NCT05944796

Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Camilo Jose Cela University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lipedema

Interventions

Type	Name	Description
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)
OTHER	Placebo	The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-01
• Completion: 2024-08-30
• First posted: 2023-07-13
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain