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

Phase 4

Waitlist Available

Led By Daniel Clauw, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months

Low-back pain more severe than pain in other parts of the body

Must not have

Affirmative participant response to any of the following conditions: Progressive neurodegenerative disease, History of discitis osteomyelitis (spine infection) or spine tumor, History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus, History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing), Diagnosis of any vertebral fracture in the last 6 months, Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates, History of any bone-related cancer or cancer that metastasized to the bone, Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months, History of any non-skin cancer treatment in the last 24 months, Visual or hearing difficulties that would preclude participation, Uncontrolled drug/alcohol addiction, Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation, Currently participating in another interventional pain study, Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24 weeks

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking to find the best possible treatment for chronic low back pain by testing different interventions and seeing which one works best for each individual based on their specific markers and response to treatment.

Who is the study for?

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.

What is being tested?

This 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.

What are the potential side effects?

Duloxetine may cause nausea, dry mouth, sleepiness, constipation, loss of appetite, and increased sweating. Exercise/therapy could result in muscle soreness or strain. ACT typically has no side effects but might bring up uncomfortable emotions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had low-back pain for at least 3 months, happening often.

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My low-back pain is worse than pain in any other part of my body.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Pain Intensity and Interference Score

Secondary study objectives

Anxiety Score

Depression Score

Incidence of Any Opioid Use

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 4Eligibility criteria met