Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

NCT ID: NCT05944796

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diathermy

The experimental group will receive 10 diathermy sessions.

Group Type: EXPERIMENTAL

Diathermy

Intervention Type: 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

The placebo comparator, will receive 10 placebo sessions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Camilo Jose Cela University

OTHER

Sponsor Role: lead

Responsible Party

Edurne Úbeda D'Ocasar

Doctor Edurne Úbeda D'Ocasar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Camilo José Cela

Madrid, , Spain

Countries

Spain

Other Identifiers

CamiloJcUDL

Identifier Type: -

Identifier Source: org_study_id