Effects of Compression Stockings and Kinesio Taping Method on Pain, Edema, Functional Capacity and Quality of Life in Patients With Chronic Venous Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change from Baseline Pain at 4 weeks
研究概览
简要总结
The purpose of this randomised and controlled study is to investigate the effects of Kinesio Taping method and compression stockings, combined with exercise therapy, on pain, edema, functional capacity and quality of life in patients with chronic venous disease. Therefore, the study compares effectiveness of these two methods for chronic venous disease.
详细描述
Chronic venous disease (CVD), an important cause of morbidity, is one of the most commonly reported chronic medical conditions. Venous hypertension in the lower limbs caused by venous reflux, venous obstruction or calf muscle pump failure is the main pathophysiological mechanism of CVD. The incidence of varicose veins in population varies with geographic region, age, gender and risk factors. The prevalence of trunk varicose veins has been reported 25.9% in women and 12.9% in men. Symptoms include leg pain, edema, pruritus, discomfort, trophic skin changes, venous ulcerations. Reduced quality of life, and limited activities of daily living have been reported due to the symptoms in patients with CVD.
Compression therapies play a major role in the treatment of CVD. Elastic compression stockings reduces residual volume fraction by promoting calf muscle pump function and reducing venous reflux. Periodic contractions of the gastrocnemius muscle has also beneficial impacts on improving calf muscle pump function and reducing venous stasis.
Kinesio Taping, developed by Dr. Kenzo Kase, is a taping method applied for supporting muscle function, correcting joint misalignment, improving lymph and blood flow, decreasing pain and edema. Kinesio Taping increases cutaneous and subcutaneous area by lifting the skin, thus improves movement and circulation. Mixed Kinesio Taping-compression model has been reported to improve venous symptoms, peripheral venous flow, disease severity and quality of life in patients with mild CVD.
Studies comparing conservative treatment techniques and investigating functional capacity in patients with CVD are very limited despite the high prevalence of disease. Therefore, the investigators planned this study to examine the effects of Kinesio Taping method and compression stockings on pain, edema, functional capacity and quality of lifein patients with CVD.
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
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with primary chronic venous disease after Doppler Ultrasonographic assessment by the physician
- •Presence of clinical symptoms of chronic venous disease
- •Patients with C1 (telangiectasias, reticular veins), C2 (varicose veins) or C3 (edema) clinical classes of CEAP (clinical, etiologic, anatomic, pathophysiologic) classification system
- •Patients not using medication for the treatment of chronic venous disease
- •No prior varicose vein surgery
- •Being volunteer for participating in the research
- •Signing the written informed consent form prior to participation in the study
排除标准
- •Deep Vein Thrombosis
- •Thrombophlebitis
- •Active or healed venous ulcerations
- •Hyperpigmentation
- •Bleeding varicose veins
- •Open wounds and acute infections
- •Acute decompensated heart failure
- •Uncontrolled hypertension
- •Severe cognitive impairment
- •Patients with poor adherence to the treatment program
- •Allergic reaction to polyacrylate forms of medical adhesives
- •Pregnancy
结局指标
主要结局
Change from Baseline Pain at 4 weeks
时间窗: Baseline and week 4
Intensity of pain was evaluated using the Visual Analogue Scale (VAS). VAS ranges from 0 mm indicating "no pain" to 100 mm indicating "the worst pain possible".
次要结局
- Change from Baseline Edema at 4 weeks(Baseline and week 4)
- Change From Baseline Short Form-36 at Week 4(Baseline and week 4)
- Change from Baseline Functional Capacity at 4 weeks(Baseline and week 4)
研究者
Baha Naci
Principal Investigator
Istanbul University