title: Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown.
  
  
  METHODS
  This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data.
  
  
  BACKGROUND
  This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.
authors.affiliation: Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118, USA. robert.saper@bmc.org.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Saper
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Sherman
authors.forename: Anthony
authors.initials: A
authors.lastname: Delitto
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Herman
authors.forename: Joel
authors.initials: J
authors.lastname: Stevans
authors.forename: Ruth
authors.initials: R
authors.lastname: Paris
authors.forename: Julia E
authors.initials: JE
authors.lastname: Keosaian
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Cerrada
authors.forename: Chelsey M
authors.initials: CM
authors.lastname: Lemaster
authors.forename: Carol
authors.initials: C
authors.lastname: Faulkner
authors.forename: Maya
authors.initials: M
authors.lastname: Breuer
authors.forename: Janice
authors.initials: J
authors.lastname: Weinberg
mesh_terms: D001900:Boston; D059350:Chronic Pain / Q000175:diagnosis / Q000191:economics / Q000208:ethnology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003151:Community Health Centers; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology*; D006786:Hospitals, Urban; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000191:economics / Q000208:ethnology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008913:Minority Groups / Q000523:psychology*; D010147:Pain Measurement; D010353:Patient Education as Topic / Q000191:economics; D026741:Physical Therapy Modalities / Q000191:economics; D011203:Poverty / Q000208:ethnology; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D015013:Yoga