Effects of serial whole body cryotherapy on disease activity, functional health, cytokines and marker of bone and cartilage metabolism in rheumatoid diseases, e.g, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and primary fibromyalgia, and healthy individuals

Not Applicable

• Conditions: M06.80; M05.8; M45.0; L40.5; M79; Other seropositive rheumatoid arthritis; Arthropathic psoriasis; Other soft tissue disorders, not elsewhere classified

• Registration Number: DRKS00021218
• Lead Sponsor: Campus Kerckhoff der Justus-Liebig-Universität Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-01
• Study Start: 2020-04-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 192

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in reduction of pain measured on a visual analogue scale (VAS) from 0 to 100 mm before and after the intervention

Secondary Outcome Measures

Name	Time	Method
Change between baseline and after 6 GKKT applications:<br>All:<br>- Autonomy (HAQ)<br>- Functional capacity (FFbH)<br>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<br>- Disease activity of rheumatoid arthritis or psoriatic arthritis (DAS28, PASI), axSpA/AS (BASDAI), Pain syndrome (FIQ). <br>In all of them also CRP and BSG<br>- Consumption of pain medication<br>- Patient satisfaction<br>- Pro- and anti-inflammatory cytokines, central cytokines of bone metabolism<br>- Biochemical markers of cartilage and bone metabolism