Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- IL-6 levels in knee synovial fluid change (Multiplex, cytometry)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-septic joint arthritis with power Doppler activity( score>=1/3)
排除标准
- •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
结局指标
主要结局
IL-6 levels in knee synovial fluid change (Multiplex, cytometry)
时间窗: Baseline, 24 hours
synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)
Power Doppler score change (Naredo's 0-3 semi-quantitative scale)
时间窗: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
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.
次要结局
- pain VAS change (numeric scale)(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)(Baseline, 2 minutes, 2 hours, 8 hours, 24 hours)