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

NCT06106191 | Recruiting

• 2 other identifiers: H-44407UG3NS135168
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain, Enjoyment, General activity (PEG) composite score

  The PEG is a 3-question scale: "pain average", "interference with general activity" and "interference with enjoyment of life". Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and \<12=Mild,12 to \<21 = Moderate, 21 to 30 = Severe chronic pain.

  6 months

Secondary Outcomes (11)

• Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Catastrophizing assessed by the Pain Catastrophizing Scale Short Form

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29)

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

Study Arms (1)

Mindfulness based stress reduction (MBSR) program

EXPERIMENTAL

Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.

Behavioral: Mindfulness meditation; Other: Perspectives on pain; Other: Discussion

Interventions

Mindfulness meditation BEHAVIORAL

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.

Mindfulness based stress reduction (MBSR) program

Perspectives on pain OTHER

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

Mindfulness based stress reduction (MBSR) program

Discussion OTHER

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

Mindfulness based stress reduction (MBSR) program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Worcester Polytechnic Institute: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02116, United States

RECRUITING

MeSH Terms

Conditions

Pain; Motor Activity; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natalia Morone, MD MS

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Jean King, PhD

  Worcester Polytechnic Institute

  PRINCIPAL INVESTIGATOR

• Emmanuel Agu, PhD

  Worcester Polytechnic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Morone, MD MS

CONTACT

617-414-6652; Natalia.Morone@bmc.org

Jose Baez, MD

CONTACT

617-272-6848; Jose.Baez@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: July 25, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)