RECRUITING Not applicable ClinicalTrials.gov

Transcutaneous Auricular Vagus Nerve Stimulation-Enriched Rehabilitation in Individuals With Lipedema

Sponsor: Istanbul University - Cerrahpasa • ClinicalTrials.gov ID: NCT07857499

Registry updated: 2026-10-05

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Active taVNS (Device)
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 taVNS (Device)
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 Exercise (Other)
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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Lipedema

Locations

Bezmialem Vakif University — Istanbul, Eyupsultan, Turkey (Türkiye)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment