TECAR and ESWT in Obesity-Related Lower Limb Lymphedema

NCT07520942 | Completed

• 1 other identifier: SREC.PT.SUE (19)1025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Lymphedema

Keywords

Secondary lymphedema; Severe obesity; Complex decongestive therapy; Extracorporeal shock wave therapy; Transfer energy capacitive and resistive therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tissue stiffness (tonometry)

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

Study Arms (3)

CDT

EXPERIMENTAL

Participants receive complex decongestive therapy including manual lymphatic drainage, compression bandaging, therapeutic exercises, and skin care.

Other: Complex Decongestive Therapy

CDT + TECAR

EXPERIMENTAL

Participants receive complex decongestive therapy combined with TECAR therapy, a radiofrequency treatment applied to improve microcirculation and lymphatic drainage.

Other: Complex Decongestive Therapy; Device: TECAR Therapy

CDT + ESWT

EXPERIMENTAL

Participants receive complex decongestive therapy combined with extracorporeal shock wave therapy applied to enhance lymphatic function and reduce tissue fibrosis.

Other: Complex Decongestive Therapy; Device: Extracorporeal Shock Wave Therapy

Interventions

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.

CDT; CDT + ESWT; CDT + TECAR

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.

CDT + TECAR

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.

CDT + ESWT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (1)

Modawah Physical Therapy Center

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Lymphedema; Obesity; Overweight; Obesity, Morbid

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation. Participants were instructed not to disclose their assigned treatment to the assessors. Due to the nature of the interventions, therapists and participants were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to one of three parallel groups: complex decongestive therapy (CDT) alone, CDT combined with TECAR therapy, or CDT combined with extracorporeal shock wave therapy (ESWT). Each group received a different intervention concurrently over a 4-week treatment period, with follow-up assessments conducted at 8 weeks.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: October 25, 2025
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

EG (1)