Clinical trial NCT06898125: Evaluation of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy Results in Patients With Lipedema
Official title: Evaluation of Extracorporeal Shockwave Therapy (ESWT) and Complex Decongestive Therapy (CDT) Results in Patients With Lipoedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lipedema
Pain
Keywords: lipedema
complex decongestive therapy
extracorporeal shockwave therapy
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trials
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dual-energy X-ray absorptiometry (DXA)
timeFrame: measurements will be taken before treatment and at the 2nd week after treatment.
measure: Volume measurement
timeFrame: measurements will be taken before treatment and at the 2nd week after treatment.
Secondary outcomes:
measure: Quality of life - Nottingham Health Profile (NHP):
timeFrame: measurements will be taken before treatment and at the 2nd week after treatment.
measure: Algometric measurements
timeFrame: measurements will be taken before treatment and at the 2nd week after treatment.
measure: Visual Analogue Scale (VAS)
timeFrame: measurements will be taken before treatment and at the 2nd week after treatment.
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Training and Research Hospital
Study officials:
affiliation: Giresun University
name: Mihrinur Dilvin TÜRKÖZ
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.