Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema (EDRTASAL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lipedema
• Intervention / Treatment: Other: Diathermy; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	Sociodemographic data such as age, weight, height and marital status will be collected	baseline.

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lipedema
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: CamiloJcUDL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No