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

NCT06898125 | Completed DMC

• 1 other identifier: 13.03.2023/16
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Pain

Keywords

lipedema; complex decongestive therapy; extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (2)

• Dual-energy X-ray absorptiometry (DXA)

  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

  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 Outcomes (3)

• Quality of life - Nottingham Health Profile (NHP):

  measurements will be taken before treatment and at the 2nd week after treatment.

• Algometric measurements

  measurements will be taken before treatment and at the 2nd week after treatment.

• Visual Analogue Scale (VAS)

  measurements will be taken before treatment and at the 2nd week after treatment.

Study Arms (3)

Complex Decongestive Therapy

ACTIVE COMPARATOR

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

Extracorporeal Shockwave Therapy

EXPERIMENTAL

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

Extracorporeal Shockwave Therapy and Complex Decongestive Therapy

EXPERIMENTAL

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: Extracorporeal Shockwave Therapy; Other: Complex Decongestive Therapy

Interventions

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.

Extracorporeal Shockwave Therapy; Extracorporeal Shockwave Therapy and Complex Decongestive Therapy

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.

Complex Decongestive Therapy; Extracorporeal Shockwave Therapy and Complex Decongestive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University Training and Research Hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 33001552 RESULT

• 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.

  PMID: 20087075 RESULT

• 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.

  PMID: 16403988 RESULT

• 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.

  PMID: 34178058 RESULT

MeSH Terms

Conditions

Lipedema; Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mihrinur Dilvin TÜRKÖZ

  Giresun University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trials

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: September 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)