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

Condition(s) studied

Investigational drug(s) / intervention(s)

Active taVNS: 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: 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: 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): 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 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 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.

Eligibility

Primary outcome measure(s)

• Change in Pain Intensity — 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.

Trial sites (1)

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