LipedemaLIPO-ESWTNCT07683559
Extracorporeal Shock Wave Therapy in Patients With Lipedema
A study testing Extracorporeal Shock Wave Therapy in people with Lipedema, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic adipose tissue disorder characterized by pain, tenderness, disproportionate fat accumulation, and impaired quality of life. Extracorporeal shock wave therapy (ESWT) has been proposed as a non-invasive treatment option that may improve pain and tissue characteristics in patients with lipedema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lipedema
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 75 years
- Clinical diagnosis of lipedema
- Willingness to participate and provide written informed consent
- Ability to comply with study procedures and follow-up assessments
Who cannot join
- Pregnancy or breastfeeding
- Active infection in the treatment area
- Malignancy
- Severe cardiovascular disease
- Coagulation disorders or current anticoagulant therapy
- Previous ESWT treatment within the last 6 months
- Severe psychiatric or cognitive disorders interfering with study participation
- Any condition deemed by the investigator to make participation unsafe
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Istanbul
Elif Ozyigit, MD, +902124041500, dr.elifoz16@gmail.com
Elif Ozyigit, MD
About this study
Official title: Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings in Patients With Lipedema
Lipedema is a chronic adipose tissue disorder characterized by pain, tenderness, disproportionate fat accumulation, and impaired quality of life. Extracorporeal shock wave therapy (ESWT) has been proposed as a non-invasive treatment option that may improve pain and tissue characteristics in patients with lipedema.
The aim of this prospective interventional study is to evaluate the effects of ESWT on pain intensity, quality of life, functional outcomes, and ultrasonographic findings in patients diagnosed with lipedema. Participants will receive a standardized ESWT protocol consisting of six treatment sessions over a two-week period. Clinical assessments and ultrasonographic examinations will be performed before and after treatment.
Read the detailed description
Lipedema is a chronic progressive disorder of adipose tissue that predominantly affects women and is characterized by symmetrical enlargement of the extremities, pain, tenderness, easy bruising, and reduced quality of life. Despite increasing recognition of the disease, effective treatment options remain limited.
Extracorporeal shock wave therapy (ESWT) has demonstrated beneficial effects in several musculoskeletal and soft tissue disorders through mechanisms including pain modulation, improvement of microcirculation, stimulation of tissue remodeling, and reduction of fibrosis. However, evidence regarding its effectiveness in patients with lipedema remains limited.
This prospective single-arm interventional study aims to investigate the clinical and ultrasonographic effects of ESWT in patients with lipedema. Eligible adult participants diagnosed with lipedema will undergo six ESWT sessions administered three times per week for two consecutive weeks.
Outcome assessments will include pain intensity measured by the Visual Analog Scale (VAS), pressure pain threshold measured by algometry, patient-reported outcomes assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS), Patient Global Impression of Change (PGIC), limb circumference measurements, and ultrasonographic evaluation of tissue characteristics.
Assessments will be performed at baseline and after completion of treatment. The primary objective is to evaluate changes in pain and patient-reported outcomes following ESWT. Secondary objectives include assessment of changes in ultrasonographic findings and limb measurements.
The findings of this study may provide evidence regarding the effectiveness of ESWT as a non-invasive treatment option for patients with lipedema.
- Conditions
- Lipedema
- Being tested
- Extracorporeal Shock Wave Therapy
- Keywords
- Extracorporeal Shock Wave Therapy, ESWT, Lipedema, Pain, Ultrasonography, Quality of Life, PROMIS, Patient-Reported Outcomes
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Extracorporeal shock wave therapy (ESWT) will be applied to affected lower-extremity regions using a CE-marked shock wave device. Participants will receive six treatment sessions administered three times per week for two consecutive weeks. Clinical and ultrasonographic assessments will be performed before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Experimental | Participants with lipedema will receive extracorporeal shock wave therapy (ESWT) administered three times per week for two consecutive weeks, for a total of six treatment sessions. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.
Measured: Baseline and 2 weeks
Secondary outcomes (5)
Change in Pressure Pain Threshold Measured by Pressure Algometry
Pressure pain threshold will be assessed using a digital pressure algometer. The change from baseline to the post-treatment assessment will be analyzed.
Measured: Baseline and 2 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Change in patient-reported global health assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire from baseline to the 2-week post-treatment assessment.
Measured: Baseline and 2 weeks
Change in Pain Catastrophizing Scale (PCS) Score
Change in pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) from baseline to the 2-week post-treatment assessment.
Measured: Baseline and 2 weeks
Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape
Lower extremity circumference will be measured using a flexible measuring tape at standardized anatomical landmarks. The change from baseline to the 2-week post-treatment assessment will be analyzed.
Measured: Baseline and 2 weeks
Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue
Change in ultrasonographic characteristics of the affected skin and subcutaneous tissue assessed by B-mode ultrasonography from baseline to the 2-week post-treatment assessment.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive extracorporeal shock wave therapy (ESWT). Clinical and ultrasonographic assessments will be performed before and after treatment in a single-group pre-post intervention design.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif Ozyigit, MD, Principal investigator, University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683559
- Sponsor's protocol ID
- KSSEAH-LIPO-ESWT-2026
- Other IDs
- Atlas-EC-2026-01-04
- Acronym
- LIPO-ESWT
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study involves locally collected clinical data and no plan has been established for public sharing of individual participant-level datasets.
