LymphedemaNCT07520942
TECAR and ESWT in Obesity-Related Lower Limb Lymphedema
A study testing Complex Decongestive Therapy, TECAR Therapy and Extracorporeal Shock Wave Therapy in people with Lymphedema and Obesity & Overweight, run by Applied Science Private University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema, Obesity & Overweight
- What is being tested?
- Complex Decongestive Therapy, TECAR Therapy and Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2025to 6 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Complex Decongestive Therapy, TECAR Therapy, Extracorporeal Shock Wave Therapy
- Keywords
- Secondary lymphedema, Severe obesity, Complex decongestive therapy, Extracorporeal shock wave therapy, Transfer energy capacitive and resistive therapy
- Medical subject headings
- Lymphedema, Obesity, Overweight, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive TherapyOther
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 TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CDT | Experimental | Participants receive complex decongestive therapy including manual lymphatic drainage, compression bandaging, therapeutic exercises, and skin care. Receives: 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. Receives: 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. Receives: Other: Complex Decongestive Therapy; Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb circumference
Baseline, 4 weeks, and 8 weeks
Measured: 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)
Baseline, 4 weeks, and 8 weeks
Measured: Tissue stiffness measured using a tonometer at calf and thigh regions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start25 Oct 2025
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520942
- Sponsor's protocol ID
- SREC.PT.SUE (19)1025
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07520942
- Acronym / sponsor ID
- SREC.PT.SUE (19)1025
- Conditions
- Lymphedema, Obesity & Overweight
- Keywords
- Secondary lymphedema, Severe obesity, Complex decongestive therapy, Extracorporeal shock wave therapy, Transfer energy capacitive and resistive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CDT | Experimental | Other: Complex Decongestive TherapyParticipants receive complex decongestive therapy including manual lymphatic drainage, compression bandaging, therapeutic exercises, and skin care. |
| CDT + TECAR | Experimental | Other: Complex Decongestive Therapy, Device: TECAR TherapyParticipants receive complex decongestive therapy combined with TECAR therapy, a radiofrequency treatment applied to improve microcirculation and lymphatic drainage. |
| CDT + ESWT | Experimental | Other: Complex Decongestive Therapy, Device: Extracorporeal Shock Wave TherapyParticipants receive complex decongestive therapy combined with extracorporeal shock wave therapy applied to enhance lymphatic function and reduce tissue fibrosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Decongestive TherapyComplex decongestive therapy includes manual lymphatic drainage, multilayer compression bandaging, therapeutic exercises, and skin care education, delivered five times per week for four weeks. | Other | CDT, CDT + ESWT, CDT + TECAR |
| TECAR TherapyTECAR 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 | CDT + TECAR |
| Extracorporeal Shock Wave TherapyExtracorporeal 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. | Device | CDT + ESWT |
Primary outcome
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
1 secondary outcome
Tissue stiffness (tonometry)
Time frame: Tissue stiffness measured using a tonometer at calf and thigh regions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy, TECAR Therapy and Extracorporeal Shock Wave Therapy in people with Lymphedema and Obesity & Overweight, run by Applied Science Private University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.