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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.
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:
Participants will:
Be assesed prior to receiving treatment:
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:
Be assesed after receiving treatment (one month post intervention):
Researchers will compare an experimental group to a placebo group to see if treatment with diathermy is effective in reducing subcutaneous adipose tissue affected by lipedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diathermy | Experimental | The experimental group will receive 10 diathermy sessions. |
|
| Placebo | Placebo Comparator | The placebo comparator, will receive 10 placebo sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diathermy | Other | The patients belonging to the experimental group will undergo 10 diathermy sessions. The control group will have the same sessions but in athermy (placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of adipose tissue in the knee | Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy. | baseline |
| Change of adipose tissue in the knee | Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy. | after finishing the treatment (one month) |
| Change of adipose tissue in the knee | Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy. | 30 days after finishing the treatment. |
| Contour change in the knee. | 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. | baseline |
| Contour change in the knee. | 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. | after finishing the treatment (one month) |
| Contour change in the knee. | 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. | 30 days after finishing the treatment. |
| Quality of life (SF-12). |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic variables | Sociodemographic data such as age, weight, height and marital status will be collected | baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Camilo José Cela | Madrid | 28692 | Spain |
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Placebo | Other | The patients belonging to the placebo group will undergo 10 placebo sessions (athermya) |
|
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.
| baseline |
| Quality of life (SF-12). | 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. | after finishing the treatment (one month) |
| Quality of life (SF-12). | 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. | 30 days after finishing the treatment. |
| Measure pain | 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. | baseline |
| Measure pain | 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. | after finishing the treatment (one month) |
| Measure pain | 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. | 30 days after finishing the treatment. |
| Algometry. | 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. | baseline |
| Algometry. | 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. | after finishing the treatment (one month) |
| Algometry. | 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. | 30 days after finishing the treatment. |