Transcutaneous Auricular Vagus Nerve Stimulation in Upper Extremity Lymphedema

Summary

Lymphedema is an inflammatory disease characterized by abnormal accumulation of excess water, plasma proteins, and extravascular blood and parenchymal cells in the affected upper and lower arms, chest and/or trunk due to inadequate lymphatic transport capacity, and is associated with high-severity, recurrent soft tissue infections that can lead to sepsis and even death. Although there is no definitive treatment for lymphedema, a Complex Decongestive Treatment approach that includes manual lymph drainage, skin care, special exercises, compression and personal care has been described to slow down the progression of the disease and prevent secondary complications. In addition, parasympathetic nerve activation has been described, similar to vagus nerve activation with manual lymphatic drainage. system activation can be increased. The aim of our study was to investigate the effect of transcutaneous auricular vagus nerve stimulation on quality of life, grip strength and manual dexterity in patients with unilateral upper extremity lymphedema. It was planned as a randomized controlled experimental study. The universe of the study will consist of lymphedema patients hospitalized in Gaziosmanpaşa Physical Therapy Rehabilitation Education and Research Hospital, and the sample will consist of 27 volunteer patients who meet the inclusion and exclusion criteria. The study was planned as a single-center (Gaziosmanpaşa Education and Research Hospital). Participants will be randomly divided into three groups. The groups will be determined by simple randomization method. Only Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach will be applied to the first group, Complex Decongestive Treatment and sham transcutaneous vagus nerve stimulation will be applied to the second group, and transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Treatment to the third group. Data collected from the patients will be entered into SPSS 21.0 package program to create a data set and statistical analyses will be performed.

Conditions

• Quality of Life
• Lymphedema
• Hand Grasp
• Grip
• Strength
• Edema

Interventions

OTHER

Complex Decongestive Treatment

Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach. It will be applied 5 days a week for 3 weeks

OTHER

Sham transcutaneous vagus nerve stimulation

In sham transcutaneous vagus nerve stimulation application, the device electrode will be placed in the superior scapha region of the outer ear, where the vagus nerve has no innervation, and no current will be given.Complex Decongestive Therapy and sham transcutaneous vagus nerve stimulation.It will be applied 5 days a week for 3 weeks.

OTHER

Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Therapy.It will be applied 5 days a week for 3 weeks.

OTHER

Exercise

Patients will undergo lymphedema-specific exercises 5 days a week for 3 weeks.

Sponsors & Collaborators

• Seda Saka

  lead OTHER

Principal Investigators

• Kevser Gümüşsu, MD · Gaziosmanpaşa Eğitim ve Araştırma Hastanesi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-11

Primary Completion

2024-09-11

Completion

2024-12-11

Countries

• Turkey (Türkiye)

Study Locations