Optimize Low Back Pain
OPTIMIZE
Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
1 other identifier
interventional
749
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Mar 2019
Longer than P75 for not_applicable low-back-pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedResults Posted
Study results publicly available
March 6, 2026
CompletedMarch 6, 2026
February 1, 2026
5.5 years
February 26, 2019
August 2, 2025
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Oswestry Disability Index From Baseline to 10 Weeks
Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
baseline, 10 weeks
Change in Oswestry Disability Index From 10-weeks to 52 Weeks
Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability
10 weeks, 52 weeks
Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity.
baseline, 10 weeks
Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity.
10 weeks, 52 weeks
Secondary Outcomes (13)
Health-related Quality of Life
baseline, 10 weeks, 26 weeks, 52 weeks
Change in Pain Interference From Baseline to 10 Weeks
baseline, 10 weeks
Change in Fatigue From Baseline to !0 Weeks
baseline, 10 weeks
Change in Sleep Disturbance From Baseline to 10 Weeks
baseline, 10 weeks
Change in Anxiety From Baseline to 10 Weeks
baseline, 10 weeks
- +8 more secondary outcomes
Study Arms (8)
PT followed by Switching to CBT in Phase II for nonresponders
EXPERIMENTALPhase 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.
PT followed by Mindfulness in Phase II for nonresponders
EXPERIMENTALPhase 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.
CBT followed by Switching to PT in Phase II for nonresponders
EXPERIMENTALPhase 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.
CBT followed by Mindfulness in Phase II for nonresponders
EXPERIMENTALPhase 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.
Phase I PT Treatment
ACTIVE COMPARATORThis arm includes participants assigned to PT as their Phase I treatment
Phase I CBT Treatment
ACTIVE COMPARATORThis arm includes participants assigned to CBT for their Phase I treatment
Phase II Switching Treatment
ACTIVE COMPARATORIncludes all Non-Responders in Phase I who were re-randomized to Switch in Phase II
Phase II Mindfulness Treatment
ACTIVE COMPARATORInclude all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II
Interventions
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual 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
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
Includes all participants receiving any Phase I intervention
Includes all participants receiving Switching as Phase II intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (3)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Intermountain Health Care
Salt Lake City, Utah, 84107, United States
The University of Utah Healthcare System
Salt Lake City, Utah, 84108, United States
Related Publications (3)
Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z.
PMID: 32393216BACKGROUNDFritz JM, Greene T, Brennan GP, Minick K, Lane E, Wegener ST, Skolasky RL. Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME). Trials. 2023 Feb 23;24(1):137. doi: 10.1186/s13063-023-07150-1.
PMID: 36823645DERIVEDFritz JM, Lane E, Minick KI, Bardsley T, Brennan G, Hunter SJ, McGee T, Rassu FS, Wegener ST, Skolasky RL. Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. Telemed Rep. 2021 Nov 3;2(1):258-263. doi: 10.1089/tmr.2021.0028. eCollection 2021.
PMID: 34927165DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Our study has limitations. Treatment initiations rates were low, reducing the treatment dose for participants. COVID caused a suspension of enrollment for 13 months, requiring a reduction in the target sample size. While sufficient power was retained for the co-primary aims, the power for some secondary and exploratory aims was impacted. Finally, our study design did not include a treatment as usual condition for comparison with our study treatments and embedded adaptive interventions.
Results Point of Contact
- Title
- Dr. Julie Fritz
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Fritz, PT, PhD
University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and clinicians cannot be blind to treatment received. The investigators will remain blind to group assignment and follow-up assessments will be conducted by assessors who are blind to treatment group.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
February 26, 2019
First Posted
March 1, 2019
Study Start
March 22, 2019
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
March 6, 2026
Results First Posted
March 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share