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

Not Applicable

Recruiting

• Conditions: Lipedema; Pain

• Registration Number: NCT06898125
• Lead Sponsor: Giresun University

Brief 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.

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 Timeline

• Study Start: 2023-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dual-energy X-ray absorptiometry (DXA)	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	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 Outcome Measures

Name	Time	Method
Algometric measurements	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.
Quality of life - Nottingham Health Profile (NHP):	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.
Visual Analogue Scale (VAS)	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.

Trial Locations

Locations (1)

Giresun University Training and Research Hospital; 🇹🇷 Giresun, Turkey