Multimodal Back Pain Therapies for Chronic Lower Back Pain
(BEST Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byDaniel Clauw, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a NIAMS-sponsored clinical trial being conducted through the NIH HEAL Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating the optimal treatment or combination of treatments based on patient features and response to the initial treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.

Research Team

Kevin Anstrom, PhD

Principal Investigator

UNC Chapel Hill

Matthew Mauck, PhD

Principal Investigator

UNC Chapel Hill

Gwendolyn Sowa, PhD

Principal Investigator

University of Pittsburgh

Daniel Clauw, MD

Principal Investigator

University of Michigan

Eligibility Criteria

The BEST Trial is for adults with chronic lower back pain lasting at least 3 months, who can participate in a 9-month study. They must be able to use email and internet-enabled devices, understand English, and not be excluded due to certain medical conditions or ongoing legal issues.

Inclusion Criteria

Meet Run-in period engagement eligibility criteria: Completion of two Run-in study information modules prior to period 1 randomization (Visit 0)

Available to complete the full study protocol (approximately 9 months)

I can receive and respond to study emails.

See 11 more

Exclusion Criteria

Criterion: If you have any of the following conditions, you can't participate: progressive neurodegenerative disease, spine infection or tumor, certain types of arthritis or autoimmune diseases, specific spinal cord or nerve issues, recent vertebral fracture or osteoporosis needing medication, bone-related cancer, current or recent non-skin cancer treatment, significant vision or hearing problems, uncontrolled drug or alcohol addiction, ongoing disability or injury-related legal matters, current participation in another pain study, or any other condition that the study doctor thinks would make it unsafe for you to take part.

Pregnant at the time of Visit 0 (Baseline)

Treatment Details

Interventions

Acceptance and Commitment Therapy (ACT) (Behavioral Intervention)
Duloxetine (Selective Serotonin-Norepinephrine Reuptake Inhibitor)
Enhanced Self-Care (ESC) (Behavioral Intervention)
Evidence-Based Exercise and Manual Therapy (EBEM) (Behavioral Intervention)

Trial OverviewThis trial evaluates four treatments for chronic low-back pain: enhanced self-care (ESC), acceptance and commitment therapy (ACT), evidence-based exercise/manual therapy (EBEM), and the medication duloxetine. It aims to develop personalized treatment plans based on individual responses.

Participant Groups

4Treatment groups

Active Control

Group I: Treatment Period 1: Enhanced Self-Care (ESC)Active Control1 Intervention

This arm includes participants who are randomized to ESC in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ESC or be randomized to augment ESC with an additional treatment during Treatment Period 2.

Group II: Treatment Period 1: DuloxetineActive Control1 Intervention

This arm includes participants who are randomized to Duloxetine in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on Duloxetine, augment Duloxetine with an additional treatment, or switch to a new treatment during Treatment Period 2.

Group III: Treatment Period 1: Acceptance and Commitment Therapy (ACT)Active Control1 Intervention

This arm includes participants who are randomized to ACT in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ACT, augment ACT with an additional treatment, or switch to a new treatment during Treatment Period 2.

Group IV: Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)Active Control1 Intervention

This arm includes participants who are randomized to EBEM in Treatment Period 1. Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on EBEM, augment EBEM with an additional treatment, or switch to a new treatment during Treatment Period 2.