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Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
Sponsor: Istanbul University - Cerrahpasa
Summary
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder. The main questions this study aims to answer are: Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction? Researchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder. Participants will: Receive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy. Attend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.
Official title: Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-02
Completion Date
2027-03-01
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Active tVNS plus exercises
This program will be performed 3 times per week for 6 weeks. Each session will include 30 minutes of tVNS. Stimulation will be delivered to the auricular branch of the vagus nerve using a non-invasive transcutaneous device. Electrodes will be placed on the tragus and concha regions of the ear. in addition to traditional exercises including mobilization, ROM exercises, stretching and strengthening exercises.
Sham controlled tVNS plus exercises
This program will be performed three times per week for six weeks. In each session, 30 minutes of sham tVNS will be applied, during which the device will remain inactive, in addition to traditional exercise therapy including joint mobilization, range of motion exercises, stretching, and strengthening exercises.
Locations (1)
Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye)