Evaluation of Extracorporeal Shockwave Therapy (ESWT) and Complex Decongestive Therapy (CDT) Results in Patients With Lipoedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Dual-energy X-ray absorptiometry (DXA)
研究概览
简要总结
The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.
详细描述
The collected content will be transferred over SPSS 21.0. The normality distribution of the data will be evaluated with the Shapiro-Wilk Test. Data will be displayed as mean±standard deviation, median (1st quartile-3 quartile), or number(percent). In comparisons between the two consuming variables before and after exercise, if the values fit the normal distribution, the "paires sample t test" is used, if not, the Wilcoxon test is used. In the comparison of 3 groups, one-way ANOVA will be applied if it is normally distributed, and if it does not fit the normal distribution, the Kruskal Wallis test will be applied. Post-hoc analysis was planned for the printer, which was determined to determine the method statistically. To compare categorical protections is to use the Chi-square test. P < 0.05 will be considered future.
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)
盲法说明
Outcome measures were assessed by the investigator who was blinded to each patient's group. The participants and therapists were not blinded to the group allocation. Patients were briefed to not disclose which group they were in during the assessment process.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Being diagnosed with lipedema according to Wold criteria
- •Having type 1, 2 and 3 lipedema
- •Having stage 1, 2 and 3 lipedema
排除标准
- •Known rheumatic, endocrinological, neuromuscular, dermatological disease, kidney failure, liver failure and malignancy
- •Having undergone surgery for lipedema
- •Having poor circulation, open wound or infection in the lower extremities
研究组 & 干预措施
Complex Decongestive Therapy
In this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week.
干预措施: Complex Decongestive Therapy (Other)
Extracorporeal Shockwave Therapy
This group will receive therapy for two weeks, three sessions per week, with the Modus ESWT® Radial Shockwave Therapy ( İnceler Medikal, Turkey ) brand ESWT device (35mm radial wavy head); 3000 impulse 15 Hz will be applied to both lower extremities with an average energy level of 3.5.
干预措施: Extracorporeal Shockwave Therapy (Other)
Extracorporeal Shockwave Therapy and Complex Decongestive Therapy
In this group, first Extracorporeal Shockwave Therapy and then Complex Decongestive Therapy treatment will be applied in the same session for two weeks, three sessions a week.
干预措施: Extracorporeal Shockwave Therapy (Other)
Extracorporeal Shockwave Therapy and Complex Decongestive Therapy
In this group, first Extracorporeal Shockwave Therapy and then Complex Decongestive Therapy treatment will be applied in the same session for two weeks, three sessions a week.
干预措施: Complex Decongestive Therapy (Other)
结局指标
主要结局
Dual-energy X-ray absorptiometry (DXA)
时间窗: measurements will be taken before treatment and at the 2nd week after treatment.
DXA measurements were made with the patient in the supine position, with a radiation dose of 5.08 μSv, voltage 83.00 Kv, and current 0.2 mA from the head-to-heel distance by Osteosys Primus brand DXA device (Primus, X-ray densitometer, Osteosys Co. Ltd., Guro-gu, Seoul, Korea) will be made. With this measurement, the radiation dose received by the patient is very low and is below the daily natural radiation dose (7 μSv). With the obtained values, leg FM/total FM, android/gynoid fat ratios and fat mass (FM, fat mass) will be calculated using Osteosys Primus version 1.2.0 software. As a result of DXA measurements of the patients, Body Composition, Fat Mass, leg FM/total FM, Android/Gynoid FM values will be compared.
Volume measurement
时间窗: measurements will be taken before treatment and at the 2nd week after treatment.
For volume measurements in the lower extremities of the patients, circumference measurements will be taken from the ankle to the thigh at 4 cm intervals; then these values will be calculated automatically with the Pythagorean theorem in the Excel program.
次要结局
- Algometric measurements(measurements will be taken before treatment and at the 2nd week after treatment.)
- Quality of life - Nottingham Health Profile (NHP):(measurements will be taken before treatment and at the 2nd week after treatment.)
- Visual Analogue Scale (VAS)(measurements will be taken before treatment and at the 2nd week after treatment.)