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"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"

25 maja 2026 zaktualizowane przez: Zeinab Abd el fattah Ali, Cairo University

Lipedema is a chronic condition that mainly affects women and causes abnormal fat accumulation, pain, heaviness, tenderness, swelling, and difficulty with movement, especially in the lower limbs. Liposuction is sometimes used to reduce the abnormal fatty tissue in people with lower-limb lipedema. However, after surgery, patients may still experience swelling, pain, bruising, tissue stiffness, and reduced mobility during recovery.

Physiotherapy is an important part of recovery after liposuction for lipedema. It may include compression therapy, manual lymphatic drainage, gentle exercises, walking, skin care, and patient education. These treatments aim to reduce swelling, improve circulation, support tissue healing, and help patients return to daily activities.

This study will investigate whether adding Endermologie to a standard physiotherapy program can improve recovery after liposuction for lower-limb lipedema. Endermologie is a non-invasive mechanical massage technique that uses gentle suction and rolling movements to mobilize the skin and soft tissues. It may help support lymphatic drainage, reduce swelling, improve tissue flexibility, and decrease discomfort.

Participants in this study will be divided into two groups. One group will receive only standard postoperative physiotherapy. The other group will receive standard postoperative physiotherapy plus Endermologie sessions. The study will compare both groups to see whether Endermologie-assisted physiotherapy provides a better improvement in swelling, pain, tissue stiffness, mobility, and overall functional recovery.

The results of this study may help physiotherapists develop more effective rehabilitation protocols for patients recovering from liposuction for lower-limb lipedema.

Przegląd badań

Szczegółowy opis

This study will evaluate the effect of adding Endermologie to a standard postoperative physiotherapy program for patients recovering from liposuction for lower-limb lipedema.

Lipedema is a chronic disorder of abnormal fat distribution that commonly affects the lower limbs and may be associated with pain, heaviness, tenderness, swelling tendency, bruising, and reduced mobility. Although liposuction may reduce pathological adipose tissue, postoperative recovery often requires structured rehabilitation to manage swelling, pain, tissue stiffness, and functional limitations.

Participants will be assigned to one of two treatment groups. The control group will receive standard postoperative physiotherapy, which may include compression guidance, manual lymphatic drainage, gentle therapeutic exercises, walking progression, lower-limb elevation advice, skin care education, and activity modification. The intervention group will receive the same standard physiotherapy program with the addition of Endermologie sessions.

Endermologie is a non-invasive mechanical soft-tissue mobilization technique using controlled suction and rolling movements. In this study, it will be applied as an adjunctive modality after surgical clearance and according to patient tolerance. Treatment intensity and duration will be adjusted based on healing status, pain level, and tissue response. Areas with open wounds, infection, hematoma, seroma, or excessive tenderness will be avoided.

The study will assess changes in postoperative edema, pain, and functional recovery over the intervention period. Edema may be evaluated using standardized lower-limb circumference or volume measurements. Pain may be assessed using a validated pain rating scale. Functional recovery may be evaluated using mobility or lower-limb function measures. Additional observations may include tissue stiffness, tenderness, heaviness, bruising, patient satisfaction, and quality of life.

The purpose of this study is to determine whether Endermologie-assisted physiotherapy provides additional benefits compared with standard physiotherapy alone in improving postoperative recovery after liposuction for lower-limb lipedema.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

88

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Cairo, Egipt
        • Outpatient Physiotherapy Clinic in al rahma hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

Participants will be eligible for inclusion if they meet all of the following criteria:

Female participants diagnosed with lower-limb lipedema. Age between 25 and 45 years old.

  • Clinical diagnosis of lipedema confirmed by the treating physician or specialist physiotherapist.
  • Lipedema stage II or stage III based on clinical presentation, including disproportionate fat deposition, pain/tenderness, easy bruising, tissue nodularity, or lobular tissue changes.
  • Scheduled for or recently underwent lower-limb liposuction for lipedema management.
  • Body mass index (BMI) between 25 and 35 kg/m².
  • Medically stable and cleared by the treating surgeon to start postoperative physiotherapy.
  • Ability to understand instructions and comply with treatment visits and assessment procedures.
  • Willingness to wear prescribed compression garments according to the postoperative protocol.

