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Behavioural Intervention

Mindfulness-Based Therapy for Chronic Lower Back Pain (IMPACT Trial)

N/A

Waitlist Available

Led By Natalia Morone, MD MS

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks, 4 months, 6 months

Awards & highlights

IMPACT Trial Summary

This trial will use AI to identify biomarkers that can predict the response of people with chronic low back pain to Mindfulness-Based Stress Reduction, helping clinicians better treat their patients.

Who is the study for?

This trial is for English-speaking individuals who have had chronic low back pain for at least 3 months, with pain on most days in the past 6 months. Participants must be able to consent and plan to stay at a participating clinic for over 6 months. It's not suitable for those with recent severe symptoms, unexplained weight loss or fever, pregnant women, or people with metastatic cancer.Check my eligibility

What is being tested?

The study tests how well mindfulness-based stress reduction (MBSR) helps chronic low back pain by using machine learning to analyze biological, psychological, and social factors. The goal is to predict individual responses to MBSR and improve treatment decisions.See study design

What are the potential side effects?

Mindfulness meditation typically does not cause physical side effects but may bring up emotional discomfort as participants become more aware of their thoughts and feelings related to pain.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had lower back pain for at least 3 months, with pain on most days in the last 6 months.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks, 4 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks, 4 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks, 4 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain, Enjoyment, General activity (PEG) composite score

Secondary outcome measures

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

Catastrophizing assessed by the Pain Catastrophizing Scale Short Form

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

+8 more

IMPACT Trial Design

1Treatment groups

Experimental Treatment

Group I: Mindfulness based stress reduction (MBSR) programExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness meditation

2021

Completed Phase 2

~1020

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

383 Previous Clinical Trials

870,800 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,011 Total Patients Enrolled

Worcester Polytechnic InstituteOTHER

16 Previous Clinical Trials

29,529 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still in progress for this research endeavor?

"According to the clinicaltrials.gov registry, this experiment is not presently recruiting patients due to its last update on October 24th 2023. However, there are currently 335 other trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106191.

All > Lower Back Pain