, United States
Greater Roslindale Medical and Dental Center
Roslindale, Massachusetts, 02131, United States
South Boston Community Health Center
South Boston, Massachusetts, 02127, United States
Related Publications (11)
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.
PMID: 19943573BACKGROUNDSaper 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.
PMID: 23878604BACKGROUNDJoyce C, Kelly KC, Gurnani S, Sherman KJ, Roseen EJ, Saper RB. "In Class We Were All One." A Qualitative Exploration of Yoga and Educational Interventions for Predominantly Low-Income and Minority Adults with Chronic Low Back Pain. J Integr Complement Med. 2022 Nov;28(11):870-877. doi: 10.1089/jicm.2022.0557. Epub 2022 Aug 1.
PMID: 35914101DERIVEDJoyce CT, Chernofsky A, Lodi S, Sherman KJ, Saper RB, Roseen EJ. Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain. J Orthop Sports Phys Ther. 2022 Jul;52(7):470-483. doi: 10.2519/jospt.2022.10813. Epub 2022 May 18.
PMID: 35584010DERIVEDMarshall A, Joyce CT, Tseng B, Gerlovin H, Yeh GY, Sherman KJ, Saper RB, Roseen EJ. Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain. Pain Med. 2022 Apr 8;23(4):834-843. doi: 10.1093/pm/pnab318.
PMID: 34698869DERIVEDJoyce C, Roseen EJ, Keysor JJ, Gross KD, Culpepper L, Saper RB. Can Yoga or Physical Therapy for Chronic Low Back Pain Improve Depression and Anxiety Among Adults From a Racially Diverse, Low-Income Community? A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jun;102(6):1049-1058. doi: 10.1016/j.apmr.2021.01.072. Epub 2021 Feb 5.
PMID: 33556352DERIVEDRoseen EJ, Gerlovin H, Felson DT, Delitto A, Sherman KJ, Saper RB. Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial. Pain Med. 2021 Feb 4;22(1):165-180. doi: 10.1093/pm/pnaa153.
PMID: 32662833DERIVEDBerlowitz J, Hall DL, Joyce C, Fredman L, Sherman KJ, Saper RB, Roseen EJ. Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial. Pain Med. 2020 Oct 1;21(10):2529-2537. doi: 10.1093/pm/pnaa150.
PMID: 32500130DERIVEDRoseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.
PMID: 31667747DERIVEDSaper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
PMID: 28631003DERIVEDSaper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
PMID: 24568299DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert B Saper, MD, MPH
Boston University School of Medicine/ Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 28, 2011
Study Start
June 1, 2012
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
February 7, 2019
Record last verified: 2019-02