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

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.

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