Overview

Pain Expectations in Subjects With Osteoarthritis

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Wake Forest University Health Sciences
Treatments:
Armodafinil
Gabapentin
Modafinil
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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