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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
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease
Pain Osteoarthritis

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort
Osteoarthritis
Study population to include adult men and women with osteoarthritis.



Primary Outcome Measures :
  1. Percentage of change in pupil diameter [ Time Frame: 8 weeks ]
    pupil diameter in response to 5 second presentation of noxious heat stimuli

  2. Change from Baseline Verbal Pain Scores [ Time Frame: 8 weeks ]
    Verbal pain scores will be obtained during stimulus presentation


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with athritis in the knee or hip with moderate average daily pain score
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Regina Curry, RN 336-716-4294 recurry@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Regina Curry, RN    336-716-4294    recurry@wakehealth.edu   
Principal Investigator: James C Eisenach, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: James C Eisenach, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02628314    
Other Study ID Numbers: IRB00033891
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations