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N/A

Neurophysiological Assessments for Chronic Pain and Opioid Risk

N/A
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Average daily pain for the past 30 days reported as ≥ 5 on a 0 - 10 scale
Unilateral pain or pain affecting predominantly one extremity. Predominantly will be operationally defined at >=75 of pain on one extremity.
Must not have
Average daily pain for the past 30 days reported as < 5 on a 0 - 10 scale
Bilateral pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year1-5
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well different neurophysiological and behavioral factors can predict pain avoidance in people with chronic pain, and whether this varies between people at different risk levels for opioid addiction.

Who is the study for?
This trial is for adults with chronic pain, rating their daily pain ≥5 out of 10 for the past month. They must have CRPS I or II, allodynia, and severe pain that hasn't improved after six months of treatment. Participants need to be willing to undergo brain scans and tests, and have mostly one-sided pain.
What is being tested?
The study uses EEG/MEG/MRI scans to understand how people with chronic pain try to avoid more pain and how this might relate to the risk of opioid addiction. It looks at behaviors, brain activity patterns, traits, and risk factors linked to avoiding pain.
What are the potential side effects?
There are generally no direct side effects from participating in this type of research which involves non-invasive brain imaging techniques like EEG/MEG/MRI; however discomfort from staying still during scanning or mild headaches may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My daily pain level has been 5 or more on a scale of 0 to 10 for the past month.
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Most of my pain is in one arm or leg.
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I experience pain from things that usually don’t cause pain.
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I have had severe pain for 6 months or more that hasn’t improved with treatment.
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I am 18 years old or older.
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I have been diagnosed with CRPS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My daily pain level has been below 5 for the last month.
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I experience pain on both sides of my body.
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I am 17 years old or younger.
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I have had severe pain for less than 6 months that medication can't control.
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I am unable to understand and agree to the study's details on my own.
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I do not experience pain from light touches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year1-5
This trial's timeline: 3 weeks for screening, Varies for treatment, and year1-5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Magnetoencephalography (MEG)/Electroencephalography (EEG)
Temperament and Character Inventory

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: PatientsExperimental Treatment1 Intervention
Patients with CRPS diagnosis
Group II: ControlsExperimental Treatment1 Intervention
Healthy controls with known Neurological Disorders

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,371,114 Total Patients Enrolled
8 Trials studying Chronic Pain
1,438 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,488 Total Patients Enrolled
64 Trials studying Chronic Pain
84,514 Patients Enrolled for Chronic Pain
Hubert Fernandez, MDStudy DirectorThe Cleveland Clinic
3 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

Pain Avoidance Behavior (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04603417 — N/A
Chronic Pain Research Study Groups: Patients, Controls
Chronic Pain Clinical Trial 2023: Pain Avoidance Behavior Highlights & Side Effects. Trial Name: NCT04603417 — N/A
Pain Avoidance Behavior (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603417 — N/A
~8 spots leftby Jul 2025
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