Reliability of Pupil Response to Acute Pain

NCT ID: NCT02628314

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Osteoarthritis

Study population to include adult men and women with osteoarthritis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James C Eisenach, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Regina Curry, RN

Role: CONTACT

336-716-4294

Facility Contacts

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Regina Curry, RN

Role: primary

336-716-4294

Other Identifiers

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IRB00033891

Identifier Type: -

Identifier Source: org_study_id

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