Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Contour change in the knee.
研究概览
简要总结
Diathermy, a therapy that uses deep heat to reach deep tissue layers, is known to induce the breaking down of fatty cells and fibrotic tissue. In lipedema, patients develop fibrosis of their subcutaneous adipose tissue. Therefore, diathermy could be an interesting tool to treat this disease. To test the effectiveness of diathermy on these patients, the investigators will select women with lipedema (18 to 70 yo) and place them in two groups (experimental and control group). The experimental group will receive the treatment, that is, 10 minutes of diathermy on the medial knee surface of both knees, with an intensity that produces heat just below the participants' pain threshold. Participants from the control group will receive sham diathermy, that is, placebo. The intervention consists of 10 sessions, 3 times a week, for 4 weeks. Researchers will collect data pre and post intervention and one month after the intervention ends. Data will consist of measurements at knee level with tape and an ultrasound device, pain threshold with an algometer, a VAS score and an SF-12 questionnaire for quality of life.
详细描述
The goal of this clinical trial is to test the effectiveness of diathermy in reducing the subcutaneous adipose tissue affected by lipedema in women suffering from this disorder. The main questions it aims to answer are:
- Does diathermy produce changes in subcutaneous adipose tissue affected by lipedema?
- Is it effective as a tool for lipolysis and/or fibrolysis of said subcutaneous adipose tissue affected by lipedema?
- Do these changes result in a reduction of subcutaneous adipose tissue affected by lipedema?
- Do these changes decrease pain in the area treated with diathermy?
Participants will:
-
Be assesed prior to receiving treatment:
-
Circometry of both knees (at joint space level)
-
Pain threshold using an algometer. Area: medial below knee region, at fibular head level
-
SF-12 questionnaire
-
VAS score
-
Ultrasound mesurements at medial collateral ligament (distance from skin to ligament)
-
Receive 10 diathermy sessions. 10 minutes per knee (medial knee surface), 3 times a week for 4 weeks. Parameters: 470 KHz, capacitive head, intensity: heat below pain threshold.
-
Be assesed after receiving treatment:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 18-70 years old.
- •Diagnosed with lipedema by a medical service.
- •Patients with type III or V lipedema (involvement of legs).
- •Patients with type II lipedema are also admitted if they have a fat pad on the inner side of the knee
排除标准
- •Pacemaker or some other electronic implant
- •Metal implants or knee prostheses
- •Open wounds or burns on the inside of the knee
- •Thrombophlebitis
- •Malignant growths (cancer)
- •Infectious processes
- •Follow other non-conservative treatment related to lipedema at that time
结局指标
主要结局
Contour change in the knee.
时间窗: 30 days after finishing the treatment.
By using a tape measure, the circummetry of the knees on both sides will be assessed. The greater the contour, the more volume the patient will show.
Algometry.
时间窗: 30 days after finishing the treatment.
Using the algometer, pain sensitivity will be assessed when pressing medial infracondylar leg at the level of the fibular head. The lower the algometry score, the more pain the patient will have. The maximum value that can be reached is 5 and the minimum value is 0.
Change of adipose tissue in the knee
时间窗: 30 days after finishing the treatment.
Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
Quality of life (SF-12).
时间窗: 30 days after finishing the treatment.
SF-12 quality of life questionnaire. The higher the score obtained in the questionnaire, the better the patient's quality of life. The maximum value that can be reached is 100 and the minimum is 0.
Measure pain
时间窗: 30 days after finishing the treatment.
Visual analogic scale (VAS). The higher the visual analogue scale score, the more pain the patient presents. The maximum value that can be reached is 10 and the minimum is 0.
次要结局
- Sociodemographic variables(baseline.)
研究者
Edurne Úbeda D'Ocasar
Doctor Edurne Úbeda D'Ocasar
Camilo Jose Cela University