ESWT for Primary Lipedema

NCT07240415 | Not Yet Recruiting

• 1 other identifier: sba150585
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled clinical trial aims to evaluate the effectiveness of extracorporeal shockwave therapy (ESWT) when added to standard conservative treatment in women with primary lipedema. Participants will be randomly assigned to receive either standard conservative therapy alone or standard therapy combined with radial ESWT. The study will assess changes in pain intensity (VAS), limb circumference measurements, quality of life (SF-36), and patient satisfaction over an 8-week period. Evaluations will be performed at baseline, at the end of the 4-week treatment phase, and at 4-week follow-up. This trial seeks to provide evidence on whether ESWT offers additional clinical benefit in the management of primary lipedema.

Conditions

Lipedema

Keywords

Lipedema; Extracorporeal Shockwave Therapy; ESWT; Radial Shockwave; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Limb Circumference Measurements

  Circumference will be measured at the thigh (+10 cm and +20 cm above the patella), calf (10 cm above the medial malleolus), and ankle (narrowest point). The change from baseline will be compared at Week 4 and Week 8.

  Baseline (T0), Week 4 (T1), Week 8 (T2)

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• Short Form-36 Health Survey (SF-36)

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• Treatment Satisfaction (Likert Scale)

  Week 4 (T1), Week 8 (T2)

Study Arms (2)

Standard Conservative Therapy

ACTIVE COMPARATOR

Participants receive standard conservative treatment including manual lymphatic drainage, pneumatic compression, Class II compression garments, and a home-based exercise program.

Other: Standard Conservative Therapy

Standard Therapy plus ESWT

EXPERIMENTAL

Participants receive standard conservative treatment plus radial extracorporeal shockwave therapy (ESWT) applied twice weekly for 4 weeks (8 sessions) to the thighs and calves.

Other: Standard Conservative Therapy; Device: radial ESWT

Interventions

Standard Conservative Therapy OTHER

Manual lymphatic drainage, pneumatic compression, Class II compression garments, and a home-based exercise program.

Standard Conservative Therapy; Standard Therapy plus ESWT

radial ESWT DEVICE

adial extracorporeal shockwave therapy using a BTL device (2.0-2.5 bar, 12 Hz, 1000 shocks per region, 20-mm head), twice weekly for 4 weeks (8 sessions).

Standard Therapy plus ESWT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Eligibility is limited to biological females because primary lipedema occurs almost exclusively in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-65 years Diagnosis of primary lipedema (Stage I-II according to Wold criteria) Stable body weight for the past 3 months Ability to comply with compression garment use Willingness to participate and ability to provide informed consent

You may not qualify if:

• Secondary lipedema or severe venous disease (CEAP C4 or higher) Liposuction or similar procedures within the past 6 months Pregnancy or breastfeeding Active infection, inflammation, or thrombosis Use of high-dose anticoagulants Contraindications to extracorporeal shockwave therapy

Sponsors & Collaborators

• Fatih Bagcier: lead

Related Publications (3)

• Knobloch K, Kraemer R. Extracorporeal shock wave therapy (ESWT) for the treatment of cellulite--A current metaanalysis. Int J Surg. 2015 Dec;24(Pt B):210-7. doi: 10.1016/j.ijsu.2015.07.644. Epub 2015 Jul 22.

  PMID: 26209782 RESULT

• Knobloch K, Joest B, Kramer R, Vogt PM. Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial. Dermatol Ther (Heidelb). 2013 Dec;3(2):143-55. doi: 10.1007/s13555-013-0039-5. Epub 2013 Dec 3.

  PMID: 24297647 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

MeSH Terms

Conditions

Lipedema; Chronic Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fatih bağcıer, MD

CONTACT

+905442429042; bagcier_42@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments, including VAS, SF-36, and circumference measurements, will be performed by an evaluator who is blinded to group allocation. Participants and treatment providers will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into two parallel groups receiving either standard conservative therapy alone or standard therapy plus radial ESWT. Outcome assessments will be performed by a blinded evaluator.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share