Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING
- Conditions
- Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade.MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisMedDRA version: 9.1Level: LLTClassification code 10060016Term: Alpha tumor necrosis factorMedDRA version: 9.1Level: LLTClassification code 10029817Term: Nuclear magnetic resonance imaging brainMedDRA version: 9.1Level: LLTClassification code 10053689Term: Cardiovascular autonomic function test
- Registration Number
- EUCTR2008-005212-40-SE
- Lead Sponsor
- Karolinska Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Rheumatoid arthritis: Only female patients will be included, this is because it is needed to minimize inter-individual differences in pain perception, known to be significantly dependent on gender (Soetano et al. Are there gender differences in pain perception? J Neurosci Nurse 2006;38:172-176; Garcia et al. Gender differences in pressure pain threshold in a repeated measures assessment. Psychol Health Med 2007;12:567-579). Age 20-50. Fulfilling ACR criteria for RA. The responsible Rheumatologist have found need for antirheumatic treatment with Remicade.
Healthy controls: Females. Age 20-50.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
RA: Males (se explanation under E.3). Fulfilling ACR criteria for fibromyalgia. left-handness (for fMRI). Significant heart disease. Current treatment with antidepressive drugs. Contraindications for Remicade.
Healthy controls: Males. Fulfilling ACR criteria for RA or fibromyalgia. Recurrent pain problems (>40 mm on VAS scale for pain). Left-handness (for fMRI). Significant heart disease. Current treatment with antidepressive drugs. Neurological disease. Diabetes Mellitus.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method