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Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)

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ClinicalTrials.gov Identifier: NCT01343927
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):

Study Description
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.

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Study Start Date : June 2012
Primary Completion Date : February 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Behavioral: Education
Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.

Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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.

Secondary Outcome Measures :
  1. Change from baseline in Pain Medication use in the previous week [ Time Frame: 12wks ]
    Specific self-reported pain medication use in previous week.

  2. 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

  3. 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

  4. Change from Baseline for Health related Quality of Life using SF-36 survey [ Time Frame: 12wks ]
    Use standardized Quality of life SF-36 questionnaire.

  5. Work productivity [ Time Frame: 12wks ]
    Use standardized Work Productivity and Activity Impairment questionnaire to assess employment status and productivity

Other Outcome Measures:
  1. 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.

  2. Treatment adherence (class/session attendance) [ Time Frame: 12wks ]
    Assess treatment adherence according to attendance during 12 week intervention period.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Boston Medical Center
Principal Investigator: Robert B Saper, MD, MPH Boston University School of Medicine/ Boston Medical Center
More Information

Additional Information:
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: R01AT005956 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Robert B Saper, Boston Medical Center:
Chronic low back pain
Community health center
Physical therapy
Minority populations
Health education

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms