Optimize Low Back Pain

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT03859713

Collaborator

Patient-Centered Outcomes Research Institute (Other)

945

Enrollment

Locations

Arms

52.3

Anticipated Duration (Months)

315

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Chronic Pain	Behavioral: Physical Therapy Behavioral: Cognitive Behavioral Therapy Behavioral: Mindfulness	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

945 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

Actual Study Start Date :

Mar 22, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 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 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

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
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
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
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
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
Health Care Utilization [baseline, 10 weeks, 26 weeks, 52 weeks]
Utilization of surgery, injections, imaging or other discrete interventions for low back pain
Opioid Utilization [baseline, 10 weeks, 26 weeks, 52 weeks]
Use of opioids for pain management
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287
2	Intermountain Health Care	Salt Lake City	Utah	United States	84107
3	The University of Utah Healthcare System	Salt Lake City	Utah	United States	84108