Optimize Low Back Pain (OPTIMIZE)

Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Physical Therapy; Behavioral: Cognitive Behavioral Therapy; Behavioral: Mindfulness; Behavioral: Phase I Treatment; Behavioral: Phase II Switching

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.

• Study Type: Interventional
• Enrollment (Actual): 749
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • The University of Utah Healthcare System
    • Salt Lake City, Utah, United States, 84107
      • Intermountain Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT followed by Switching to CBT in Phase II for nonresponders; 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.	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
Experimental: PT followed by Mindfulness in Phase II for nonresponders; 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.	Behavioral: Physical Therapy; Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.; Behavioral: Mindfulness; Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.; Other Names: Mindfulness-Oriented Recovery Enhancement
Experimental: CBT followed by Switching to PT in Phase II for nonresponders; 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.	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
Experimental: CBT followed by Mindfulness in Phase II for nonresponders; 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.	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.; Other Names: Mindfulness-Oriented Recovery Enhancement
Active Comparator: Phase I PT Treatment; This arm includes participants assigned to PT as their Phase I treatment	Behavioral: Physical Therapy; Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
Active Comparator: Phase I CBT Treatment; This arm includes participants assigned to CBT for their Phase I treatment	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
Active Comparator: Phase II Switching Treatment; Includes all Non-Responders in Phase I who were re-randomized to Switch in Phase II	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
Active Comparator: Phase II Mindfulness Treatment; Include all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II	Behavioral: Mindfulness; Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.; Other Names: Mindfulness-Oriented Recovery Enhancement; Behavioral: Phase I Treatment; Includes all participants receiving any Phase I intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life	PROMIS-29 subscales scores reported across 7 domains	baseline, 10 weeks, 26 weeks, 52 weeks
Change in Pain Interference From Baseline to 10 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference.	baseline, 10 weeks
Change in Fatigue From Baseline to !0 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue.	baseline, 10 weeks
Change in Sleep Disturbance From Baseline to 10 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance	baseline, 10 weeks
Change in Anxiety From Baseline to 10 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety	baseline, 10 weeks
Change in Depression From Baseline to 10 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression	baseline, 10 weeks
Change in Social Role Participation From Baseline to 10 Weeks	Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles	baseline, 10 weeks
Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks	Use of either MRI or CT for low back pain	baseline, 10 weeks
Opioid Utilization at 10-week Assessment	Long-term use of opioids for pain management defined as use on all or most days in the past 90 days	baseline, 10 weeks
Treatment Side Effects	Self-reported physical or psychological side effects of study treatments	10 weeks
Treatment Responder	Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score	baseline, 10 weeks
Health Care Utilization of Injections for Back Pain Over 10 Weeks	Use of injections for low back pain	baseline, 10 weeks
Health Care Utilization of Radiographs for Back Pain Over 10 Weeks	Use of radiographs for low back pain	baseline, 10 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Julie Fritz, PT, PhD, University of Utah

Publications and helpful links

General Publications

• 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.
• Fritz 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.
• Fritz 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Physical Therapy; Cognitive Behavioral Therapy; Adaptive Treatment Regimens
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Low Back Pain; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Cognitive Behavioral Therapy; Mindfulness; Physical Therapy Modalities
• Other Study ID Numbers: 00116150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No