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.
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.
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.
Parallel
Active taVNS
DeviceActive 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
DeviceSham 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 interventionParticipants 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 interventionParticipants 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.
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.
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).
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.
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.
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.
Click on the lead sponsor to view all of their trials.
