N/A
N=749
Optimize Low Back Pain
Low Back Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03859713 ↗Enrolled (actual)
749
Serious AEs
3.2%
Results posted
Mar 2026
Primary outcome: Primary: Change in Oswestry Disability Index From Baseline to 10 Weeks — -8.8; -6.1 Units on a scale — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Therapy (Behavioral); Cognitive Behavioral Therapy (Behavioral); Mindfulness (Behavioral); Phase I Treatment (Behavioral); Phase II Switching (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oswestry Disability Index From Baseline to 10 Weeks |
-8.8; -6.1 | 0.02 sig |
| PRIMARY Change in Oswestry Disability Index From 10-weeks to 52 Weeks |
-5.4; -4.9 | 0.76 |
| PRIMARY Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks |
-1.2; -0.84 | 0.03 sig |
| PRIMARY Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks |
-0.53; -0.48 | 0.80 |
| SECONDARY Health-related Quality of Life |
— | — |
| SECONDARY Change in Pain Interference From Baseline to 10 Weeks |
-4.0; -2.2 | 0.002 sig |
| SECONDARY Change in Fatigue From Baseline to !0 Weeks |
-1.2; 0.25 | 0.03 sig |
| SECONDARY Change in Sleep Disturbance From Baseline to 10 Weeks |
-2.1; -0.60 | 0.007 sig |
| SECONDARY Change in Anxiety From Baseline to 10 Weeks |
0.43; 2.5 | 0.002 sig |
| SECONDARY Change in Depression From Baseline to 10 Weeks |
1.3; 2.0 | 0.32 |
| SECONDARY Change in Social Role Participation From Baseline to 10 Weeks |
1.9; 0.50 | 0.01 sig |
| SECONDARY Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks |
27; 30 | 0.35 |
| SECONDARY Opioid Utilization at 10-week Assessment |
32; 35 | 0.16 |
| SECONDARY Treatment Side Effects |
46; 24 | 0.032 sig |
| SECONDARY Treatment Responder |
73; 38 | 0.001 sig |
| SECONDARY Health Care Utilization of Injections for Back Pain Over 10 Weeks |
12; 31 | 0.003 sig |
| SECONDARY Health Care Utilization of Radiographs for Back Pain Over 10 Weeks |
14; 16 | 0.50 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03859713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.