Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Change from baseline in temperature at the fingers
研究概览
简要总结
The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.
详细描述
In a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% Rosmarinus officinalis L. (rosemary) essential oil to both hands with a wash-out period of 3 hours. Effects on vasodilatation are measured with infrared thermography. Patients' sense of warmth is assessed by the "Herdecke warmth perception questionnaire". Measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). To determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (Standardized Effect Size).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic sclerosis with skin involvement of hands and fingers
- •Raynaud phenomenon with frequent symptoms of cold hands
排除标准
- •Topical treatment with nitroglyceride
- •Lymphdrainage < 24 hours
- •Other topical treatment of hands and arms < 4 hours prior to study intervention
结局指标
主要结局
Change from baseline in temperature at the fingers
时间窗: baseline and 45 minutes after the intervention
Distal skin temperature in °C measured at the fingers with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application
次要结局
- Change from baseline in temperature at the forearms(baseline and 45 minutes after the intervention)
- Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)(baseline and 45 minutes after the intervention)
- Change from baseline in temperature at the back of the hands(baseline and 45 minutes after the intervention)
- "Scleroderma Health Assessment Questionnaire" (SHAQ)(baseline)
- Rodnan skin score of the hands(baseline)