Clinical trial NCT03859713: Optimize Low Back Pain
Official title: Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Low Back Pain
Chronic Pain
Keywords: Physical Therapy
Cognitive Behavioral Therapy
Mindfulness
Adaptive Treatment Regimens
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-03-01
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Oswestry Disability Index from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Oswestry Disability Index from baseline to 52 weeks
timeFrame: baseline, 52 weeks
measure: Change in Numeric Pain Intensity Rating from baseline to 10 weeks
timeFrame: baseline, 10 weeks
measure: Change in Numeric Pain Intensity Rating from baseline to 52 weeks
timeFrame: baseline, 52 weeks
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Pain Interference
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Fatigue
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Sleep Disturbance
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Anxiety
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Depression
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Social Role Participation
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Health Care Utilization
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Opioid Utilization
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
measure: Treatment Side Effects
timeFrame: 10 weeks, 26 weeks
measure: Treatment Responder
timeFrame: baseline, 10 weeks, 26 weeks, 52 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Salt Lake City
country: United States
facility: Intermountain Health Care
state: Utah
city: Salt Lake City
country: United States
facility: The University of Utah Healthcare System
state: Utah
Study officials:
affiliation: University of Utah
name: Julie Fritz, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.