Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment

This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain. The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment. The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

NCT Number	NCT06106191
Lead Sponsor	Boston Medical Center Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Worcester Polytechnic Institute
Conditions	Chronic Low-back Pain
Enrollment	350 participants
Start Date	2024-07-25
Primary Completion	2028-09 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-30