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Neurophysiological Assessments for Chronic Pain and Opioid Risk
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Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year1-5
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am 18 years old or older.
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I have been diagnosed with CRPS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year1-5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year1-5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnetoencephalography (MEG)/Electroencephalography (EEG)
Temperament and Character Inventory
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
1,030 Previous Clinical Trials
1,365,498 Total Patients Enrolled
8 Trials studying Chronic Pain
1,438 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,671 Total Patients Enrolled
55 Trials studying Chronic Pain
82,900 Patients Enrolled for Chronic Pain
Hubert Fernandez, MDStudy DirectorThe Cleveland Clinic
3 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a condition that causes pain.My daily pain level has been below 5 for the last month.You can have a brain MRI scan.I experience pain on both sides of my body.My daily pain level has been 5 or more on a scale of 0 to 10 for the past month.Most of my pain is in one arm or leg.I experience pain from things that usually don’t cause pain.You are afraid of small spaces or cannot have an MRI because of certain medical devices in your body.I have had severe pain for 6 months or more that hasn’t improved with treatment.I am 17 years old or younger.I have had severe pain for less than 6 months that medication can't control.I am unable to understand and agree to the study's details on my own.I do not experience pain from light touches.I am 18 years old or older.I have been diagnosed with CRPS.
Research Study Groups:
This trial has the following groups:- Group 1: Patients
- Group 2: Controls
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left to join this research initiative?
"Affirmative. Clinicaltrials.gov contains evidence that points to this medical trial still recruiting individuals, with the original posting on August 15th 2020 and most recent update being July 20th 2022. The investigation requires 60 participants from a single site."
Answered by AI
How many individuals have been included in this clinical investigation?
"Yes, according to data hosted on clinicaltrials.gov, the trial was unveiled on August 15th 2020 and is currently seeking participants. The study aims to recruit 60 patients from a single research centre."
Answered by AI
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