LipedemaNCT06898125
Evaluation of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy Results in Patients With Lipedema
A study testing Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in people with Lipedema and Pain, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Extracorporeal Shockwave Therapy and Complex Decongestive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jun 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18 years or older
- Being diagnosed with lipedema according to Wold criteria
- Having type 1, 2 and 3 lipedema
- Having stage 1, 2 and 3 lipedema
Who cannot join
- Known rheumatic, endocrinological, neuromuscular, dermatological disease, kidney failure, liver failure and malignancy
- Having undergone surgery for lipedema
- Having poor circulation, open wound or infection in the lower extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Training and Research Hospital
Giresun
About this study
Official title: Evaluation of Extracorporeal Shockwave Therapy (ESWT) and Complex Decongestive Therapy (CDT) Results in Patients With Lipoedema
The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.
Read the detailed description
The collected content will be transferred over SPSS 21.0. The normality distribution of the data will be evaluated with the Shapiro-Wilk Test. Data will be displayed as mean±standard deviation, median (1st quartile-3 quartile), or number(percent). In comparisons between the two consuming variables before and after exercise, if the values fit the normal distribution, the "paires sample t test" is used, if not, the Wilcoxon test is used. In the comparison of 3 groups, one-way ANOVA will be applied if it is normally distributed, and if it does not fit the normal distribution, the Kruskal Wallis test will be applied. Post-hoc analysis was planned for the printer, which was determined to determine the method statistically. To compare categorical protections is to use the Chi-square test. P < 0.05 will be considered future.
- Being tested
- Extracorporeal Shockwave Therapy, Complex Decongestive Therapy
- Keywords
- lipedema, complex decongestive therapy, extracorporeal shockwave therapy
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyOther
Shock wave therapy is a new modality for the improvement of cellulite and lipedema; it is an easy, noninvasive, local therapy, without side effects, with short periods of application. Its original idea was the stimulation of lipid mobilization and improved lipolysis in areas with edema.
Complex Decongestive TherapyOther
Complex decongestive therapy (CDT) is one of the most important treatment modalities of choice for patients with this clinical condition. CDT has two phases: treatment and maintenance. The first stage consists of skin care, manual lymph drainage, kinesiotherapy and bandaging of the limb. Drainage can facilitate the return of lymphatic flow by stimulating the cisterna chyli. Next, kinesiotherapy is applied, which aims to activate the lymph. Finally, the limb is moistened and then a compressive bandage is applied aimed at creating a pressure gradient towards the areas where lymph absorption is greater. The second phase continues skin care, physical exercises and external compression applications using bandages with varying degrees of elasticity.
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive Therapy | Active comparator | In this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week. Receives: Other: Complex Decongestive Therapy |
| Extracorporeal Shockwave Therapy | Experimental | This group will receive therapy for two weeks, three sessions per week, with the Modus ESWT® Radial Shockwave Therapy ( İnceler Medikal, Turkey ) brand ESWT device (35mm radial wavy head); 3000 impulse 15 Hz will be applied to both lower extremities with an average energy level of 3.5. Receives: Other: Extracorporeal Shockwave Therapy |
| Extracorporeal Shockwave Therapy and Complex Decongestive Therapy | Experimental | In this group, first Extracorporeal Shockwave Therapy and then Complex Decongestive Therapy treatment will be applied in the same session for two weeks, three sessions a week. Receives: Other: Extracorporeal Shockwave Therapy; Other: Complex Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-energy X-ray absorptiometry (DXA)
DXA measurements were made with the patient in the supine position, with a radiation dose of 5.08 μSv, voltage 83.00 Kv, and current 0.2 mA from the head-to-heel distance by Osteosys Primus brand DXA device (Primus, X-ray densitometer, Osteosys Co. Ltd., Guro-gu, Seoul, Korea) will be made. With this measurement, the radiation dose received by the patient is very low and is below the daily natural radiation dose (7 μSv). With the obtained values, leg FM/total FM, android/gynoid fat ratios and fat mass (FM, fat mass) will be calculated using Osteosys Primus version 1.2.0 software. As a result of DXA measurements of the patients, Body Composition, Fat Mass, leg FM/total FM, Android/Gynoid FM values will be compared.
Measured: measurements will be taken before treatment and at the 2nd week after treatment.
Volume measurement
For volume measurements in the lower extremities of the patients, circumference measurements will be taken from the ankle to the thigh at 4 cm intervals; then these values will be calculated automatically with the Pythagorean theorem in the Excel program.
