Mindfulness-based treatment for chronic low back pain
Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
This study is testing how well an 8-week mindfulness program helps people with chronic low back pain and what factors might affect their results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06106191 on ClinicalTrials.gov |
What this trial studies
This study aims to identify unique biological, psychological, and social markers that influence the response of individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction (MBSR) using machine learning techniques. Over a 24-month period, researchers will collect comprehensive biopsychosocial data from participants to develop predictive models for treatment response. The study will involve a single-arm clinical trial with 300 participants undergoing an 8-week MBSR program conducted via Zoom, with assessments at multiple time points to evaluate pain and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing chronic low back pain for at least three months who are willing to participate in an online intervention.
Not a fit: Patients with recent worsening pain, pregnancy, metastatic cancer, or those not planning to remain patients at a participating clinic may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatments for patients suffering from chronic low back pain.
How similar studies have performed: Other studies have shown promise in using mindfulness-based approaches for pain management, but this specific predictive modeling approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Natalia Morone, MD MS — Boston Medical Center
- Study coordinator: Natalia Morone, MD MS
- Email: Natalia.Morone@bmc.org
- Phone: 617-414-6652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.