Optimize Low Back Pain

Phase 3

Active, not recruiting

• Conditions: Low Back Pain; Chronic Pain
• Interventions: Behavioral: Physical Therapy; Behavioral: Cognitive Behavioral Therapy; Behavioral: Mindfulness

• Registration Number: NCT03859713
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2019-03-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 748

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PT followed by Mindfulness in Phase II for nonresponders	Physical Therapy	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.
PT followed by Switching to CBT in Phase II for nonresponders	Physical Therapy	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.
CBT followed by Switching to PT in Phase II for nonresponders	Physical Therapy	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.
CBT followed by Switching to PT in Phase II for nonresponders	Cognitive Behavioral Therapy	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.
PT followed by Switching to CBT in Phase II for nonresponders	Cognitive Behavioral Therapy	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.
CBT followed by Mindfulness in Phase II for nonresponders	Mindfulness	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.
PT followed by Mindfulness in Phase II for nonresponders	Mindfulness	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.
CBT followed by Mindfulness in Phase II for nonresponders	Cognitive Behavioral Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index from baseline to 52 weeks	baseline, 52 weeks	Back pain specific measure of functional disability to address Aim 2
Change in Numeric Pain Intensity Rating from baseline to 10 weeks	baseline, 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.
Change in Oswestry Disability Index from baseline to 10 weeks	baseline, 10 weeks	Back pain specific measure of functional disability to address Aim 1
Change in Numeric Pain Intensity Rating from baseline to 52 weeks	baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10
Opioid Utilization	baseline, 10 weeks, 26 weeks, 52 weeks	Use of opioids for pain management
Fatigue	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Sleep Disturbance	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Social Role Participation	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Depression	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Health Care Utilization	baseline, 10 weeks, 26 weeks, 52 weeks	Utilization of surgery, injections, imaging or other discrete interventions for low back pain
Health-related Quality of Life	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS-29 score assessed as a T-score with mean = 50 and SD = 10
Pain Interference	baseline, 10 weeks, 26 weeks, 52 weeks	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Treatment Side Effects	10 weeks, 26 weeks	Self-reported physical or psychological side effects of study treatments
Treatment Responder	baseline, 10 weeks, 26 weeks, 52 weeks	Dichotomous outcome based on achieving at least 50% improvement on ODI from baselin score

Trial Locations

Locations (3)

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