Measured: measurements will be taken before treatment and at the 2nd week after treatment.
Secondary outcomes (3)
Quality of life - Nottingham Health Profile (NHP):
Nottingham Health Profile (NHP) is a general quality of life questionnaire that evaluates patients' perceptions of health problems and the effects of these problems on patients' activities of daily living. Pain, emotional reactions, sleep, social isolation, physical abilities and energy level subscales are evaluated. For each subscale, 0 points corresponds to the best health profile and 100 points corresponds to the worst health profile. The total NHP score is obtained by summing the subscale scores.
Measured: measurements will be taken before treatment and at the 2nd week after treatment.
Algometric measurements
The pain threshold of the patients will be measured from the right and left extremities with a Wagner brand manual algometer. Before the evaluation is made, the patients will be informed about how the measurement will be made, and they will be asked to give information as soon as the feeling of pressure returns to the feeling of pain. For the measurement, the compression applied by keeping the probe of the algometer device perpendicular to the measuring surface will be gradually increased at the rate of approximately 0.5kg/cm²/s. The compression applied at the point where the patients feel pain will be terminated. The measurement will be made twice in the same area and 4 minutes will be waited before the second measurement is taken. The average of the two measurements will be recorded as the pressure pain threshold.
Measured: measurements will be taken before treatment and at the 2nd week after treatment.
Visual Analogue Scale (VAS)
Pain intensity was measured with the Visual Analog Scale (0-10 mm; 0 means no pain, 10 means severe pain), which has a high reliability and validity in measuring musculoskeletal pain.
Measured: measurements will be taken before treatment and at the 2nd week after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Sep 2023
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- randomized controlled trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihrinur Dilvin TÜRKÖZ, Study director, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898125
- Sponsor's protocol ID
- 13.03.2023/16
- Status last verified
- Aug 2025
- First submitted
- 18 Mar 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12.
PubMed 33001552Fife CE, Maus EA, Carter MJ. Lipedema: a frequently misdiagnosed and misunderstood fatty deposition syndrome. Adv Skin Wound Care. 2010 Feb;23(2):81-92; quiz 93-4. doi: 10.1097/01.ASW.0000363503.92360.91.
PubMed 20087075Siems W, Grune T, Voss P, Brenke R. Anti-fibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors. 2005;24(1-4):275-82. doi: 10.1002/biof.5520240132.
PubMed 16403988Brandao ML, Soares HPDS, Andrade MDA, Faria ALSC, Pires RS. Efficacy of complex decongestive therapy for lymphedema of the lower limbs: a systematic review. J Vasc Bras. 2020 May 29;19:e20190074. doi: 10.1590/1677-5449.190074.
PubMed 34178058
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Extracorporeal Shockwave Therapy (ESWT) and Complex Decongestive Therapy (CDT) Results in Patients With Lipoedema
- ClinicalTrials.gov ID
- NCT06898125
- Acronym / sponsor ID
- 13.03.2023/16
- Keywords
- lipedema, complex decongestive therapy, extracorporeal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 27 Mar 2025 (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.
The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.
Detailed description
The collected content will be transferred over SPSS 21.0. The normality distribution of the data will be evaluated with the Shapiro-Wilk Test. Data will be displayed as mean±standard deviation, median (1st quartile-3 quartile), or number(percent). In comparisons between the two consuming variables before and after exercise, if the values fit the normal distribution, the "paires sample t test" is used, if not, the Wilcoxon test is used. In the comparison of 3 groups, one-way ANOVA will be applied if it is normally distributed, and if it does not fit the normal distribution, the Kruskal Wallis test will be applied. Post-hoc analysis was planned for the printer, which was determined to determine the method statistically. To compare categorical protections is to use the Chi-square test. P < 0.05 will be considered future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trials
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Therapy | Active comparator | Other: Complex Decongestive TherapyIn this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week. |
| Extracorporeal Shockwave Therapy | Experimental | Other: Extracorporeal Shockwave TherapyThis group will receive therapy for two weeks, three sessions per week, with the Modus ESWT® Radial Shockwave Therapy ( İnceler Medikal, Turkey ) brand ESWT device (35mm radial wavy head); 3000 impulse 15 Hz will be applied to both lower extremities with an average energy level of 3.5. |
