- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02628314
Reliability of Pupil Response to Acute Pain
Study Overview
Status
Conditions
Detailed Description
There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study.
Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks.
Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Regina Curry, RN
- Phone Number: 336-716-4294
- Email: RECURRY@WAKEHEALTH.EDU
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Medical Center
-
Principal Investigator:
- James C Eisenach, MD
-
Contact:
- Regina Curry, RN
- Phone Number: 336-716-4294
- Email: RECURRY@WAKEHEALTH.EDU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (18-70)
- Pain from hip or knee arthritis of moderate intensity
- American Society of Anesthesiologists physical status 1-3
Exclusion Criteria:
- Inability to complete study questionnaires
- Pregnancy
- Litigation or workers compensation related to hip or knee pain
- Taking > 50 mg morphine equivalents/day
- History of Raynaud's disease of the feet
- Psychotic disorder or a recent psychiatric hospitalization
- History of eye surgery or topical eye medications that would would directly affect pupil diameter
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Osteoarthritis
Study population to include adult men and women with osteoarthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of change in pupil diameter
Time Frame: 8 weeks
|
pupil diameter in response to 5 second presentation of noxious heat stimuli
|
8 weeks
|
Change from Baseline Verbal Pain Scores
Time Frame: 8 weeks
|
Verbal pain scores will be obtained during stimulus presentation
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: James C Eisenach, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00033891
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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