Optimize Low Back Pain

Chronic Pain Clinical Trial

— OPTIMIZE  

Official title:

Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03859713
• Other study ID #: 00116150
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 22, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 748
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Behavioral:
• Physical Therapy
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
• 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
• Mindfulness
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index from baseline to 10 weeks	Back pain specific measure of functional disability to address Aim 1	baseline, 10 weeks
Primary	Change in Oswestry Disability Index from baseline to 52 weeks	Back pain specific measure of functional disability to address Aim 2	baseline, 52 weeks
Primary	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.	baseline, 10 weeks
Primary	Change in Numeric Pain Intensity Rating from baseline 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.	baseline, 52 weeks
Secondary	Health-related Quality of Life	PROMIS-29 score assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Pain Interference	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Fatigue	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Sleep Disturbance	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Anxiety	PROMIS 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Depression	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Social Role Participation	PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Health Care Utilization	Utilization of surgery, injections, imaging or other discrete interventions for low back pain	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Opioid Utilization	Use of opioids for pain management	baseline, 10 weeks, 26 weeks, 52 weeks
Secondary	Treatment Side Effects	Self-reported physical or psychological side effects of study treatments	10 weeks, 26 weeks
Secondary	Treatment Responder	Dichotomous outcome based on achieving at least 50% improvement on ODI from baselin score	baseline, 10 weeks, 26 weeks, 52 weeks