Optimize Low Back Pain

NCT ID: NCT03859713

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2024-09-01

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.

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.

Conditions

Low Back Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: BEHAVIORAL

Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: BEHAVIORAL

Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Mindfulness

Intervention Type: BEHAVIORAL

Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: BEHAVIORAL

Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.

Interventions

Physical Therapy

Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Mindfulness

Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindfulness-Oriented Recovery Enhancement

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Julie Fritz

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Fritz, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Intermountain Health Care

Salt Lake City, Utah, United States

The University of Utah Healthcare System

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32393216 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36823645 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34927165 (View on PubMed)

Other Identifiers

00116150

Identifier Type: -

Identifier Source: org_study_id