Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
ConditionChronic Low-back Pain
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 groupSponsors and collaborators
Boston Medical Center
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Worcester Polytechnic Institute
Collaborator
Source ClinicalTrials.gov