Optimize Low Back Pain
CompletedNot applicableNCT03859713
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
- Conditions
- Interventions
- Behavioral: Physical Therapy
- Behavioral: Cognitive Behavioral Therapy
- Behavioral: Mindfulness
- Behavioral: Phase I Treatment
- Behavioral: Phase II Switching
- Sponsor
- University of Utah
- Collaborators
- Patient-Centered Outcomes Research Institute
- Start date
- 2019-03-22
- Primary completion
- 2024-10-01
- Sex
- All
- Age range
- from 18 Years to 64 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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. * Has access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits. 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03859713