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

Phase 3

Waitlist Available

Led By Julie Fritz, PT, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4

At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10 weeks, 26 weeks, 52 weeks

Awards & highlights

OPTIMIZE Trial Summary

This trial is testing whether physical therapy or cognitive behavioral therapy is more effective for chronic lower back pain, and whether mindfulness is more effective for those who don't respond to the first two treatments.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While this trial focuses on non-drug therapies which typically have fewer side effects than medications, participants may experience discomfort during physical therapy exercises or emotional distress during CBT or mindfulness sessions.

OPTIMIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience significant pain and disability.

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

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I am between 18 and 64 years old.

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I have been diagnosed with chronic lower back pain.

OPTIMIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10 weeks, 26 weeks, 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10 weeks, 26 weeks, 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 weeks, 26 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Numeric Pain Intensity Rating from baseline to 10 weeks

Change in Numeric Pain Intensity Rating from baseline to 52 weeks

Change in Oswestry Disability Index from baseline to 10 weeks

+1 more

Secondary outcome measures

Anxiety

Depression

Fatigue

+8 more

OPTIMIZE Trial 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1460

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Mindfulness

2014

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,777,882 Total Patients Enrolled

27 Trials studying Chronic Pain

3,785 Patients Enrolled for Chronic Pain

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,995,800 Total Patients Enrolled

9 Trials studying Chronic Pain

6,542 Patients Enrolled for Chronic Pain

Julie Fritz, PT, PhDPrincipal Investigator - University of Utah

University of Utah

2 Previous Clinical Trials

245 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prerequisites for joining this clinical trial?

"This study is looking for 748 participants between the ages of 18 and 64 who have low back pain. In order to be eligible, participants must also meet the following criteria:-Have access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits.-Meet 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"

Answered by AI

Are investigators looking for more participants for this clinical trial?

"Yes, this experiment is looking for individuals who are willing to take part in it. The listing was first published on March 22, 2019 and the most recent update was on September 1, 2022."

Answered by AI

What are the investigators hoping to discover through this research?

"The primary goal of this 52-week clinical trial is to observe a change in the Numeric Pain Intensity Rating from baseline to 10 weeks. Other notable objectives, or secondary outcomes, include measuring the Opioid Utilization, Health-related Quality of Life, and Depression."

Answered by AI

Does the FDA endorse physical therapy as an effective medical treatment?

"There is some evidence that physical therapy is effective and multiple rounds of data supporting safety, so it received a score of 3."

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Does this research include participants who are 20 or older?

"Eligibility for this clinical trial is reserved for those aged 18 to 64. There are 43 other trials available for minors and 616 for senior citizens."

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