"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Cairo, Egypten
- Outpatient Physiotherapy Clinic in al rahma hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lower-limb edema volume:
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
• Pain intensity
Tidsramme: 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:
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P.T.REC/012/006163
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Standard Postoperative Physiotherapy
-
Cedars-Sinai Medical CenterRekrutteringStressurininkontinensForenede Stater
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR)Afsluttet
-
University of CyprusUniversity of Crete; Nicosia General HospitalRekruttering
-
Sunnybrook Health Sciences CentreAfsluttetRotator cuff patologiCanada
-
University of AarhusUkendt
-
Essentia HealthAktiv, ikke rekrutterendeBrystkræft | Træthed | Sarkopeni
-
Fatih Sultan Mehmet Training and Research HospitalAfsluttetAnkelbrud | Syndesmotiske skader | Postoperativ rehabiliteringKalkun
-
London Health Sciences Centre Research Institute...Afsluttet
-
Stanford UniversityTrukket tilbageForreste korsbåndsskader | KnæskaderForenede Stater
-
Sharif Medical Research CenterAfsluttet