LipedemaLipoVNSNCT07857499
Transcutaneous Auricular Vagus Nerve Stimulation-Enriched Rehabilitation in Individuals With Lipedema
A study testing Active taVNS, Aerobic Exercise and Complex Decongestive Therapy (CDT) in people with Lipedema, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic inflammatory disorder of adipose tissue that predominantly affects women and is associated with estrogen-mediated mechanisms. [1] Conservative physiotherapy approaches, including exercise, compression therapy, complex decongestive therapy (CDT), and behavioral interventions, are recommended for… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Active taVNS, Aerobic Exercise and Complex Decongestive Therapy (CDT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2026to 28 Feb 2028
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18-65 years.
- Clinical diagnosis of lipedema confirmed by a specialist physician.
- Bilateral and symmetrical disproportionate adipose tissue accumulation in the lower extremities.
- Pain or tenderness on pressure in the affected areas.
- Negative Stemmer's sign.
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Secondary or iatrogenic obesity due to endocrine disorders or medication use.
- Body weight change greater than 10% within the previous six months.
- Initiation or modification of estrogen-progestin therapy within the previous two months.
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, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Eyupsultan, 34250
merve sevinç gündüz, MSc, 05312991841, mrvsevinccc@gmail.com
About this study
Official title: Effects of Rehabilitation Enriched With Transcutaneous Auricular Vagus Nerve Stimulation on Lower Extremity Function, Pain, and Quality of Life in Individuals With Lipedema
Lipedema is a chronic inflammatory disorder of adipose tissue that predominantly affects women and is associated with estrogen-mediated mechanisms. [1] Conservative physiotherapy approaches, including exercise, compression therapy, complex decongestive therapy (CDT), and behavioral interventions, are recommended for the management of lipedema. [2,3] Transcutaneous auricular vagus nerve stimulation (taVNS) is a neuromodulation method that may reduce pro-inflammatory cytokines through the cholinergic anti-inflammatory pathway and exert metabolic and autonomic regulatory effects. [4] These effects suggest that taVNS may serve as a complementary intervention to exercise and conservative physiotherapy approaches in the management of chronic low-grade inflammation, one of the pathophysiological components of lipedema. In light of this evidence, the aim of this study is to comparatively investigate the effects of taVNS-enhanced rehabilitation versus conventional rehabilitation on lower extremity function, pain, and quality of life in individuals with lipedema.
- Conditions
- Lipedema
- Being tested
- Active taVNS, Sham taVNS, Aerobic Exercise, Complex Decongestive Therapy (CDT)
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, Complex Decongestive Therapy, Aerobic Exercise, Pain, Lower Extremity Function, Quality of Life
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
Active taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. Electrical stimulation will be delivered to the auricular region using a transcutaneous vagus nerve stimulation device.
Sham taVNSDevice
Sham taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. The sham procedure will be performed using the auricular stimulation device without sustained therapeutic electrical stimulation.
Aerobic ExerciseOther
Participants in both groups will receive supervised moderate-intensity treadmill-based aerobic exercise concurrently with active or sham taVNS. Aerobic exercise will be administered for 30 minutes per session, twice weekly for six weeks.
Complex Decongestive Therapy (CDT)Other
Participants in both groups will receive complex decongestive therapy for 30 minutes per session, twice weekly for six weeks, following the concurrent aerobic exercise and active or sham taVNS intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental | Experimental | taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT) Receives: Device: Active taVNS; Other: Aerobic Exercise; Other: Complex Decongestive Therapy (CDT) |
| Arm 2 - Sham Comparator | Sham comparator | Sham taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT) Receives: Device: Sham taVNS; Other: Aerobic Exercise; Other: Complex Decongestive Therapy (CDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in NPRS scores from baseline to week 6 will be evaluated.
Measured: Baseline and week 6
Secondary outcomes (7)
Change in Lower Extremity Volume
Lower extremity volume will be assessed bilaterally using circumferential measurements taken at standardized intervals with a non-elastic measuring tape. Total limb volume will be calculated using the truncated cone (frustum) formula. Changes in limb volume from baseline to week 6 will be evaluated. Results will be expressed in milliliters (mL).
Measured: Baseline and week 6
Change in Body Composition
Body composition will be assessed using bioelectrical impedance analysis (BIA). Measurements will include fat mass, fat-free mass, total body water, and the leg-to-arm impedance ratio. Changes in these parameters from baseline to week 6 will be evaluated.
Measured: Baseline and week 6
Change in Heart Rate Variability
Heart rate variability (HRV) will be assessed using a Polar H10 heart rate monitor, with data analyzed using the Elite HRV application. Time-domain and frequency-domain parameters, including mean RR interval, SDNN, RMSSD, ln(RMSSD), pNN50, LF power, HF power, LF/HF ratio, LF peak, HF peak, and total power, will be evaluated. Changes from baseline to week 6 will be assessed.
Measured: Baseline and week 6
Change in Lower Extremity Functional Status
Description: Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS), a 20-item questionnaire evaluating difficulty in performing daily activities. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 80. Higher scores indicate better lower extremity function. Changes from baseline to week 6 will be evaluated.
