RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-25
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06106191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Willing and able to provide online or telephone informed consent
  3. * Speak English as the intervention manual is currently written in English
  1. * Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
  2. * Pregnancy
  3. * Metastatic cancer
  4. * 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

Contacts and Locations

Study Contact

Natalia Morone, MD MS
CONTACT
617-414-6652
Natalia.Morone@bmc.org
Jose Baez, MD
CONTACT
617-272-6848
Jose.Baez@bmc.org

Principal Investigator

Natalia Morone, MD MS
PRINCIPAL_INVESTIGATOR
Boston Medical Center
Jean King, PhD
PRINCIPAL_INVESTIGATOR
Worcester Polytechnic Institute
Emmanuel Agu, PhD
PRINCIPAL_INVESTIGATOR
Worcester Polytechnic Institute

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02116
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Natalia Morone, MD MS, PRINCIPAL_INVESTIGATOR, Boston Medical Center
  • Jean King, PhD, PRINCIPAL_INVESTIGATOR, Worcester Polytechnic Institute
  • Emmanuel Agu, PhD, PRINCIPAL_INVESTIGATOR, Worcester Polytechnic Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-07-25
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness based stress reduction (MBSR)
  • Machine learning (ML)
  • Biopsychosocial data
  • PEG (Pain, Enjoyment, General activity)
  • Pain interference
  • Pain intensity
  • Depression

Additional Relevant MeSH Terms

  • Chronic Low-back Pain