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

NCT ID: NCT01343927

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Back Pain Lower Back Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yoga

12 weeks of weekly yoga classes plus 40 weeks of either drop-in classes or home practice.

Group Type: ACTIVE_COMPARATOR

Weekly yoga classes

Intervention Type: BEHAVIORAL

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.

Physical Therapy

15 individual physical therapy treatment sessions over 12 weeks plus 40 weeks with either 5 booster sessions or home practice.

Group Type: ACTIVE_COMPARATOR

Individual physical therapy treatment

Intervention Type: BEHAVIORAL

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.

Education

"The Back Pain Helpbook" which gives exercises and tips for self-care pain management.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Education

Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.

Intervention Type: BEHAVIORAL

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert B Saper, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University School of Medicine/ Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

South End Community Health Center

Boston, Massachusetts, United States

Dimock Health Center

Boston, Massachusetts, United States

Dorchester House MultiService Center

Dorchester, Massachusetts, United States

Codman Square Health Center

Dorchester, Massachusetts, United States

Upham's Corner Health Center

Dorchester, Massachusetts, United States

Greater Roslindale Medical and Dental Center

Roslindale, Massachusetts, United States

South Boston Community Health Center

South Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19943573 (View on PubMed)

Saper 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.

Reference Type: BACKGROUND

PMID: 23878604 (View on PubMed)

Joyce 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.

Reference Type: DERIVED

PMID: 35914101 (View on PubMed)

Joyce 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.

Reference Type: DERIVED

PMID: 35584010 (View on PubMed)

Marshall 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.

Reference Type: DERIVED

PMID: 34698869 (View on PubMed)

Joyce 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.

Reference Type: DERIVED

PMID: 33556352 (View on PubMed)

Roseen 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.

Reference Type: DERIVED

PMID: 32662833 (View on PubMed)

Berlowitz 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.

Reference Type: DERIVED

PMID: 32500130 (View on PubMed)

Roseen 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.

Reference Type: DERIVED

PMID: 31667747 (View on PubMed)

Saper 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.

Reference Type: DERIVED

PMID: 28631003 (View on PubMed)

Saper 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.

Reference Type: DERIVED

PMID: 24568299 (View on PubMed)

Related Links

http://www.bu.edu/integrativemed

Program for Integrative Medicine and Health Disparities at Boston Medical Center

Other Identifiers

H-29779

Identifier Type: -

Identifier Source: org_study_id

R01AT005956

Identifier Type: NIH

Identifier Source: secondary_id

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