Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Study Overview
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Brief Summary
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The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or cold gas) applications on arthritic knees. Evaluation criteria (before/after treatment): synovial power-Doppler semi-quantitative score pain VAS (mm) cytokine levels in synovial fluid leukocyte count in synovial fluid

Detailed Description
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After informed consent, patients suffering from inflammatory rheumatic diseases (rheumatoid arthritis, spondyloarthritis, crystal-induced arthritides) with non-septic arthritides were randomized to receive either local ice (30 minutes twice a day) or cold gas (2 minutes twice a day - pulsed hyperbaric CO2). Local cryotherapy was applied at 9 AM and 17 PM. Skin temperature was monitored Knee power Doppler ultrasonography was performed before cryotherapy (9 AM), just after, 2 min after, 2 hours after, before and after the second cold application (8 hours after the first cold application), then the day after at 9 A.M (24 hours after the first cold application). Synovial fluid was also analysed after join arthrocentesis (just before the first cold application, then 24 hours later, after the last ultrasonographic examination. A corticosteroid injection was performed after the second arthrocentesis when necessary. Power Doppler semi-quantitative scores (0-3) were then blindly assessed by a second trained ultrasonographist at the different times of the study. Pain VAS evolution was also monitored throughout the study. Clinical characteristics of patients were collected at baseline. 20 patients suffering from ankle/wrist arthritides were also included in order to evaluate power Doppler score evolution under cold gas or ice-cryotherapy. 15 patients suffering from knee arthritides were treated by local cold gas. 31 patients suffering from knee arthritides were treated by ice. When both knees were arthritic, contralateral synovial fluid and power Doppler score were used as non-treated controls.

Official Title
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Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Conditions
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Rheumatoid Arthritis, Crystal-induced Arthritides, Spondyloarthritis

Intervention / Treatment
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* Device: ice
* Device: cold gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-septic joint arthritis with power Doppler activity( score>=1/3) Exclusion Criteria: neurologic diseases impairing skin sensitivity cold allergia Raynaud phenomenon non-controlled diabetes mellitus, heart failure, heart pace abnormalities skin lesion on the application area cognitive impairments active vasculitis paroxystic haemoglobinuria cryoglobulin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ice<br>patients randomized to receive local ice on inflamed joint | Device: ice<br>* local ice application for 30 minutes<br>* Other names: ice pack;|
| Active Comparator: Cold gas<br>patients randomized to receive cold gas on inflamed joint | Device: cold gas<br>* local cold gas application for 2 minutes<br>* Other names: Cryo+ (pulsed hyperbaric CO2);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power Doppler score change (Naredo's 0-3 semi-quantitative scale) | Semi-quantitative power Doppler score was assessed at baseline, just after, 2 min after, 2 hours after, 8 hours after (just before the second cold application then just after), 24 hours after the first cold application. | Baseline, 2 minutes, 2 hours, 8 hours, 24 hours | 
| IL-6 levels in knee synovial fluid change (Multiplex, cytometry) | synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination) | Baseline, 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain VAS change (numeric scale) | pain VAS (mm) was recorded at each ultrasonographic examination | Baseline, 2 minutes, 2 hours, 8 hours, 24 hours | 
| synovial fluid leukocyte count change (per mm3) |  | Baseline, 24 hours | 
| IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry) |  | Baseline, 24 hours | 
| skin temperature change (°C, skin temperature probe in the application area) | Skin temperature will be measured during each ultrasonographic examination | Baseline, 2 minutes, 2 hours, 8 hours, 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryotherapy, power Doppler score, synovial fluid cytokines, pain VAS