Lower-Limb LipedemaNCT07618065
"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"
A study testing Endermologie-Assisted Physiotherapy and Standard Postoperative Physiotherapy in people with Lower-Limb Lipedema and Lipedema, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Lower-Limb Lipedema, Lipedema
- What is being tested?
- Endermologie-Assisted Physiotherapy and Standard Postoperative Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2026to 12 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Recruiting
Outpatient Physiotherapy Clinic in al rahma hospital
Cairo, Nozha
- Completed
Outpatient Physiotherapy Clinic in al rahma hospital
Cairo
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lower-Limb Lipedema, Lipedema
- Being tested
- Endermologie-Assisted Physiotherapy, Standard Postoperative Physiotherapy
- Keywords
- Lower-limb lipedema; Liposuction; Endermologie; Postoperative physiotherapy; Edema management; Postoperative pain; Functional recovery;
- Medical subject headings
- Lipedema, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endermologie-Assisted PhysiotherapyDevice
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.
Standard Postoperative PhysiotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standard Postoperative Physiotherapy |
| arm 2:Endermologie-Assisted Physiotherapy | Experimental | Not described Receives: Device: Endermologie-Assisted Physiotherapy; Device: Standard Postoperative Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 2,4,8,12 weeks
Secondary outcomes (3)
• Pain intensity
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: base line(7-10 days post operative),2 ,4, 8, 12 weeks
• Functional status:
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
Measured: base line(7-10 days post operative),2 ,4, 8, 12 weeks
Tissue induration/fibrosis
High-frequency ultrasonography of subcutaneous thickness/echogenicity
Measured: at base line(7-10 days post operative),,4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Oct 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-Limb LipedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Abd el fattah Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618065
- Sponsor's protocol ID
- P.T.REC/012/006163
- Status last verified
- Oct 2026
- First submitted
- 25 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"
- ClinicalTrials.gov ID
- NCT07618065
- Acronym / sponsor ID
- P.T.REC/012/006163
- Conditions
- Lower-Limb Lipedema, Lipedema
- Keywords
- Lower-limb lipedema; Liposuction; Endermologie; Postoperative physiotherapy; Edema management; Postoperative pain; Functional recovery;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 1 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| arm 1:Standard Postoperative Physiotherapy | Active comparator | Device: Standard Postoperative PhysiotherapyParticipants 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. |
| arm 2:Endermologie-Assisted Physiotherapy | Experimental | Device: Endermologie-Assisted Physiotherapy, Device: Standard Postoperative Physiotherapy |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endermologie-Assisted PhysiotherapyMechanical 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. | Device | arm 2:Endermologie-Assisted Physiotherapy |
| Standard Postoperative PhysiotherapyStandard 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. | Device | arm 1:Standard Postoperative Physiotherapy, arm 2:Endermologie-Assisted Physiotherapy |
Primary outcome
Lower-limb edema volume:
Time frame: 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
3 secondary outcomes
• Pain intensity
Time frame: base line(7-10 days post operative),2 ,4, 8, 12 weeks
• Functional status:
Time frame: base line(7-10 days post operative),2 ,4, 8, 12 weeks
Tissue induration/fibrosis
Time frame: at base line(7-10 days post operative),,4,8,12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endermologie-Assisted Physiotherapy and Standard Postoperative Physiotherapy in people with Lower-Limb Lipedema and Lipedema, run by Cairo University at 2 sites 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 21 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Ali, Assistant professor (+966557647507, zahamada@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-limb edema volume: (time frame: Baseline to 2,4,8,12 weeks). 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 22 Oct 2026.