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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
749
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
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 10 weeks, 52 weeks
Health-related Quality of Life
PROMIS-29 subscales scores reported across 7 domains
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 10 weeks
Treatment Side Effects
Self-reported physical or psychological side effects of study treatments
Time frame: 10 weeks
Treatment Responder
Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score
Time frame: baseline, 10 weeks
Health Care Utilization of Injections for Back Pain Over 10 Weeks
Use of injections for low back pain
Time frame: baseline, 10 weeks
Health Care Utilization of Radiographs for Back Pain Over 10 Weeks
Use of radiographs for low back pain
Time frame: baseline, 10 weeks
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