NCT02628314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

August 4, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

July 8, 2015

Last Update Submit

April 28, 2026

Conditions

PainOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Percentage of change in pupil diameter

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

    8 weeks

  • Change from Baseline Verbal Pain Scores

    Verbal pain scores will be obtained during stimulus presentation

    8 weeks

Study Arms (1)

Osteoarthritis

Study population to include adult men and women with osteoarthritis.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • James C Eisenach, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

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

April 29, 2026

Record last verified: 2026-04

Locations

US(1)