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

August 24, 2025 updated by: Giresun University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Giresun, Turkey (Türkiye)
        • Giresun University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complex Decongestive Therapy
In this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week.
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.
Experimental: 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.
Other: 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.
Experimental: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measurements will be taken before treatment and at the 2nd week after treatment.
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.
measurements will be taken before treatment and at the 2nd week after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life - Nottingham Health Profile (NHP):
Time Frame: measurements will be taken before treatment and at the 2nd week after treatment.
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.
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.
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.
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.
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.
measurements will be taken before treatment and at the 2nd week after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

  • Study Director: Mihrinur Dilvin TÜRKÖZ, Giresun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.03.2023/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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