Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert B Saper, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01343927
First received: April 20, 2011
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


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: November 2014
Estimated Primary Completion Date: February 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
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: NCT01343927

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Dimock Health Center
Boston, Massachusetts, United States, 02119
Codman Square Health Center
Dorchester, Massachusetts, United States, 02124
Upham's Corner Health Center
Dorchester, Massachusetts, United States, 02125
Dorchester House MultiService Center
Dorchester, Massachusetts, United States, 02112
Greater Roslindale Medical and Dental Center
Roslindale, Massachusetts, United States, 02131
South Boston Community Health Center
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 20, 2013
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 October 01, 2014