ESWT for Primary Lipedema

NCT ID: NCT07240415

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-08-01

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.

Detailed Description

Lipedema is a chronic, progressive adipose tissue disorder characterized by disproportionate subcutaneous fat accumulation, pain, tenderness, easy bruising, and functional limitations. It predominantly affects women and leads to impaired mobility and reduced quality of life. Current international guidelines recommend conservative therapies as first-line management, including manual lymphatic drainage, pneumatic compression, compression garments, targeted exercise programs, and patient education. Although these interventions improve pain and function, their impact on underlying fibrotic changes and tissue stiffness is limited, creating a need for adjunctive treatments.

Extracorporeal shockwave therapy (ESWT) has been shown to enhance microcirculation, modulate inflammation, improve lymphatic flow, and exert anti-fibrotic effects through mechanotransduction. Positive outcomes have been reported in conditions with similar tissue characteristics, such as cellulite, lymphedema, and post-liposuction fibrosis. However, no randomized controlled trials have evaluated the efficacy of ESWT specifically in primary lipedema. This trial aims to address this gap in the literature.

This prospective, randomized, evaluator-blinded, controlled clinical study will include adult women aged 18-65 years diagnosed with Stage I-II primary lipedema according to Wold criteria. Eligible participants will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Medical Point Gaziantep Hospital. Participants will be randomized in a 1:1 ratio into two groups: (1) standard conservative therapy alone, or (2) standard conservative therapy plus radial ESWT. Conservative treatment will include manual lymphatic drainage, pneumatic compression therapy, Class II compression garments, and a home-based exercise program.

The ESWT group will receive additional radial ESWT using a BTL device with the following parameters: 2.0-2.5 bar pressure, 12 Hz frequency, 1000 shocks per region, 20-mm radial applicator head. Treatment regions will include the anterolateral thigh, medial thigh, and posterolateral calf. ESWT will be administered twice weekly for 4 weeks, totaling 8 sessions. Limb circumference will be measured at predefined anatomical points (thigh +10 cm/+20 cm above the patella, calf 10 cm above the medial malleolus, and ankle at the narrowest point).

Outcome measures will include pain intensity (VAS), quality of life (SF-36), limb circumference measurements, and patient satisfaction. Assessments will be performed at baseline (T0), immediately after completion of the 4-week intervention period (T1), and 4 weeks post-treatment (T2). The primary outcome is the change in VAS pain score from baseline to week 4. Secondary outcomes include changes in limb circumference, SF-36 scores, and satisfaction ratings, as well as the monitoring of any adverse events.

The study aims to determine whether adding ESWT to standard conservative management results in superior clinical outcomes compared with standard therapy alone. Findings may contribute to the development of evidence-based therapeutic strategies for women with primary lipedema.

Conditions

Lipedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Therapy plus ESWT

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

Group Type: EXPERIMENTAL

Standard Conservative Therapy

Intervention Type: OTHER

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

radial ESWT

Intervention Type: 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 Conservative Therapy

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

Group Type: ACTIVE_COMPARATOR

Standard Conservative Therapy

Intervention Type: OTHER

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

Interventions

Standard Conservative Therapy

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

Intervention Type: OTHER

radial ESWT

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fatih Bagcier

OTHER

Sponsor Role: lead

Responsible Party

Fatih Bagcier

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Fatih bağcıer, MD

Role: CONTACT

bagcier_42@hotmail.com

+905442429042

References

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.

Reference Type: RESULT

PMID: 26209782 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24297647 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16403988 (View on PubMed)

Other Identifiers

sba150585

Identifier Type: -

Identifier Source: org_study_id