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Completed

NCT Number: NCT05944796

Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Camilo José Cela

Madrid, 28692, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diathermy

Other

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

Other

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

Primary outcomes

  1. Change of adipose tissue in the knee

    Time frame: baseline

    Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.

  2. Change of adipose tissue in the knee

    Time frame: 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.

  3. Change of adipose tissue in the knee

    Time frame: 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.

  4. Contour change in the knee.

    Time frame: 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.

  5. Contour change in the knee.

    Time frame: 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.

  6. Contour change in the knee.

    Time frame: 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.

  7. Quality of life (SF-12).

    Time frame: 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.

  8. Quality of life (SF-12).

    Time frame: 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.

  9. Quality of life (SF-12).

    Time frame: 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.

  10. Measure pain

    Time frame: 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.

  11. Measure pain

    Time frame: 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.

  12. Measure pain

    Time frame: 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.

  13. Algometry.

    Time frame: 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.

  14. Algometry.

    Time frame: 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.

  15. Algometry.

    Time frame: 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 outcomes

  1. Sociodemographic variables

    Time frame: baseline.

    Sociodemographic data such as age, weight, height and marital status will be collected

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Acronym: EDRTASAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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