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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Mindfulness meditation
  • Perspectives on pain
  • Discussion

Treatment groups

350 Participants
are divided into 1 treatment group

Locations

1
Boston Medical Center02116, BostonMassachusetts, United States

Sponsors and collaborators

Boston Medical Center

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Worcester Polytechnic Institute

Collaborator