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NCT02628314 Clinical Trial

Reliability of Pupil Response to Acute Pain

Pain Clinical Trial

Official title:
Reliability of Pupil Response to Acute Pain

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02628314
Other study ID # IRB00033891
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2015
Est. completion date December 2024

Study information
Verified date July 2023
Source Wake Forest University Health Sciences
Contact Regina Curry, RN
Phone 336-716-4294
Email recurry@wakehealth.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of change in pupil diameter pupil diameter in response to 5 second presentation of noxious heat stimuli 8 weeks
Primary Change from Baseline Verbal Pain Scores Verbal pain scores will be obtained during stimulus presentation 8 weeks
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