Optimize Low Back Pain

Completed · Not applicable

Conditions studied: Low Back Pain, Chronic Pain

In brief

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.

Key facts

Study ID

NCT03859713

Run by

University of Utah

People needed

749

Starts

2019-03-22

Expected to finish

2024-10-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Has access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Intermountain Health Care — Salt Lake City, Utah, United States
• The University of Utah Healthcare System — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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