Phase 4
N=30
Pain Expectations in Subjects With Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02155257 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Resting Pupil Diameter — 64; 72; 69; 66.9 mm — p=0.540
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Modafinil (Drug); Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting Pupil Diameter |
64; 72; 69; 66.9; 70.9; 66.1 | 0.540 |
| PRIMARY Pain Intensity Rating |
3.2; 2.8; 2.8 | — |
| PRIMARY Cognitive Style |
18.2; 15.5; 14.8 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02155257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.