NCT07618065

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

Lower-limb lipedema; Liposuction; Endermologie; Postoperative physiotherapy; Edema management; Postoperative pain; Functional recovery;

Outcome Measures

Primary Outcomes (1)

  • Lower-limb edema volume:

    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

Secondary Outcomes (3)

  • • Pain intensity

    base line(7-10 days post operative),2 ,4, 8, 12 weeks

  • • Functional status:

    base line(7-10 days post operative),2 ,4, 8, 12 weeks

  • Tissue induration/fibrosis

    at base line(7-10 days post operative),,4,8,12 weeks

Study Arms (2)

arm 1:Standard Postoperative Physiotherapy

ACTIVE COMPARATOR

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.

Device: Standard Postoperative Physiotherapy

arm 2:Endermologie-Assisted Physiotherapy

EXPERIMENTAL
Device: Endermologie-Assisted PhysiotherapyDevice: Standard Postoperative Physiotherapy

Interventions

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.

arm 1:Standard Postoperative Physiotherapyarm 2:Endermologie-Assisted Physiotherapy

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.

arm 2:Endermologie-Assisted Physiotherapy

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Physiotherapy Clinic in al rahma hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

LipedemaPain, Postoperative

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel-group randomized controlled study designed to compare standard postoperative physiotherapy with Endermologie-assisted physiotherapy in patients after liposuction for lower-limb lipedema. Participants will be randomly allocated to either a control group receiving standard postoperative physiotherapy or an intervention group receiving standard postoperative physiotherapy plus Endermologie. The two groups will be assessed over the same treatment period to evaluate differences in postoperative edema, pain intensity, and functional recovery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy-cairo university

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

May 13, 2025

Primary Completion

April 12, 2026

Study Completion

May 12, 2026

Last Updated

June 1, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF

Locations