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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: * 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.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
University Camilo José Cela
Madrid, Spain
Start Date
May 1, 2024
Primary Completion Date
June 1, 2024
Completion Date
August 30, 2024
Last Updated
September 19, 2024
20
ACTUAL participants
Diathermy
OTHER
Placebo
OTHER
Lead Sponsor
Camilo Jose Cela University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05739279