Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

NCT05944796 | Completed

• 1 other identifier: CamiloJcUDL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema

Keywords

Lipedema

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (1)

• Sociodemographic variables

  baseline.

Study Arms (2)

Diathermy

EXPERIMENTAL

The experimental group will receive 10 diathermy sessions.

Other: Diathermy

Placebo

PLACEBO COMPARATOR

The placebo comparator, will receive 10 placebo sessions.

Other: Placebo

Interventions

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)

Diathermy

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

University Camilo José Cela

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

Lipedema

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Edurne Úbeda D'Ocasar

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)