Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis

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.

Conditions

• Adhesive Capsulitis of the Shoulder

Interventions

DEVICE

Active 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.

OTHER

Conventional 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.

DEVICE

Sham 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.

Sponsors & Collaborators

• Muhsin Doran

  lead OTHER

Principal Investigators

• Muhsin Doran · Liv Hospital Vadistanbul

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-10

Primary Completion

2026-10-01

Completion

2026-10-01

Countries

• Turkey (Türkiye)

Study Locations