NCT03859713

Optimize Low Back Pain

Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 749 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Low Back Pain
• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Physical Therapy	Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
BEHAVIORAL	Cognitive Behavioral Therapy	Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
BEHAVIORAL	Mindfulness	Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
BEHAVIORAL	Phase I Treatment	Includes all participants receiving any Phase I intervention
BEHAVIORAL	Phase II Switching	Includes all participants receiving Switching as Phase II intervention

Timeline

• Start date: 2019-03-22
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2019-03-01
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

3 sites across 1 country: United States