Evaluation of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy Results in Patients With Lipedema

NCT ID: NCT06898125

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Lipedema Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trials
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome measures were assessed by the investigator who was blinded to each patient's group. The participants and therapists were not blinded to the group allocation. Patients were briefed to not disclose which group they were in during the assessment process.

Study Groups

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Complex Decongestive Therapy

In this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week.

Group Type ACTIVE_COMPARATOR

Complex Decongestive Therapy

Intervention Type OTHER

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.

Extracorporeal Shockwave Therapy

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.

Group Type EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type OTHER

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.

Extracorporeal Shockwave Therapy and Complex Decongestive Therapy

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.

Group Type EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type OTHER

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 Therapy

Intervention Type OTHER

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.

Interventions

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Extracorporeal Shockwave Therapy

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.

Intervention Type OTHER

Complex Decongestive Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mihrinur Dilvin TÜRKÖZ

Role: STUDY_DIRECTOR

Giresun University

Locations

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Giresun University Training and Research Hospital

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33001552 (View on PubMed)

Fife 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.

Reference Type RESULT
PMID: 20087075 (View on PubMed)

Siems 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.

Reference Type RESULT
PMID: 16403988 (View on PubMed)

Brandao 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.

Reference Type RESULT
PMID: 34178058 (View on PubMed)

Other Identifiers

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13.03.2023/16

Identifier Type: -

Identifier Source: org_study_id

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