3.2 Exclusion Criteria

  • Primary or secondary lymphedema unrelated to lipedema, unless clearly differentiated and documented.
  • Lipedema stage IV with advanced lipo-lymphedema requiring complex decongestive therapy beyond the study protocol.
  • BMI greater than 35 kg/m² or less than 25 kg/m².
  • Uncontrolled diabetes mellitus, uncontrolled hypertension, severe cardiovascular disease, renal disease, hepatic disease, or active systemic inflammatory disease.
  • Deep vein thrombosis, active thrombophlebitis, severe peripheral arterial disease, or untreated varicose complications.
  • Active infection, open wounds, skin ulceration, cellulitis, or significant postoperative complications preventing mechanical therapy.
  • Known coagulopathy, current anticoagulation therapy not cleared by the surgeon, or high bleeding risk.
  • Pregnancy or lactation.
  • Previous lower-limb liposuction within the preceding 12 months.
  • Use of other structured edema-reduction interventions during the study period outside the assigned protocol.
  • Inability to attend scheduled follow-up assessments.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: arm 1:Standard Postoperative Physiotherapy
Participants in this arm will receive standard postoperative physiotherapy after liposuction for lower-limb lipedema. The program may include manual lymphatic drainage, compression garment education, gentle exercises, walking progression, breathing exercises, limb elevation advice, skin care, and activity modification to support edema reduction, pain control, tissue healing, and functional recovery.
Standard Postoperative Physiotherapy is a structured rehabilitation program after liposuction for lower-limb lipedema. It includes manual lymphatic drainage, compression garment education, gentle exercises, walking progression, breathing exercises, limb elevation advice, skin care, and activity modification. The program aims to reduce edema and pain, support tissue healing, and improve functional recovery.
Eksperymentalny: arm 2:Endermologie-Assisted Physiotherapy
Standard Postoperative Physiotherapy is a structured rehabilitation program after liposuction for lower-limb lipedema. It includes manual lymphatic drainage, compression garment education, gentle exercises, walking progression, breathing exercises, limb elevation advice, skin care, and activity modification. The program aims to reduce edema and pain, support tissue healing, and improve functional recovery.
Mechanical massage-assisted physiotherapy consists of standard postoperative physiotherapy combined with non-invasive mechanical soft-tissue mobilization using controlled suction and rolling movements. The intervention will be applied to the operated lower-limb areas after surgeon clearance and according to patient tolerance. Treatment will aim to support postoperative edema reduction, pain relief, tissue mobility, and functional recovery. Areas with open wounds, infection, hematoma, seroma, severe bruising, excessive tenderness, or other postoperative complications will be avoided.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Lower-limb edema volume:
Ramy czasowe: Baseline to 2,4,8,12 weeks
Circumferential measurements at 4-cm intervals from ankle to proximal thigh; truncated-cone volume estimation; mean percentage change across both limbs
Baseline to 2,4,8,12 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
• Pain intensity
Ramy czasowe: base line(7-10 days post operative),2 ,4, 8, 12 weeks
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
base line(7-10 days post operative),2 ,4, 8, 12 weeks
• Functional status:
Ramy czasowe: base line(7-10 days post operative),2 ,4, 8, 12 weeks
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Participants will rise from a standard chair, walk three meters, turn, return, and sit down. Time will be recorded in seconds, and the best or average of repeated trials will be documented
base line(7-10 days post operative),2 ,4, 8, 12 weeks
Tissue induration/fibrosis
Ramy czasowe: at base line(7-10 days post operative),,4,8,12 weeks
High-frequency ultrasonography of subcutaneous thickness/echogenicity
at base line(7-10 days post operative),,4,8,12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 maja 2025

Zakończenie podstawowe (Rzeczywisty)

12 kwietnia 2026

Ukończenie studiów (Rzeczywisty)

12 maja 2026

Daty rejestracji na studia

Pierwszy przesłany

25 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 maja 2026

Pierwszy wysłany (Rzeczywisty)

1 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 maja 2026

Ostatnia weryfikacja

1 stycznia 2025

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Typ informacji pomocniczych dotyczących udostępniania IPD

  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Standard Postoperative Physiotherapy

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