LipedemaEDRTASALNCT05944796
Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
A study testing Diathermy in people with Lipedema, run by Camilo Jose Cela University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Diathermy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Diathermy, Placebo
- Keywords
- Lipedema
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiathermyOther
The patients belonging to the experimental group will undergo 10 diathermy sessions. The control group will have the same sessions but in athermy (placebo)
PlaceboOther
The patients belonging to the placebo group will undergo 10 placebo sessions (athermya)
| Study group | Role | What they receive |
|---|---|---|
| Diathermy | Experimental | The experimental group will receive 10 diathermy sessions. Receives: Other: Diathermy |
| Placebo | Placebo comparator | The placebo comparator, will receive 10 placebo sessions. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after finishing the treatment.
Secondary outcomes (1)
Sociodemographic variables
Sociodemographic data such as age, weight, height and marital status will be collected
Measured: baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 May 2024
- Primary completion1 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edurne Úbeda D'Ocasar, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944796
- Sponsor's protocol ID
- CamiloJcUDL
- Acronym
- EDRTASAL
- Status last verified
- Sep 2024
- First submitted
- 19 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
- ClinicalTrials.gov ID
- NCT05944796
- Acronym / sponsor ID
- EDRTASAL / CamiloJcUDL
- Conditions
- Lipedema
- Keywords
- Lipedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diathermy | Experimental | Other: DiathermyThe experimental group will receive 10 diathermy sessions. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo comparator, will receive 10 placebo sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant
- Pacemaker or some other electronic implant
- Metal implants or knee prostheses
- Open wounds or burns on the inside of the knee
- Thrombophlebitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiathermyThe patients belonging to the experimental group will undergo 10 diathermy sessions. The control group will have the same sessions but in athermy (placebo) | Other | Diathermy |
| PlaceboThe patients belonging to the placebo group will undergo 10 placebo sessions (athermya) | Other | Placebo |
Primary outcome
Change of adipose tissue in the knee
Time frame: baseline
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
Time frame: after finishing the treatment (one month)
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
Time frame: 30 days after finishing the treatment.
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.
Time frame: baseline
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.
Time frame: after finishing the treatment (one month)
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.
Time frame: 30 days after finishing the treatment.
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).
Time frame: baseline
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).
Time frame: after finishing the treatment (one month)
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).
Time frame: 30 days after finishing the treatment.
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
Time frame: baseline
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
Time frame: after finishing the treatment (one month)
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
Time frame: 30 days after finishing the treatment.
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.
Time frame: baseline
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.
Time frame: after finishing the treatment (one month)
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.
Time frame: 30 days after finishing the treatment.
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.
1 secondary outcome
Sociodemographic variables
Time frame: baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diathermy in people with Lipedema, run by Camilo Jose Cela University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of adipose tissue in the knee (time frame: baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.