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.

  Hide Detailed Description

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.

  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 August 28, 2014