← Back to Search

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.
Must not have
Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc
Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease, vertebral osteomyelitis, etc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 weeks, 26 weeks, 52 weeks
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience significant pain and disability.
Select...
I experience significant pain and disability, with a pain score over 4.
Select...
I am between 18 and 64 years old.
Select...
I have been diagnosed with chronic lower back pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My lower back pain is due to a diagnosed spine condition.
Select...
My lower back pain is not caused by serious conditions like cancer or infections.
Select...
I have had lumbar spine surgery in the last year.

Timeline

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

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
~1280
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Mindfulness
2014
Completed Phase 3
~2650

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,787,808 Total Patients Enrolled
28 Trials studying Chronic Pain
4,085 Patients Enrolled for Chronic Pain
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,991,402 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
~12 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top