NCT07368751 Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
| NCT ID | NCT07368751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Frozen Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-02 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder. The main questions this study aims to answer are: Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction? Researchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder. Participants will: Receive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy. Attend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.
Eligibility 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
Contact & Investigator
Salam Alruz, Msc
PRINCIPAL INVESTIGATOR
Istanbul University - Cerrahpasa
Frequently Asked Questions
Who can join the NCT07368751 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Frozen Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07368751 currently recruiting?
Yes, NCT07368751 is actively recruiting participants. Contact the research team at salamalruz@gmail.com for enrollment information.
Where is the NCT07368751 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07368751 clinical trial?
NCT07368751 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Salam Alruz, Msc at Istanbul University - Cerrahpasa. The trial plans to enroll 40 participants.