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

NCT07857499 | Recruiting

• 1 other identifier: 1729903
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipedema

Keywords

Transcutaneous Auricular Vagus Nerve Stimulation; taVNS; Complex Decongestive Therapy; Aerobic Exercise; Pain; Lower Extremity Function; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 6

Secondary Outcomes (7)

• Change in Lower Extremity Volume

  Baseline and week 6

• Change in Body Composition

  Baseline and week 6

• Change in Heart Rate Variability

  Baseline and week 6

• Change in Lower Extremity Functional Status

  Baseline and week 6

• Change in Functional Capacity

  Baseline and week 6

Study Arms (2)

Arm 1 - Experimental

EXPERIMENTAL

taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT)

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)

Device: Sham taVNS; Other: Aerobic Exercise; Other: Complex Decongestive Therapy (CDT)

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.

Arm 1 - Experimental

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.

Arm 2 - Sham Comparator

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.

Arm 1 - Experimental; Arm 2 - Sham Comparator

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.

Arm 1 - Experimental; Arm 2 - Sham Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyupsultan, 34250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lipedema; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

merve sevinç gündüz, MSc

CONTACT

05312991841; mrvsevinccc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 5, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)