Physical Therapy, Cognitive Behavioral Therapy, and Mindfulness for Lower Back Pain (OPTIMIZE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByJulie Fritz, PT, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

This trial is for adults aged 18-64 with chronic lower back pain who have moderate to severe pain and disability, haven't had certain treatments in the past 90 days, and can use video tech for telehealth. It's not for those with specific spinal pathologies, recent lumbar surgery, or serious underlying conditions.

Inclusion Criteria

I experience significant pain and disability.

I experience significant pain and disability, with a pain score over 4.

I am between 18 and 64 years old.

I have been diagnosed with chronic lower back pain.

Exclusion Criteria

My lower back pain is due to a diagnosed spine condition.

My lower back pain is not caused by serious conditions like cancer or infections.

I have had lumbar spine surgery in the last year.

Participant Groups

The study tests if physical therapy (PT) or cognitive behavioral therapy (CBT) helps chronic lower back pain first; then if ineffective, whether switching therapies or adding mindfulness works better. The effectiveness is judged by patient-centered outcomes using a SMART design.

4Treatment groups

Experimental Treatment

Group I: PT followed by Switching to CBT in Phase II for nonrespondersExperimental Treatment2 Interventions

Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.

Group II: PT followed by Mindfulness in Phase II for nonrespondersExperimental Treatment2 Interventions

Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.

Group III: CBT followed by Switching to PT in Phase II for nonrespondersExperimental Treatment2 Interventions

Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.

Group IV: CBT followed by Mindfulness in Phase II for nonrespondersExperimental Treatment2 Interventions

Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:

🇪🇺 Approved in European Union as Cognitive Behavioral Therapy for: