Optimize Low Back Pain

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    945
  • sponsor
    University of Utah
Updated on 23 January 2021
combinations
behavior therapy
back pain
cognitive therapy
manual therapy

Summary

The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.

Description

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.

Details
Condition Low Back Pain, Back Pain, Pain, Chronic Back Pain, Chronic Pain, Post-Surgical Pain, Pain (Pediatric), Lower Back Pain, chronic pains, lumbago
Treatment Cognitive behavioral therapy, Physical therapy, Mindfulness
Clinical Study IdentifierNCT03859713
SponsorUniversity of Utah
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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