Noninvasive vagus nerve stimulation plus exercises for frozen shoulder
Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07368751 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.