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

Study acronym: IMPACT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Aug 29, 2024, no change to tracked fieldsv7-v9
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Jul 25, 2024
    • Site details revised
    v6
  3. Start date: Jun 2024 to Jul 2024v5
  4. Start date: Apr 2024 to Jun 2024v4
  5. Start date: Mar 2024 to Apr 2024v3
  6. Start date: Dec 2023 to Mar 2024v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06106191
Lead Sponsor Boston Medical Center
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Worcester Polytechnic Institute
Conditions
(from sponsor)		 Chronic Low-back Pain
Related terms Depression, Motor Activity, Pain
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov