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Behavioural Intervention

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

N/A
Recruiting
Led By Emmanuel Agu, PhD
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
Must not have
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
Metastatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks, 4 months, 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not a patient at, nor plan to be at a participating clinic for 6+ months.
Select...
My cancer has spread to other parts of my body.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain, Enjoyment, General activity (PEG) composite score
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1510

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
402 Previous Clinical Trials
883,545 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
651,842 Total Patients Enrolled
Worcester Polytechnic InstituteOTHER
18 Previous Clinical Trials
29,639 Total Patients Enrolled
~233 spots leftby Sep 2028
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