NCT07520942

TECAR and ESWT in Obesity-Related Lower Limb Lymphedema

The Effect of TECAR Therapy and Extracorporeal Shock Wave Therapy Combined With Complex Decongestive Therapy in the Treatment of Bilateral Lower-Limb Secondary Lymphedema in Severely Obese Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Applied Science Private University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial evaluates the effectiveness of adding TECAR therapy or extracorporeal shock wave therapy (ESWT) to complex decongestive therapy (CDT) in the treatment of bilateral lower-limb lymphedema in severely obese patients. Forty-five female participants were randomly assigned to one of three groups: CDT alone, CDT combined with TECAR, or CDT combined with ESWT. The interventions were applied over a four-week period. The primary outcome was reduction in limb circumference, while secondary outcomes included quality of life, pain intensity, and tissue stiffness. Assessments were conducted at baseline, after 4 weeks of treatment, and at 8 weeks follow-up.

Detailed description

Lymphedema associated with severe obesity is a chronic and progressive condition characterized by bilateral lower-limb swelling, pain, reduced mobility, and impaired quality of life. Complex decongestive therapy (CDT) is considered the standard treatment; however, its effectiveness may be limited in patients with severe obesity due to underlying fibrosis, inflammation, and adipose tissue accumulation. Adjunctive therapies such as transfer energy capacitive and resistive (TECAR) therapy and extracorporeal shock wave therapy (ESWT) have been proposed to enhance treatment outcomes. TECAR therapy uses radiofrequency energy to improve microcirculation and promote lymphatic drainage, while ESWT may stimulate lymphangiogenesis and reduce tissue fibrosis. This prospective randomized controlled trial aimed to compare the effectiveness of CDT alone with CDT combined with TECAR or ESWT in severely obese patients with bilateral lower-limb lymphedema. A total of 45 female participants were randomly assigned into three groups: CDT alone, CDT plus TECAR therapy, and CDT plus ESWT. All interventions were administered over a four-week period. Outcome measures included limb circumference as the primary outcome, and quality of life (LYMQOL), pain intensity (VAS), and tissue stiffness (tonometry) as secondary outcomes. Assessments were conducted at baseline, after 4 weeks of treatment, and at 8 weeks follow-up. The findings of this study aim to provide evidence on the effectiveness of adjunctive therapies in improving clinical outcomes in obesity-related lymphedema and support clinical decision-making in this population.

Conditions

• Lymphedema
• Obesity & Overweight

Interventions

Type	Name	Description
OTHER	Complex Decongestive Therapy	Complex decongestive therapy includes manual lymphatic drainage, multilayer compression bandaging, therapeutic exercises, and skin care education, delivered five times per week for four weeks.
DEVICE	TECAR Therapy	TECAR therapy is a capacitive-resistive radiofrequency treatment applied at 448 kHz to improve microcirculation and lymphatic drainage. It is delivered for 20 minutes per limb, five times per week for four weeks, in combination with complex decongestive therapy.
DEVICE	Extracorporeal Shock Wave Therapy	Extracorporeal shock wave therapy is a radial shock wave treatment applied to areas of edema and tissue stiffness. Each limb receives 2000 shocks at 0.10-0.15 mJ/mm² and 8-10 Hz, three times per week for four weeks, in combination with complex decongestive therapy.

Timeline

• Start date: 2025-10-25
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Egypt