Optimize Low Back Pain

The study uses a sequential multiple randomization (SMART) design. The study will compare the
effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment
will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to
complete treatment. At the 10-week assessment researchers will examine if the patient has
responded to initial treatment using a patient-centered, validated definition of successful
response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are
responders to initial treatment will receive up to 2 additional sessions of the same
treatment to assist transition to self-management. Non-responders will be re-randomized to a
second treatment strategy of either switching to the other initial treatment (i.e., patients
receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also
8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment.

The study has two co-primary outcomes; function and pain. The investigators will use the ODI,
a well-validated, reliable and responsive patient-reported measure of LBP-related function
recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity
with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings
are made for current, worst and best pain over the past 24 hours with an average computed to
represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work
and healthcare utilization.

Inclusion Criteria:

- Age 18 - 64 years at the time of enrollment.

- Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has
LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing
problem for you over the past 6 months? A response of greater than 3 months to
question 1, and "at least half the days in the past 6 months" to question 2 is
required to satisfy the NIH definition of chronic LBP.

- Healthcare visit for LBP in the past 90 days.

- At least moderate levels of pain and disability requiring ODI score >24 and pain
intensity rating > 4.

Exclusion Criteria:

- Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory
disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.

- Evidence of a specific spinal pathology as the cause of LBP including spine fracture,
spinal stenosis, radiculopathy, etc.

- Knowingly pregnant

- Has received physical therapy for LBP; or CBT or mindfulness for any reason with a
provider in prior 90 days

- Currently receiving substance use disorder treatment

- Any lumbar spine surgery in the past year.