Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Weekly yoga classes; Individual physical therapy treatment; Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic low back pain; Community health center; Yoga; Physical therapy; Minority populations; Health education