Status:
UNKNOWN
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
Research Foundation Flanders
Universiteit Antwerpen
Conditions:
Fatigue Syndrome, Chronic
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Both patients with peripheral structural pathologies, like rheumatoid arthritis (RA)-patients, or patients with central sensitivity syndromes (CSS) suffer chronic pain. CSS are characterized by an inc...
Eligibility Criteria
Inclusion
- Each study participant should be aged between 18 and 65 years. All three groups will be comparable for age, gender, education level and socioeconomic status; both patient groups will be comparable for illness duration.
- The Central Sensitivity Syndrome (CSS) group will comply with the diagnostic criteria for Fibromyalgia (FM) as defined by the American College of Rheumatology and the Centre of Disease Control criteria for Chronic Fatigue Syndrome (CFS).
- At the time of study participation, healthy control subjects cannot suffer any pain complaints. Sedentary is defined as a sedentary job and \< 3 h moderate physical activity/week. Moderate physical activity is defined as activity demanding at least the threefold of the energy spent passively.
- Patients have to be able to cycle on a bicycle ergometer.
Exclusion
- In order to preclude confounding factors, participants cannot be pregnant (pregnancy test) or until 1 year postnatal and will be asked to stop medication two weeks prior to study participation, not to undertake physical exertion, and to refrain from consuming caffeine, alcohol or nicotine on the day of the experiment. For ethical reasons, Rheumatoid arthritis(RA)-patients are able to take non-opioid pain medication as described in the 1st step of the World Health Organization analgesic ladder (Non-Steroidal Anti-Inflammatory Drugs and paracetamol).
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01154647
Start Date
September 1 2010
Last Update
July 1 2010
Active Locations (1)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650