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