NCT06106191 Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
| NCT ID | NCT06106191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2024-07-25 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Natalia Morone, MD MS
PRINCIPAL INVESTIGATOR
Boston Medical Center
Frequently Asked Questions
Who can join the NCT06106191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06106191 currently recruiting?
Yes, NCT06106191 is actively recruiting participants. Contact the research team at Natalia.Morone@bmc.org for enrollment information.
Where is the NCT06106191 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06106191 clinical trial?
NCT06106191 is sponsored by Boston Medical Center. The principal investigator is Natalia Morone, MD MS at Boston Medical Center. The trial plans to enroll 350 participants.