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Behavioral Intervention
MBSR for Chronic Pain
N/A
Recruiting
Led By Todd Favorite, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any form of self-reported chronic pain (except cancer related pain)
A form of chronic pain disorder other than chronic lower back pain (cLBP) - examples include chronic pain associated with rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, etc.
Must not have
Unable to speak and write English
Visual or hearing difficulties that would preclude participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment), 8 and 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at how well MBSR works for people with chronic pain. They think that some people might respond better to MBSR than others, and they want to find out why.
Who is the study for?
This trial is for adults over 18 with various chronic pain disorders, excluding lower back pain linked to specific conditions. Participants should have experienced pain for at least six months and on most days, with significant daily life interference due to pain. Those with cancer-related pain or sensory impairments that would hinder participation are not eligible.
What is being tested?
The study aims to understand how Mindfulness-based Stress Reduction (MBSR) helps manage chronic pain symptoms in different individuals. It will explore if light phenotyping can predict who benefits most from MBSR by identifying varying underlying mechanisms of their chronic pain.
What are the potential side effects?
Since MBSR involves mindfulness practices like meditation, it's generally considered safe with minimal side effects. Some may experience temporary discomfort or emotional distress when learning new ways to deal with their chronic pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience chronic pain that is not caused by my cancer.
Select...
I have a chronic pain condition that is not lower back pain.
Select...
I have had pain for at least six months, and it's present most days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot speak or write in English.
Select...
I do not have severe visual or hearing problems.
Select...
I experience chronic pain due to my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-treatment), 8 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment), 8 and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PROMIS physical function 6b
Secondary study objectives
Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8
Anxiety
Change in Pain Catastrophizing Scale (PCS)
+1 moreAwards & 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: MBSR treatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,854 Previous Clinical Trials
6,433,261 Total Patients Enrolled
Todd Favorite, Ph.D.Principal Investigator - University of Michigan
Regents of the University of Michigan, University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, Von Voigtlander Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a pain interference score of 60 or higher on the PROMIS Pain Interference scale.I experience chronic pain that is not caused by my cancer.I cannot speak or write in English.I do not have severe visual or hearing problems.I experience chronic pain due to my cancer.I have a chronic pain condition that is not lower back pain.I have had pain for at least six months, and it's present most days.My chronic lower back pain is not due to sacroiliitis or spondyloarthropathy.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: MBSR treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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