Pain Expectations in Subjects With Osteoarthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The purpose of this research study is to test whether or not researchers can alter or change expectations on pain. The researchers will test whether there is an effect on the size of the pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee or hip or healthy subjects for comparison. One of 3 possible treatment groups will be administered to qualifying subjects: (1) gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a medication that is commonly used to treat people with narcolepsy (a disorder that causes people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill, that is not thought to have any effect on your disease or condition

Key facts

Study ID: NCT02155257
Run by: Wake Forest University Health Sciences
People needed: 30
Starts: 2014-07-01
Expected to finish: 2017-10-01
Last updated by the study team: 2019-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Osteoarthritis of the knee or hip
Adult (ages 18-80)
Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with normal activity)
American Society of Anesthesiologists physical status 1-3
Healthy subjects without pain

You may not qualify if…

Pregnancy;
Currently taking gabapentin
Currently taking a narcotic prescription medication that is > 50 mg morphine equivalents/day
Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction
History of previous eye surgery
Psychotic disorder or a recent psychiatric hospitalization

Where it is running

Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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