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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT06106191
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Low-back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness meditation — BEHAVIORAL
    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.
  • Perspectives on pain — OTHER
    Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.
  • Discussion — OTHER
    Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.

Study Details

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.

Key Dates

Start date
Jul 25, 2024
Status verified
Jun 2025
Primary completion
Sep 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
350 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness based stress reduction (MBSR) program
    Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.

Primary Outcome Measure

Pain, Enjoyment, General activity (PEG) composite score [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02116
Natalia Morone, MD MS
[email protected]
617-414-6652
Jose Baez, MD
[email protected]
617-272-6848

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Boston Medical Center· Boston, MA

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