NCT07495306 Electrophysiologic Changes After Extended 360° Capsular Release
| NCT ID | NCT07495306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Acibadem University |
| Condition | Adhesive Capsulitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2027-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2026-02-26 with a primary completion date of 2027-02-26.
⚠ 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
Frozen shoulder (adhesive capsulitis) is a condition characterized by shoulder pain and restricted range of motion, significantly impairing daily living activities. In cases that do not respond to conservative treatment, arthroscopic capsular release is an effective surgical treatment option. The 360° capsular release technique, performed by some surgeons, involves release of the inferior capsule and therefore carries a potential risk of nerve injury due to the anatomical proximity of neurovascular structures such as the axillary nerve. In addition, surgical manipulations performed around the coracoid process may exert mechanical or compressive effects on the musculocutaneous nerve and its sensory continuation, the lateral antebrachial cutaneous nerve, due to their close relationship with the lateral cord of the brachial plexus. The aim of this prospective, single-center observational clinical study is to objectively evaluate the morphological and functional effects of inferior capsular release and coracoid region dissection performed during arthroscopic 360° capsular release surgery on the axillary and musculocutaneous nerves, using electromyography (EMG) and nerve conduction studies (NCS) in patients with frozen shoulder. Patients aged 21-70 years with a diagnosis of frozen shoulder who have not responded to conservative treatments and are scheduled for arthroscopic capsular release will be included in the study. EMG and NCS assessments will be performed at the preoperative baseline, and at 12 weeks postoperatively. For the axillary nerve, the deltoid and teres minor muscles will be evaluated; for the musculocutaneous nerve, the biceps brachii and brachialis muscles will be assessed. Additionally, sensory conduction of the lateral antebrachial cutaneous nerve will be examined. Along with electrophysiological findings, shoulder range of motion (ROM), pain (VAS), muscle strength (MRC), and functional scores will also be recorded. This study is expected to provide objective evidence regarding the effects of arthroscopic capsular release surgery on peripheral nerve function, thereby contributing new data on the safety of the surgical technique and enriching the currently limited literature on electromyographic evaluation in frozen shoulder surgery.
Eligibility Criteria
Inclusion Criteria: * Age between 21 and 70 years * Diagnosis of adhesive capsulitis (frozen shoulder) * Persistent symptoms despite conservative treatment (e.g., physical therapy, medication, or intra-articular injections) * Planned arthroscopic capsular release surgery * Ability to provide informed consent Exclusion Criteria: * Known peripheral neuropathy * Previous brachial plexus injury * History of ipsilateral shoulder neurovascular surgery * Previous proximal brachial plexus surgery * Coagulation disorders * Active infection * Pregnancy
Contact & Investigator
Nezih Ziroglu, MD
PRINCIPAL INVESTIGATOR
Acıbadem Mehmet Ali Aydınlar University
Frequently Asked Questions
Who can join the NCT07495306 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Adhesive Capsulitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07495306 currently recruiting?
Yes, NCT07495306 is actively recruiting participants. Contact the research team at nezih.ziroglu@yahoo.com for enrollment information.
Where is the NCT07495306 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07495306 clinical trial?
NCT07495306 is sponsored by Acibadem University. The principal investigator is Nezih Ziroglu, MD at Acıbadem Mehmet Ali Aydınlar University. The trial plans to enroll 15 participants.