Reliability of Pupil Response to Acute Pain

NCT02628314 | Terminated Results

• 2 other identifiers: IRB000338911P01GM113852
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• Percentage of Change in Pupil Diameter

  pupil diameter in response to 5 second presentation of noxious heat stimuli

  8 weeks

• Pain Score on Visit 1

  Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.

  Day 1

• Pain Score on Visit 2

  Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.

  Week 2

• Pain Score on Visit 3

  Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.

  Month 1

• Pain Score on Visit 4

  Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.

  Month 2

Study Arms (1)

Osteoarthritis

Study population to include adult men and women with osteoarthritis.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with athritis in the knee or hip with moderate average daily pain score

You may qualify if:

• Adult (18-70)
• Pain from hip or knee arthritis of moderate intensity
• American Society of Anesthesiologists physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed: technical problems with pupil diameter measurement leading to unreliable data which were not analyzed.

Results Point of Contact

• Title: Dr. James C. Eisenach
• Organization: Wake Forest University School of Medicine

james.eisenach@wfusm.edu

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: December 11, 2015
• Study Start: August 4, 2015
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 31, 2026
• Results First Posted: July 31, 2026

Record last verified: 2026-04

Locations

US (1)