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An Interventional Response Phenotyping Study in Chronic Low Back Pain: Protocol for a Mechanistic Randomized
Afton L Hassett1, David A Williams1, Richard E Harris1
1Department of Anesthesiology, University of Michigan, Ann Arbor, MI 48106, United States.
Pain Medicine (Malden, Mass.)
|January 28, 2023
Summary
This study uses response phenotyping to personalize chronic low back pain treatments. Identifying patient subgroups and predictive measures will improve targeted, effective pain management strategies.
Area of Science:
- Pain Medicine
- Clinical Research
- Translational Science
Background:
- Chronic low back pain (cLBP) treatments are effective for a limited patient subset.
- Current clinical practice lacks guidance for selecting optimal cLBP treatments per individual.
- Understanding differential treatment response is crucial for personalized pain management.
Purpose of the Study:
- To conduct an interventional response phenotyping study for cLBP.
- To identify patient subgroups that respond differentially to evidence-based cLBP treatments.
- To determine if clinical and experimental measures can predict treatment responsiveness.
Main Methods:
- A randomized controlled Sequential, Multiple Assessment, Randomized Trial (SMART) design with 400 cLBP patients.
- A 4-week run-in with a web-based self-management program.
- Randomization to mindfulness-based stress reduction, physical therapy, acupressure, or duloxetine, with potential re-randomization.
Main Results:
- The study aims to identify distinct patient phenotypes responding to specific cLBP interventions.
- It will validate existing clinical measures for predicting treatment response.
- Deeper phenotyping will explore novel biomarkers and mechanisms of action.
Conclusions:
- Interventional response phenotyping can stratify cLBP patients for tailored treatments.
- Predictive measures are essential for optimizing therapeutic outcomes in cLBP.
- This approach holds promise for advancing personalized pain medicine.
