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

Camilo Jose Cela University

Status: Completed

Conditions: Lipedema

Treatments: Other: Placebo; Other: Diathermy

Study type: Interventional

Funder types: Other

Identifiers

NCT05944796

CamiloJcUDL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Diathermy

Experimental group

Description:

The experimental group will receive 10 diathermy sessions.

Treatment:

Other: Diathermy

Placebo

Placebo Comparator group

Description:

The placebo comparator, will receive 10 placebo sessions.

Treatment:

Other: Placebo