RecruitingNot ApplicableNCT06106191

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


Sponsor

Boston Medical Center

Enrollment

350 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an integrative mindfulness-based approach — combining mindfulness meditation with predictive data — to help treat chronic low back pain that has lasted at least 3 months. It is a remote (online or telephone) intervention. **You may be eligible if...** - You have chronic low back pain that has persisted for at least 3 months and has affected you on at least half the days in the past 6 months - You can give informed consent online or by phone - You speak English - You are a patient at a participating clinic and plan to continue being seen there for at least 6 more months **You may NOT be eligible if...** - You have experienced rapidly worsening pain, unexplained fever, or unexplained weight loss in the past month (these are warning signs that need immediate medical attention) - You are pregnant - You have metastatic cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness meditation

Ordinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities.

OTHERPerspectives on pain

Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.

OTHERDiscussion

Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.


Locations(1)

Boston Medical Center

Boston, Massachusetts, United States

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NCT06106191


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