Noninvasive vagus nerve stimulation plus exercises for frozen shoulder
Official title: Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
Run by Istanbul University - Cerrahpasa · NCT07368751 · Data updated 2026-11-12
This test will see if adding noninvasive vagus nerve stimulation to a 6‑week exercise program helps adults with frozen shoulder reduce pain, improve shoulder movement, and feel better psychologically.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | February 15, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT07368751 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 40–65 years old with at least three months of frozen shoulder pain and documented loss of range of motion who have not received prior physiotherapy, injections, or surgery for the current shoulder problem.
✕Probably not a fit
Patients with mild pain (<3/10), radiographic glenohumeral arthritis, inflammatory joint disease, significant neurological or cardiac disorders, prior treatment for the current shoulder complaint, or external rotation <30° are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double‑blind, sham‑controlled trial comparing active transcutaneous vagus nerve stimulation (tVNS) plus supervised exercise with sham tVNS plus the same exercise program. Eligible participants are adults aged 40–65 with at least three months of shoulder pain and documented loss of range of motion consistent with frozen shoulder. Participants attend supervised rehabilitation three times per week for six weeks and follow a home exercise program, while outcome assessors are blinded to allocation. Primary outcomes include pain, shoulder function, range of motion, psychological measures, and patient satisfaction.
Why it matters
Potential benefit: If successful, adding tVNS could offer a noninvasive way to reduce pain, improve shoulder motion, and increase patient satisfaction beyond exercise alone.
How similar studies have gone: Small preliminary studies of transcutaneous vagus nerve stimulation have shown promise for reducing pain and improving psychological symptoms in other conditions, but its use specifically for frozen shoulder is novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Salam Alruz, Msc — Istanbul University - Cerrahpasa
- Study coordinator: Salam Alruz, MSc
- Email: salamalruz@gmail.com
- Phone: +90 5510805265
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.