Osteoarthritis
Conditions
Keywords
fMRI functional magnetic resonance imaging Pain
Brief summary
The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.
Interventions
DRUGNaproxen
500 mg BID 7 days
DRUGPlacebo
BID 7 days
Sponsors
King's College London
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Right-handed, post-menopausal female, any race, 50-80 years * Clinical diagnosis of osteoarthritis of the hand * Estimated pain in this joint of at least 5 on a scale of 0 to 10
Exclusion criteria
* Any patient who smokes more than 5 cigarettes per day * Patients receiving some anti-depressant drugs unless the dose is stable * Patients unable to be admitted or lie still in an MRI scanner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest. | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| Whole brain resting-state distribution of Cerebral Blood Flow | 22 days |
| Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity | 22 days |
| Pain induced by a grip task measured with a Visual Analogue Scale (VAS), the Short-Form McGill Pain Questionnaire and patient-rated wrist/hand evaluation (PRWHE) | 22 days |
Countries
United Kingdom
Outcome results
None listed