EDRTASAL: Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

Sponsor

Camilo Jose Cela University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05944796

Collaborator

(none)

Enrollment

Arms

1.3

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lipedema	Other: Diathermy Other: Placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diathermy The experimental group will receive 10 diathermy sessions.	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 Comparator: Placebo The placebo comparator, will receive 10 placebo sessions.	Other: Placebo The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)

Arm

Intervention/Treatment

Experimental: Diathermy

The experimental group will receive 10 diathermy sessions.

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 Comparator: Placebo

The placebo comparator, will receive 10 placebo sessions.

Other: Placebo

The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)

Outcome Measures

Primary Outcome Measures

Change of adipose tissue in the knee [baseline]
Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
Change of adipose tissue in the knee [after finishing the treatment (one month)]
Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
Change of adipose tissue in the knee [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.
Contour change in the knee. [baseline]
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.
Contour change in the knee. [after finishing the treatment (one month)]
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.
Contour change in the knee. [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.
Quality of life (SF-12). [baseline]
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.
Quality of life (SF-12). [after finishing the treatment (one month)]
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.
Quality of life (SF-12). [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 [baseline]
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.
Measure pain [after finishing the treatment (one month)]
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.
Measure pain [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.
Algometry. [baseline]
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.
Algometry. [after finishing the treatment (one month)]
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.
Algometry. [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.

Secondary Outcome Measures

Sociodemographic variables [baseline.]
Sociodemographic data such as age, weight, height and marital status will be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Camilo Jose Cela University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Edurne Úbeda D'Ocasar, Doctor Edurne Úbeda D'Ocasar, Camilo Jose Cela University

ClinicalTrials.gov Identifier:

NCT05944796

Other Study ID Numbers:

CamiloJcUDL

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Edurne Úbeda D'Ocasar, Doctor Edurne Úbeda D'Ocasar, Camilo Jose Cela University

Lipedema

Additional relevant MeSH terms:

Lipedema

Study Results

No Results Posted as of Jul 13, 2023