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

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema; Obesity & Overweight
• Intervention / Treatment: Other: Complex Decongestive Therapy; Device: TECAR Therapy; Device: Extracorporeal Shock Wave Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Modawah Physical Therapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients aged 18-75 years with bilateral lower limb lymphedema secondary to severe obesity (BMI ≥40 kg/m²)
• Lymphedema duration of at least 3 months
• Clinical diagnosis confirmed by an experienced lymphedema specialist with bilateral limb swelling (pitting or non-pitting edema extending above the ankle)
• Ability to attend treatment sessions five times weekly for 4 weeks and follow-up assessments

Exclusion Criteria:

• Secondary lymphedema due to malignancy, radiation, surgery, or infection
• Primary lymphedema
• Acute deep vein thrombosis or history of recurrent thrombosis
• Active infection or cellulitis
• Peripheral arterial disease with ankle-brachial index below 0.8
• Uncontrolled cardiac failure or renal insufficiency
• Pregnancy or lactation
• Contraindications to ESWT or TECAR therapy including pacemaker or implanted electronic devices
• Patients receiving concurrent lymphedema treatment or those who had received intensive treatment within the preceding 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDT; Participants receive complex decongestive therapy including manual lymphatic drainage, compression bandaging, therapeutic exercises, and skin care.	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.
Experimental: CDT + TECAR; Participants receive complex decongestive therapy combined with TECAR therapy, a radiofrequency treatment applied to improve microcirculation and lymphatic drainage.	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.
Experimental: CDT + ESWT; Participants receive complex decongestive therapy combined with extracorporeal shock wave therapy applied to enhance lymphatic function and reduce tissue fibrosis.	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limb circumference	Baseline, 4 weeks, and 8 weeks	Limb circumference measured at standardized anatomical landmarks including ankle, calf, knee, mid-thigh, and upper thigh using a non-stretch tape measure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue stiffness (tonometry)	Baseline, 4 weeks, and 8 weeks	Tissue stiffness measured using a tonometer at calf and thigh regions.

Collaborators and Investigators

• Sponsor: Applied Science Private University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2025
• Primary Completion (Actual): February 6, 2026
• Study Completion (Actual): February 6, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Severe obesity; Extracorporeal shock wave therapy; Complex decongestive therapy; Secondary lymphedema; Transfer energy capacitive and resistive therapy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Lymphatic Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Overweight; Obesity; Lymphedema; Obesity, Morbid; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: SREC.PT.SUE (19)1025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No