TECAR and ESWT in Obesity-Related Lower Limb Lymphedema (NCT07520942) | Clinical Trial Compass
CompletedNot Applicable
TECAR and ESWT in Obesity-Related Lower Limb Lymphedema
Egypt45 participantsStarted 2025-10-25
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in lower limb circumference
Timeframe: Limb circumference measured at standardized anatomical landmarks including ankle, calf, knee, mid-thigh, and upper thigh using a non-stretch tape measure.