Publications
Ozyigit E, Un Oguzhanasilturk D, Ozyigit O, Zure M. Clinical and ultrasonographic effects of extracorporeal shock wave therapy in patients with lipedema: A prospective study. Phlebology. 2026 Oct 16:2683555261499797. doi: 10.1177/02683555261499797. Online ahead of print.
PubMed 42886234
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT07683559
- Acronym / sponsor ID
- LIPO-ESWT / KSSEAH-LIPO-ESWT-2026
- Conditions
- Lipedema
- Keywords
- Extracorporeal Shock Wave Therapy, ESWT, Lipedema, Pain, Ultrasonography, Quality of Life, PROMIS, Patient-Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Jul 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 adipose tissue disorder characterized by pain, tenderness, disproportionate fat accumulation, and impaired quality of life. Extracorporeal shock wave therapy (ESWT) has been proposed as a non-invasive treatment option that may improve pain and tissue characteristics in patients with lipedema.
The aim of this prospective interventional study is to evaluate the effects of ESWT on pain intensity, quality of life, functional outcomes, and ultrasonographic findings in patients diagnosed with lipedema. Participants will receive a standardized ESWT protocol consisting of six treatment sessions over a two-week period. Clinical assessments and ultrasonographic examinations will be performed before and after treatment.
Detailed description
Lipedema is a chronic progressive disorder of adipose tissue that predominantly affects women and is characterized by symmetrical enlargement of the extremities, pain, tenderness, easy bruising, and reduced quality of life. Despite increasing recognition of the disease, effective treatment options remain limited.
Extracorporeal shock wave therapy (ESWT) has demonstrated beneficial effects in several musculoskeletal and soft tissue disorders through mechanisms including pain modulation, improvement of microcirculation, stimulation of tissue remodeling, and reduction of fibrosis. However, evidence regarding its effectiveness in patients with lipedema remains limited.
This prospective single-arm interventional study aims to investigate the clinical and ultrasonographic effects of ESWT in patients with lipedema. Eligible adult participants diagnosed with lipedema will undergo six ESWT sessions administered three times per week for two consecutive weeks.
Outcome assessments will include pain intensity measured by the Visual Analog Scale (VAS), pressure pain threshold measured by algometry, patient-reported outcomes assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS), Patient Global Impression of Change (PGIC), limb circumference measurements, and ultrasonographic evaluation of tissue characteristics.
Assessments will be performed at baseline and after completion of treatment. The primary objective is to evaluate changes in pain and patient-reported outcomes following ESWT. Secondary objectives include assessment of changes in ultrasonographic findings and limb measurements.
The findings of this study may provide evidence regarding the effectiveness of ESWT as a non-invasive treatment option for patients with lipedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive extracorporeal shock wave therapy (ESWT). Clinical and ultrasonographic assessments will be performed before and after treatment in a single-group pre-post intervention design.
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Device: Extracorporeal Shock Wave TherapyParticipants with lipedema will receive extracorporeal shock wave therapy (ESWT) administered three times per week for two consecutive weeks, for a total of six treatment sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 to 75 years
- Clinical diagnosis of lipedema
- Willingness to participate and provide written informed consent
- Ability to comply with study procedures and follow-up assessments
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Active infection in the treatment area
- Malignancy
- Severe cardiovascular disease
- Coagulation disorders or current anticoagulant therapy
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 |
|---|---|---|
| Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy (ESWT) will be applied to affected lower-extremity regions using a CE-marked shock wave device. Participants will receive six treatment sessions administered three times per week for two consecutive weeks. Clinical and ultrasonographic assessments will be performed before and after treatment. | Device | ESWT |
Primary outcome
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline and 2 weeks
Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.
5 secondary outcomes
Change in Pressure Pain Threshold Measured by Pressure Algometry
Time frame: Baseline and 2 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Time frame: Baseline and 2 weeks
Change in Pain Catastrophizing Scale (PCS) Score
Time frame: Baseline and 2 weeks
Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape
Time frame: Baseline and 2 weeks
Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue
Time frame: Baseline and 2 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 6 Jul 2026.
- Derived from this study: PubMed 42886234Ozyigit E, Un Oguzhanasilturk D, Ozyigit O, Zure M. Clinical and ultrasonographic effects of extracorporeal shock wave therapy in patients with lipedema: A prospective study. Phlebology. 2026 Oct 16:2683555261499797. doi: 10.1177/02683555261499797. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study involves locally collected clinical data and no plan has been established for public sharing of individual participant-level datasets.
Related trials for Lipedema
Recruiting
"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"
Lower-Limb Lipedema, Lipedema
Not yet recruiting
Telerehabilitation-Supported Exercise in Women With Lipedema
Lipedema
RecruitingObservational study
Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
Lipedema, Obesity
Recruiting
Comparison of Different Exercise Protocols for Diagnosed With Lipedema
Aerobic Exercise, Lipedema
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation-Enriched Rehabilitation in Individuals With Lipedema
Lipedema
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.
Elif Ozyigit, MD principal investigator
University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Lipedema, run by Atlas University at 1 site in Turkey (Türkiye).
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 8 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: opening soon, as of the sponsor's last update on 6 Jul 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 Turkey (Türkiye). 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 Elif Ozyigit, MD (+902124041500, dr.elifoz16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07683559, which also lists 1 linked publication.
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 6 Jul 2026.