| Extracorporeal Shockwave Therapy and Complex Decongestive Therapy | Experimental | Other: Extracorporeal Shockwave Therapy, Other: Complex Decongestive TherapyIn this group, first Extracorporeal Shockwave Therapy and then Complex Decongestive Therapy treatment will be applied in the same session for two weeks, three sessions a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- 18 years or older
- Being diagnosed with lipedema according to Wold criteria
- Having type 1, 2 and 3 lipedema
- Having stage 1, 2 and 3 lipedema
Key exclusion criteria (3 listed)
- Known rheumatic, endocrinological, neuromuscular, dermatological disease, kidney failure, liver failure and malignancy
- Having undergone surgery for lipedema
- Having poor circulation, open wound or infection in the lower extremities
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyShock wave therapy is a new modality for the improvement of cellulite and lipedema; it is an easy, noninvasive, local therapy, without side effects, with short periods of application. Its original idea was the stimulation of lipid mobilization and improved lipolysis in areas with edema. | Other | Extracorporeal Shockwave Therapy, Extracorporeal Shockwave Therapy and Complex Decongestive Therapy |
| Complex Decongestive TherapyComplex decongestive therapy (CDT) is one of the most important treatment modalities of choice for patients with this clinical condition. CDT has two phases: treatment and maintenance. The first stage consists of skin care, manual lymph drainage, kinesiotherapy and bandaging of the limb. Drainage can facilitate the return of lymphatic flow by stimulating the cisterna chyli. Next, kinesiotherapy is applied, which aims to activate the lymph. Finally, the limb is moistened and then a compressive bandage is applied aimed at creating a pressure gradient towards the areas where lymph absorption is greater. The second phase continues skin care, physical exercises and external compression applications using bandages with varying degrees of elasticity. | Other | Complex Decongestive Therapy, Extracorporeal Shockwave Therapy and Complex Decongestive Therapy |
Primary outcome
Dual-energy X-ray absorptiometry (DXA)
Time frame: measurements will be taken before treatment and at the 2nd week after treatment.
DXA measurements were made with the patient in the supine position, with a radiation dose of 5.08 μSv, voltage 83.00 Kv, and current 0.2 mA from the head-to-heel distance by Osteosys Primus brand DXA device (Primus, X-ray densitometer, Osteosys Co. Ltd., Guro-gu, Seoul, Korea) will be made. With this measurement, the radiation dose received by the patient is very low and is below the daily natural radiation dose (7 μSv). With the obtained values, leg FM/total FM, android/gynoid fat ratios and fat mass (FM, fat mass) will be calculated using Osteosys Primus version 1.2.0 software. As a result of DXA measurements of the patients, Body Composition, Fat Mass, leg FM/total FM, Android/Gynoid FM values will be compared.
Volume measurement
Time frame: measurements will be taken before treatment and at the 2nd week after treatment.
For volume measurements in the lower extremities of the patients, circumference measurements will be taken from the ankle to the thigh at 4 cm intervals; then these values will be calculated automatically with the Pythagorean theorem in the Excel program.
3 secondary outcomes
Quality of life - Nottingham Health Profile (NHP):
Time frame: measurements will be taken before treatment and at the 2nd week after treatment.
Algometric measurements
Time frame: measurements will be taken before treatment and at the 2nd week after treatment.
Visual Analogue Scale (VAS)
Time frame: measurements will be taken before treatment and at the 2nd week after treatment.
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 26 Aug 2025.
- Results publication: PubMed 33001552Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12.
- Results publication: PubMed 20087075Fife CE, Maus EA, Carter MJ. Lipedema: a frequently misdiagnosed and misunderstood fatty deposition syndrome. Adv Skin Wound Care. 2010 Feb;23(2):81-92; quiz 93-4. doi: 10.1097/01.ASW.0000363503.92360.91.
- Results publication: PubMed 16403988Siems W, Grune T, Voss P, Brenke R. Anti-fibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors. 2005;24(1-4):275-82. doi: 10.1002/biof.5520240132.
- Results publication: PubMed 34178058Brandao ML, Soares HPDS, Andrade MDA, Faria ALSC, Pires RS. Efficacy of complex decongestive therapy for lymphedema of the lower limbs: a systematic review. J Vasc Bras. 2020 May 29;19:e20190074. doi: 10.1590/1677-5449.190074.
- 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.
Mihrinur Dilvin TÜRKÖZ study director
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in people with Lipedema and Pain, run by Giresun University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 26 Aug 2025. 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 Turkey (Türkiye). 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. 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?
Dual-energy X-ray absorptiometry (DXA) (time frame: measurements will be taken before treatment and at the 2nd week after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898125, which also lists 4 linked publications.
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 26 Aug 2025.