Measured: Baseline and week 6
Change in Functional Capacity
Description: Functional capacity will be assessed using the Six-Minute Walk Test (6MWT), conducted along a 30-meter indoor corridor. The total distance walked in six minutes will be recorded in meters. Changes in walking distance from baseline to week 6 will be evaluated.
Measured: Baseline and week 6
Change in Health-Related Quality of Life
Description: Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status. Changes from baseline to week 6 will be evaluated.
Measured: Baseline and week 6
Patient-Perceived Global Change
Description: Patient-perceived change will be assessed using the Global Rating of Change (GRC) Scale, a five-point Likert-type scale ranging from -2 (much worse) to +2 (much better), with 0 indicating no change. Participants will rate their perceived change compared with their pretreatment status.
Measured: Week 6 (to be confirmed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start18 Sep 2026
- Primary completion30 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve SEVINC GUNDUZ, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857499
- Sponsor's protocol ID
- 1729903
- Acronym
- LipoVNS
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation Enriched With Transcutaneous Auricular Vagus Nerve Stimulation on Lower Extremity Function, Pain, and Quality of Life in Individuals With Lipedema
- ClinicalTrials.gov ID
- NCT07857499
- Acronym / sponsor ID
- LipoVNS / 1729903
- Conditions
- Lipedema
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, Complex Decongestive Therapy, Aerobic Exercise, Pain, Lower Extremity Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 Oct 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 inflammatory disorder of adipose tissue that predominantly affects women and is associated with estrogen-mediated mechanisms. [1] Conservative physiotherapy approaches, including exercise, compression therapy, complex decongestive therapy (CDT), and behavioral interventions, are recommended for the management of lipedema. [2,3] Transcutaneous auricular vagus nerve stimulation (taVNS) is a neuromodulation method that may reduce pro-inflammatory cytokines through the cholinergic anti-inflammatory pathway and exert metabolic and autonomic regulatory effects. [4] These effects suggest that taVNS may serve as a complementary intervention to exercise and conservative physiotherapy approaches in the management of chronic low-grade inflammation, one of the pathophysiological components of lipedema. In light of this evidence, the aim of this study is to comparatively investigate the effects of taVNS-enhanced rehabilitation versus conventional rehabilitation on lower extremity function, pain, and quality of life in individuals with lipedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Experimental | Experimental | Device: Active taVNS, Other: Aerobic Exercise, Other: Complex Decongestive Therapy (CDT)taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT) |
| Arm 2 - Sham Comparator | Sham comparator | Device: Sham taVNS, Other: Aerobic Exercise, Other: Complex Decongestive Therapy (CDT)Sham taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged 18-65 years.
- Clinical diagnosis of lipedema confirmed by a specialist physician.
- Bilateral and symmetrical disproportionate adipose tissue accumulation in the lower extremities.
- Pain or tenderness on pressure in the affected areas.
- Negative Stemmer's sign.
Key exclusion criteria (3 listed)
- Secondary or iatrogenic obesity due to endocrine disorders or medication use.
- Body weight change greater than 10% within the previous six months.
- Initiation or modification of estrogen-progestin therapy within the previous two months.
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 |
|---|---|---|
| Active taVNSActive taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. Electrical stimulation will be delivered to the auricular region using a transcutaneous vagus nerve stimulation device. | Device | Arm 1 - Experimental |
| Sham taVNSSham taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. The sham procedure will be performed using the auricular stimulation device without sustained therapeutic electrical stimulation. | Device | Arm 2 - Sham Comparator |
| Aerobic ExerciseParticipants in both groups will receive supervised moderate-intensity treadmill-based aerobic exercise concurrently with active or sham taVNS. Aerobic exercise will be administered for 30 minutes per session, twice weekly for six weeks. | Other | Arm 1 - Experimental, Arm 2 - Sham Comparator |
| Complex Decongestive Therapy (CDT)Participants in both groups will receive complex decongestive therapy for 30 minutes per session, twice weekly for six weeks, following the concurrent aerobic exercise and active or sham taVNS intervention. | Other | Arm 1 - Experimental, Arm 2 - Sham Comparator |
Primary outcome
Change in Pain Intensity
Time frame: Baseline and week 6
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in NPRS scores from baseline to week 6 will be evaluated.
7 secondary outcomes
Change in Lower Extremity Volume
Time frame: Baseline and week 6
Change in Body Composition
Time frame: Baseline and week 6
Change in Heart Rate Variability
Time frame: Baseline and week 6
Change in Lower Extremity Functional Status
Time frame: Baseline and week 6
Change in Functional Capacity
Time frame: Baseline and week 6
Change in Health-Related Quality of Life
Time frame: Baseline and week 6
Patient-Perceived Global Change
Time frame: Week 6 (to be confirmed)
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS, Aerobic Exercise and Complex Decongestive Therapy (CDT) in people with Lipedema, run by Istanbul University - Cerrahpasa 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 6 inclusion and 3 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 5 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 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. Some participants in this study may receive a placebo. 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 merve sevinç gündüz, MSc (05312991841, mrvsevinccc@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 (time frame: Baseline and week 6). 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 5 Oct 2026.