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

Primary Purpose

Lipedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diathermy
Placebo
Sponsored by
Camilo Jose Cela University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipedema focused on measuring Lipedema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Diathermy

    Placebo

    Arm Description

    The experimental group will receive 10 diathermy sessions.

    The placebo comparator, will receive 10 placebo sessions.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Camilo Jose Cela University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05944796
    Brief Title
    Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
    Acronym
    EDRTASAL
    Official Title
    Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Camilo Jose Cela University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipedema
    Keywords
    Lipedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diathermy
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive 10 diathermy sessions.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo comparator, will receive 10 placebo sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Diathermy
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Intervention Description
    The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)
    Primary Outcome Measure Information:
    Title
    Change of adipose tissue in the knee
    Description
    Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
    Time Frame
    baseline
    Title
    Change of adipose tissue in the knee
    Description
    Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
    Time Frame
    after finishing the treatment (one month)
    Title
    Change of adipose tissue in the knee
    Description
    Using ultrasound, it is intended to know if a reduction in adipose tissue has occurred after the application of diathermy.
    Time Frame
    30 days after finishing the treatment.
    Title
    Contour change in the knee.
    Description
    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.
    Time Frame
    baseline
    Title
    Contour change in the knee.
    Description
    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.
    Time Frame
    after finishing the treatment (one month)
    Title
    Contour change in the knee.
    Description
    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.
    Time Frame
    30 days after finishing the treatment.
    Title
    Quality of life (SF-12).
    Description
    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.
    Time Frame
    baseline
    Title
    Quality of life (SF-12).
    Description
    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.
    Time Frame
    after finishing the treatment (one month)
    Title
    Quality of life (SF-12).
    Description
    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.
    Time Frame
    30 days after finishing the treatment.
    Title
    Measure pain
    Description
    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.
    Time Frame
    baseline
    Title
    Measure pain
    Description
    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.
    Time Frame
    after finishing the treatment (one month)
    Title
    Measure pain
    Description
    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.
    Time Frame
    30 days after finishing the treatment.
    Title
    Algometry.
    Description
    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.
    Time Frame
    baseline
    Title
    Algometry.
    Description
    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.
    Time Frame
    after finishing the treatment (one month)
    Title
    Algometry.
    Description
    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.
    Time Frame
    30 days after finishing the treatment.
    Secondary Outcome Measure Information:
    Title
    Sociodemographic variables
    Description
    Sociodemographic data such as age, weight, height and marital status will be collected
    Time Frame
    baseline.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

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