Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain/ache assessed using a visual analogue scale (0-10)
研究概览
简要总结
Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings
详细描述
Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary varicose veins causing pain/ache located only at the calf level
排除标准
- •Venous ulceration
- •Dermatitis
- •Superficial vein thrombosis
- •Peripheral arterial disease
- •Symptoms of non-venous origin
- •Previous use of elastic stockings
结局指标
主要结局
Pain/ache assessed using a visual analogue scale (0-10)
时间窗: One week
Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10)
次要结局
- revised Venous Clinical Severity Score (rVCSS)(One week)
- Paresthesia assessed using a visual analogue scale (0-10)(One week)
- Heaviness assessed using a visual analogue scale (0-10)(One week)
- Burning sensation assessed using a visual analogue scale (0-10)(One week)
- Ankle circumference(One week)
- Swelling sensation assessed using a visual analogue scale (0-10)(One week)
- insomnia assessed using a visual analogue scale (0-10)(One week)
- Night cramps assessed using a visual analogue scale (0-10)(One week)
- Restless legs assessed using a visual analogue scale (0-10)(One week)
- throbbing assessed using a visual analogue scale (0-10)(One week)
研究者
Stavros Kakkos
Assistant Professor of Vascular Surgery
University of Patras