Reliability of Pupil Response to Acute Pain
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|ClinicalTrials.gov Identifier: NCT02628314|
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : October 30, 2020
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Reliability of Pupil Response to Acute Pain|
|Actual Study Start Date :||August 4, 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Study population to include adult men and women with osteoarthritis.
- Percentage of change in pupil diameter [ Time Frame: 8 weeks ]pupil diameter in response to 5 second presentation of noxious heat stimuli
- Change from Baseline Verbal Pain Scores [ Time Frame: 8 weeks ]Verbal pain scores will be obtained during stimulus presentation
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628314
|Contact: Regina Curry, RNemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Medical Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Regina Curry, RN 336-716-4294 firstname.lastname@example.org|
|Principal Investigator: James C Eisenach, MD|
|Principal Investigator:||James C Eisenach, MD||Wake Forest University Health Sciences|