TaVNS added to physiotherapy for adhesive capsulitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled trial will compare active transcutaneous auricular vagus nerve stimulation (taVNS) plus standard physiotherapy to sham taVNS plus the same physiotherapy in adults with adhesive capsulitis. Forty participants, aged 18 to 65, will receive 15 sessions of physiotherapy over 3 weeks, with either active or sham taVNS for 30 minutes daily. Outcomes include changes in pain, shoulder disability, range of motion, and health-related quality of life, assessed before treatment and after the 15th session. The study aims to determine if taVNS provides additional benefit when combined with conventional rehabilitation. Safety and tolerability of the combined approach will also be monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 65 years.
* Clinical diagnosis of adhesive capsulitis confirmed by physical examination and, when clinically indicated, imaging.
* Shoulder pain and limitation of shoulder range of motion for at least 3 months.
* Provision of written informed consent.
* General health status sufficient to participate in standard physiotherapy and active or sham transcutaneous auricular vagus nerve stimulation.
* Ability to comply with the planned treatment sessions and outcome assessments.

Exclusion Criteria:

* Shoulder stiffness secondary to trauma, surgery, infection, or tumor.
* Rotator cuff tear, advanced glenohumeral osteoarthritis, or inflammatory rheumatic disease.
* Glucocorticoid injection into the affected shoulder within the previous 3 months.
* Surgical intervention involving the affected shoulder within the previous 6 months.
* Active infection or skin lesion in the shoulder region.
* Cervical radiculopathy, brachial plexopathy, stroke, or another neurological disorder affecting the upper extremity.
* Presence of a cardiac pacemaker or another implanted electronic device.
* Pregnancy or breastfeeding.
* Serious systemic disease or cognitive impairment that may prevent compliance with the study protocol.
* Known intolerance or previous adverse reaction to transcutaneous electrical stimulation.

Where it's running

• Liv hospital Vadistanbul
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Muhsin Doran — Liv Hospital Vadistanbul
• Study coordinator: Muhsin Doran, MD
• Email: muhsin-doran@hotmail.com
• Phone: 05340807940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.