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

February 5, 2019 updated by: Boston Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic low back pain (CLBP) affects 5-10% of U.S. adults annually and disproportionately impacts individuals from minority and low income backgrounds due to disparities in access and treatment. Our previous Yoga Dosing Study of 95 adults with chronic low back pain recruited from Boston Medical Center and affiliated community health centers showed that both once per week and twice per week yoga classes for 12 weeks were similarly effective for reducing pain and improving back related function. We concluded that due to the superior convenience and lower cost of once per week compared to twice per week classes, a once per week yoga protocol was optimal for the current study. Evidence from multiple studies supports a moderate benefit in CLBP for exercise therapy individually-delivered by a physical therapist. Moreover, physical therapy is the most common, reimbursed, non-pharmacologic treatment recommended by physicians for CLBP. However, no studies to date have done a head-to-head comparison of the effectiveness of yoga and physical therapy for CLBP. To ultimately reduce disparities in CLBP for minority populations, patients, providers, and health insurers need to know how a complementary therapy such as yoga compares in effectiveness to more well established treatments such as physical therapy (PT) and education. If yoga is superior to education and has similar effectiveness as PT but costs less with greater adherence, the potential therapeutic and economic implications would be substantial. Alternatively, if yoga is inferior, this information will help guide better treatment decisions and reduce unnecessary expenditures on inferior treatments.

The present study (Back to Health) is a 52 week comparative effectiveness randomized controlled trial of once per week yoga classes, individually delivered physical therapy (PT), and education for chronic low back pain (CLBP) in 320 individuals from predominantly minority backgrounds recruited from Boston Medical Center and affiliated community health centers. The 52 week trial starts with an initial 12 week Treatment Phase followed by a 40 week Maintenance Phase. Back to Health has the following three specific aims:

  1. In the 12 week Treatment Phase, we will enroll 320 adults with chronic low back pain(CLBP) from predominately low-income minority communities and compare the effectiveness (co-primary endpoints pain and function) between (1) a standardized protocol of one yoga class per week; (2) a standardized exercise therapy protocol based on an evidence-based clinical guidelines individually delivered by a physical therapist; and (3) an educational book on self-care for CLBP
  2. For adults with CLBP who have completed the initial 12 week yoga or physical therapy(PT) Treatment Phases, compare effectiveness (co-primary endpoints pain and function)between patients participating in a structured yoga maintenance program, a structured PT maintenance program, or no structured maintenance program.
  3. Determine the cost-effectiveness of yoga, PT, and education for adults with CLBP at 12 weeks, 6 months, 9 months, and one year from three perspectives: society, third party payers, and the participant.

For the 12 week Treatment Phase, participants are randomized in a 2:2:1 ratio into (1) a standardized once per week hatha yoga class supplemented by home practice; (2) a standardized evidence-based exercise therapy protocol individually delivered by a physical therapist and supplemented by home practice; and (3) education delivered through a self-care book. The study co-primary endpoints are mean pain intensity over the previous week measured on a 11 point numerical rating scale and back-specific function measured using the 23 point modified Roland Morris Disability Questionnaire. We hypothesize: (1) yoga will be noninferior to physical therapy; and (2) both yoga and physical therapy will be superior to education.

For the 40 week Maintenance Phase, yoga participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance yoga program or no maintenance yoga program. Similarly, physical therapy participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance PT program or no maintenance PT program. Education participants will be encouraged to continue to review and follow the recommendations of their educational materials. We hypothesize: (1) maintenance yoga will be non-inferior to maintenance PT; (2) maintenance yoga and maintenance PT will be superior to no yoga maintenance and no PT maintenance, respectively; and (3) maintenance yoga and maintenance PT will both be superior to education.

We will also take advantage of a comprehensive integrated set of patient databases, self-report cost data, and study records to compare at 3 months, 6 months, 9 months, and one year the cost-effectiveness of yoga, physical therapy, and education from three perspectives: society,third-party payer, and the participant. Qualitative data from interviews and focus groups will add subjective detail to complement quantitative data.

Results from the Back to Health Study will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02118
        • South End Community Health Center
      • Boston, Massachusetts, United States, 02119
        • Dimock Health Center
      • Dorchester, Massachusetts, United States, 02112
        • Dorchester House MultiService Center
      • Dorchester, Massachusetts, United States, 02124
        • Codman Square Health Center
      • Dorchester, Massachusetts, United States, 02125
        • Upham's Corner Health Center
      • Roslindale, Massachusetts, United States, 02131
        • Greater Roslindale Medical and Dental Center
      • South Boston, Massachusetts, United States, 02127
        • South Boston Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 treatment 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 wks
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.
12 wks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Pain Medication use in the previous week
Time Frame: 12wks
Specific self-reported pain medication use in previous week.
12wks
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
12 wks
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
12wks
Change from Baseline for Health related Quality of Life using SF-36 survey
Time Frame: 12wks
Use standardized Quality of life SF-36 questionnaire.
12wks
Work productivity
Time Frame: 12wks
Use standardized Work Productivity and Activity Impairment questionnaire to assess employment status and productivity
12wks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12wks
Treatment adherence (class/session attendance)
Time Frame: 12wks
Assess treatment adherence according to attendance during 12 week intervention period.
12wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Robert B Saper, MD, MPH, Boston University School of Medicine/ Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-29779
  • R01AT005956 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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