Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

Lipedema Clinical Trial

— EDRTASAL  

Official title:

Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05944796
• Other study ID #: CamiloJcUDL
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Camilo Jose Cela University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• 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)

• Be assesed after receiving treatment (one month post intervention):

• 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant

• 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

Related Conditions & MeSH terms

• Lipedema

Intervention

Other:
• Diathermy
The patients belonging to the experimental group will undergo 10 diathermy sessions. The control group will have the same sessions but in athermy (placebo)
• Placebo
The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Camilo Jose Cela University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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.
Primary	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
Primary	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)
Primary	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.
Primary	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.	baseline
Primary	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)
Primary	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.
Primary	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
Primary	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)
Primary	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.
Primary	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
Primary	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)
Primary	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.
Secondary	Sociodemographic variables	Sociodemographic data such as age, weight, height and marital status will be collected	baseline.