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NCT Number: NCT06898125

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

The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.

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Key information

Conditions

Lipedema Connective Tissue Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University Training and Research Hospital

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shockwave Therapy

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

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

Evaluation of Extracorporeal Shockwave Therapy (ESWT) and Complex Decongestive Therapy (CDT) Results in Patients With Lipoedema

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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