Evaluating muscle and skin biopsies for pain in rheumatoid arthritis patients
Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia
This study is testing if muscle and skin biopsies can help doctors better identify fibromyalgia in people with rheumatoid arthritis who have ongoing pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT06305026 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of muscle and skin biopsies in identifying fibromyalgia in patients with rheumatoid arthritis (RA) who experience chronic widespread pain. It focuses on understanding the relationship between RA and fibromyalgia, particularly how central pain mechanisms may contribute to pain experiences in these patients. By using clinical referral criteria for fibromyalgia as a reference standard, the study will evaluate the sensitivity and specificity of the biopsies in detecting fibromyalgia phenotypes. The findings could enhance the management of pain in RA patients by providing clearer diagnostic pathways.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with rheumatoid arthritis.
Not a fit: Patients with systemic autoimmune diseases other than rheumatoid arthritis or those with certain comorbidities like diabetes or neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for chronic pain in rheumatoid arthritis patients, allowing for better-targeted treatments.
How similar studies have performed: While the approach of using biopsies for fibromyalgia diagnosis is not widely tested, studies have shown that understanding central pain mechanisms can significantly impact treatment strategies for chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age equal to or over 18 * RA patient Exclusion Criteria: * Alcohol abuse * Wheelchair users, and patients who require personal assistance with daily activities. * Medication with glucocorticoids within the last 6 weeks. * A diagnosis of a systemic autoimmune disease other than RA * Peripheral vascular disease manifested by claudication or ischemic rest pain * Neuropathy * Diabetes * Patients with abnormal TSH levels.
Where this trial is running
Esbjerg
- Esbjerg Hospital — Esbjerg, Denmark (Recruiting)
Study contacts
- Study coordinator: Philip R Lage-Hansen
- Email: philip.rask.lage-hansen3@rsyd.dk
- Phone: +4530114582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.