Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis (NCT07711353) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis
Turkey (Türkiye)40 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Shoulder Pain and Disability Index (SPADI) Total Score
Timeframe: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks