RecruitingNot ApplicableNCT07368751

Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial

Sponsor

Istanbul University - Cerrahpasa

Enrollment

40 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Frozen Shoulder

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.

Eligibility

Min Age: 40 YearsMax Age: 65 Years

Inclusion Criteria5

Age between 40 and 65 years.
Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).
More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.
Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.
Shoulder pain lasting at least 3 months during activities of daily living.

Exclusion Criteria7

Passive joint range of motion within normal limits
External rotation range of motion \<30°
Radiographic evidence of glenohumeral arthritis
Presence of inflammatory joint disease
Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)
Pain intensity \<3 according to the Numerical Pain Rating Scale (NPRS)
Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy

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Interventions

OTHERActive 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.

OTHERSham 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.