RecruitingNot ApplicableNCT06106191

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


Sponsor

Boston Medical Center

Enrollment

350 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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

Exclusion Criteria4

  • 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

Interventions

BEHAVIORALMindfulness 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.

OTHERPerspectives on pain

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

OTHERDiscussion

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


Locations(1)

Boston Medical Center

Boston, Massachusetts, United States

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NCT06106191


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