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NCT Number: NCT07520942

TECAR and ESWT in Obesity-Related Lower Limb Lymphedema

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Modawah Physical Therapy Center

Banī Suwayf, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex Decongestive Therapy

Other

Complex decongestive therapy includes manual lymphatic drainage, multilayer compression bandaging, therapeutic exercises, and skin care education, delivered five times per week for four weeks.

TECAR Therapy

Device

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.

Extracorporeal Shock Wave Therapy

Device

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.

Primary outcomes

  1. Change in lower limb circumference

    Time frame: Limb circumference measured at standardized anatomical landmarks including ankle, calf, knee, mid-thigh, and upper thigh using a non-stretch tape measure.

    Baseline, 4 weeks, and 8 weeks

Secondary outcomes

  1. Tissue stiffness (tonometry)

    Time frame: Tissue stiffness measured using a tonometer at calf and thigh regions.

    Baseline, 4 weeks, and 8 weeks

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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