Status:
UNKNOWN
Optimize Low Back Pain
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Low Back Pain
Chronic Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief 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 accomplis...
Detailed 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 week...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
748 Patients enrolled
Trial Details
Trial ID
NCT03859713
Start Date
March 22 2019
End Date
September 1 2024
Last Update
October 4 2023
Active Locations (3)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Intermountain Health Care
Salt Lake City, Utah, United States, 84107
3
The University of Utah Healthcare System
Salt Lake City, Utah, United States, 84108