Study Results
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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RECRUITING
80 participants
OBSERVATIONAL
2015-08-04
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
* Pain from hip or knee arthritis of moderate intensity
* American Society of Anesthesiologists physical status 1-3
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00033891
Identifier Type: -
Identifier Source: org_study_id
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