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Recruiting NCT06106191

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

◆ AI Clinical Summary

This study uses artificial intelligence to identify unique biological, psychological, and social factors that contribute to your chronic low back pain. Researchers will use these personalized signatures to predict how well mindfulness-based treatment will work for you.

Key Objective: The trial tests whether personalized predictions based on your individual pain markers can help match you with the most effective mindfulness treatment for chronic low back pain.

Who to Consider: People with chronic low back pain who are interested in mindfulness-based approaches and willing to participate in personalized treatment prediction research should consider enrolling.

Trial Parameters

Condition Chronic Low-back Pain
Sponsor Boston Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-25
Completion 2028-09
Interventions
Mindfulness meditationPerspectives on painDiscussion

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months * Willing and able to provide online or telephone informed consent * Speak English as the intervention manual is currently written in English Exclusion Criteria: * Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss * Pregnancy * Metastatic cancer * Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months

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