Clinical trial NCT05944796: Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
Official title: Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Keywords: Lipedema
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of adipose tissue in the knee
timeFrame: baseline
measure: Change of adipose tissue in the knee
timeFrame: after finishing the treatment (one month)
measure: Change of adipose tissue in the knee
timeFrame: 30 days after finishing the treatment.
measure: Contour change in the knee.
timeFrame: baseline
measure: Contour change in the knee.
timeFrame: after finishing the treatment (one month)
measure: Contour change in the knee.
timeFrame: 30 days after finishing the treatment.
measure: Quality of life (SF-12).
timeFrame: baseline
measure: Quality of life (SF-12).
timeFrame: after finishing the treatment (one month)
measure: Quality of life (SF-12).
timeFrame: 30 days after finishing the treatment.
measure: Measure pain
timeFrame: baseline
measure: Measure pain
timeFrame: after finishing the treatment (one month)
measure: Measure pain
timeFrame: 30 days after finishing the treatment.
measure: Algometry.
timeFrame: baseline
measure: Algometry.
timeFrame: after finishing the treatment (one month)
measure: Algometry.
timeFrame: 30 days after finishing the treatment.
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: baseline.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Camilo José Cela
Study officials:
References: