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

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.

Conditions

• Chronic Low-back Pain

Interventions

BEHAVIORAL

Mindfulness 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.

OTHER

Perspectives on pain

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

OTHER

Discussion

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Worcester Polytechnic Institute

  collaborator OTHER

• Boston Medical Center

  lead OTHER

Principal Investigators

• Natalia Morone, MD MS · Boston Medical Center

• Jean King, PhD · Worcester Polytechnic Institute

• Emmanuel Agu, PhD · Worcester Polytechnic Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-25

Primary Completion

2028-09-30

Completion

2029-12-31

Countries

• United States

Study Locations