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Mindful Interoceptive Mapping for Chronic Pain

N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(3) reporting pain ≥3 on 0-10 scale with opioid medication, and
Reporting pain ≥3 on 0-10 scale with opioid medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and posttreatment, approximately 1.5 months
Awards & highlights

Study Summary

This trial is testing whether mindfulness-based interventions can help chronic pain patients who are taking opioids by reducing their pain and how much opioids they need.

Who is the study for?
This trial is for adults over 18 with chronic low back pain, who have been on opioid painkillers for more than three months and still experience moderate pain. It's not open to those with mindfulness training, cancer, recent severe substance use disorders or mental health crises, or any unstable illness that could affect treatment.Check my eligibility
What is being tested?
The study compares two types of mindfulness exercises: Mindful Interoceptive Mapping and Mindfulness of Breath. Participants will be randomly assigned to one of these methods to see how each affects their perception of pain and the amount of opioids they use.See study design
What are the potential side effects?
Mindfulness practices are generally considered safe but may sometimes lead to increased awareness of uncomfortable emotions or sensations. Rarely, individuals might experience anxiety or distress during practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience pain of 3 or more on a scale of 0-10 despite taking opioid medication.
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My pain level is 3 or higher even with opioid medication.
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I have been diagnosed with chronic low back pain.
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I have been on opioid medication for more than 3 months.
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I have been on opioid medication for more than 3 months.
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I have been diagnosed with chronic low back pain.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and posttreatment, approximately 1.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and posttreatment, approximately 1.5 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
Immediate Change in Pleasant Sensation Ratios
Longer-Term Change in Pleasant Sensation Ratios
Secondary outcome measures
Change in Opioid Medication Desire
Change in Opioid Use
Change in Pain Functional Interference
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful Interoceptive MappingExperimental Treatment1 Intervention
Group II: Mindfulness of BreathActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Interoceptive Mapping
2021
N/A
~150

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,573 Total Patients Enrolled
27 Trials studying Chronic Pain
4,384 Patients Enrolled for Chronic Pain

Frequently Asked Questions

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

What is the total number of participants for this trial?

"Affirmative. Clinicaltrials.gov details that this research project, first recorded on June 29th 2021, is currently looking for participants. Specifically, 148 individuals need to be enlisted from a single medical centre."

Answered by AI

What goals is this investigation attempting to achieve?

"The main purpose of this trial, which will span approximately 30 minutes preceding and following the final mindfulness training session, is to observe Longer-Term Change in Pleasant Sensation Ratios. Secondary objectives involve examining Single-item Numeric Rating Scale (0-10) for Pain Intensity where 0 implies no pain and 10 signifies unbearable sensation, Brief Pain Inventory for assessing Pain Functional Interference as well as a timeline follow back procedure for measuring Opioid Use."

Answered by AI

Are there any opportunities currently available to join this clinical research?

"Affirmative. Clinicaltrials.gov outlines that this research project, which was first announced on June 29th 2021, is currently accepting enrolment applications. 148 individuals are needed at a single site to complete the study."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
Adam Hanley 2021. "Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04523766.
~40 spots leftby Apr 2025
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