RecruitingNot ApplicableNCT07711353

Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis

Effect of Transcutaneous Auricular Vagus Nerve Stimulation Added to Standard Physiotherapy on Pain, Function, and Quality of Life in Patients With Shoulder Adhesive Capsulitis: A Randomized Controlled Trial

Sponsor

Muhsin Doran

Enrollment

40 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

Adhesive Capsulitis of the Shoulder

Summary

This randomized, sham-controlled study will evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), when added to standard physiotherapy, improves pain, shoulder function, range of motion, and quality of life in adults with adhesive capsulitis. A total of 40 participants aged 18 to 65 years will be randomly assigned to one of two groups. Both groups will receive 15 sessions of standard physiotherapy over 3 weeks. In addition, one group will receive active taVNS for 30 minutes per day, while the other group will receive sham stimulation for the same duration and frequency. Assessments will be performed before treatment and after the 15th treatment session using pain, shoulder disability, quality-of-life, and shoulder range-of-motion measurements.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physiotherapy, and others for people with adhesive capsulitis of the shoulder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Active transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. Electrical stimulation will be delivered transcutaneously through an auricular electrode to a vagally innervated region of the external ear. The physiotherapist administering the stimulation will be aware of group allocation, while participants and the outcomes assessor will remain blinded.

OTHERConventional Physiotherapy

Participants will receive 15 standard physiotherapy sessions over 3 weeks, with five sessions per week. The program will include pain-relieving physical therapy modalities, glenohumeral and scapulothoracic joint mobilization, passive and active-assisted range-of-motion exercises, capsular stretching, and progressive strengthening exercises for the rotator cuff and scapular stabilizing muscles. Treatment intensity and exercise progression will be individualized according to pain severity, irritability, and range-of-motion limitations. The same physiotherapy protocol will be administered to both study arms.

DEVICESham Transcutaneous Auricular Vagus Nerve Stimulation

Sham transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. The sham procedure will follow the same session frequency and duration as the active intervention but will be applied according to a prespecified sham protocol that is not expected to produce therapeutic vagal stimulation. The physiotherapist administering the intervention will be aware of group allocation, while participants and the outcomes assessor will remain blinded.