M06.80 M05.8 M45.0 L40.5 M79
Conditions
Interventions
Group 1: Study arm 1: Patients with rheumatoid arthritis (seropositive and seronegative) who meet the 2010 ACR/EULAR classification criteria for rheumatoid arthritis
Arm 1.1: Serial (6 applications w
Sponsors
Campus Kerckhoff der Justus-Liebig-Universität Gießen
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - confirmed rheumatoid arthritis according to the ACR/EULAR classification criteria of rheumatoid arthritis of 2010 - confirmed psoriatic arthritis according to the CASPAR criteria - confirmed axial spondylarthritis / ankylosing arthritis according to the ASAS classification criteria - confirmed primary fibromyalgia according to the ACR/EULAR criteria of 2010 and the modification of 2011 - Health control subjects after medical examination - Written consent and approval of the study - stable medication (antirheumatic as well as analgesic and other basic medication) 4 weeks before starting the study and during the entire study
Exclusion criteria
Exclusion criteria: Contraindications for whole-body cold therapy treatment (cryoglobulins, cold urticaria, vasculitis, Raynaud's syndrome, unstable arterial hypertension, peripheral arterial circulatory disorders, cold hypersensitivity, disturbed temperature sensation, bladder and kidney diseases, etc.) . No written consent. No comprehension of the study. Lack of German knowledge. Presence of an accompanying secondary pain syndrome in patients with inflammatory rheumatic diseases (RA, PsA, axSpA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in reduction of pain measured on a visual analogue scale (VAS) from 0 to 100 mm before and after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Change between baseline and after 6 GKKT applications: All: - Autonomy (HAQ) - Functional capacity (FFbH) Parameters in addition for the axSpA/AS collective: Ott test, Schober test, finger-floor distance, lateral flexion and rotation of the spine, Flèche, AUD, BASFI - Disease activity of rheumatoid arthritis or psoriatic arthritis (DAS28, PASI), axSpA/AS (BASDAI), Pain syndrome (FIQ). In all of them also CRP and BSG - Consumption of pain medication - Patient satisfaction - Pro- and anti-inflammatory cytokines, central cytokines of bone metabolism - Biochemical markers of cartilage and bone metabolism | — |
Countries
Germany
Contacts
Public ContactUwe Lange
Campus Kerckhoff der Justus-Liebig-Universität Gießen, Abt. für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
Outcome results
None listed