An observational study in Adhesive Capsulitis and Frozen Shoulder, sponsored by Acibadem University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Acibadem University · Observational
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.
Frozen shoulder (adhesive capsulitis) is a disabling condition characterized by shoulder pain and significant limitation of active and passive range of motion. When conservative treatments such as physical therapy, medications, and intra-articular injections fail, arthroscopic capsular release is commonly performed to restore shoulder mobility.
Arthroscopic 360° capsular release involves circumferential release of the shoulder capsule, including the inferior capsule. Due to the close anatomical relationship of the inferior capsule with the axillary nerve and the proximity of the coracoid region to the lateral cord of the brachial plexus, surgical manipulation in these regions may theoretically affect the axillary and musculocutaneous nerves. While neurological complications after shoulder arthroscopy are considered rare, the electrophysiological effects of capsular release procedures on peripheral nerve function have not been systematically evaluated in prospective studies.
This prospective single-center observational clinical study aims to evaluate the morphological and functional effects of inferior capsular release and peri-coracoid dissection on the axillary and musculocutaneous nerves in patients undergoing arthroscopic 360° capsular release for adhesive capsulitis.
Patients aged 21-70 years with frozen shoulder who do not respond to conservative treatments and are scheduled for arthroscopic capsular release will be included. Electromyography (EMG) and nerve conduction studies (NCS) will be performed at baseline before surgery and repeated during postoperative follow-up.
For the axillary nerve, the deltoid and teres minor muscles will be evaluated using needle EMG. For the musculocutaneous nerve, the biceps brachii and brachialis muscles will be examined. In addition, sensory conduction studies of the lateral antebrachial cutaneous nerve will be performed.
Along with electrophysiological parameters such as motor unit potentials, recruitment patterns, distal latency, conduction velocity, and compound muscle action potential amplitudes, clinical outcomes including shoulder range of motion, pain scores, muscle strength, and functional shoulder scores will also be recorded.
The primary objective of the study is to compare preoperative and postoperative electrophysiological parameters of the axillary and musculocutaneous nerves. Secondary analyses will evaluate the relationship between electrophysiological changes and clinical outcomes such as improvement in range of motion, reduction in pain, and recovery of muscle strength.
This study aims to provide objective electrophysiological data regarding the effects of arthroscopic capsular release on peripheral nerve function and contribute to the limited literature on neurophysiological outcomes following shoulder arthroscopy. Primary Outcome Measure
Change in electrophysiological parameters of axillary and musculocutaneous nerves
Electrophysiological evaluation using electromyography (EMG) and nerve conduction studies (NCS) will be performed preoperatively and at postoperative follow-up to assess changes in nerve conduction velocity, distal latency, CMAP amplitude, and motor unit potential characteristics.
Time Frame: Preoperative baseline and postoperative follow-up. Secondary Outcome Measures
Change in shoulder range of motion (ROM) Measured using standard goniometric evaluation before and after surgery.
Pain level (VAS score) Pain intensity will be evaluated using the Visual Analog Scale.
Muscle strength (MRC scale) Motor strength of the affected upper extremity will be evaluated.
Functional shoulder scores Functional outcome will be assessed using validated shoulder scoring systems such as the ASES score.
Eligibility Criteria Inclusion Criteria
Age between 21 and 70 years
Diagnosis of adhesive capsulitis (frozen shoulder)
Failure of conservative treatment
Scheduled for arthroscopic capsular release surgery
Exclusion Criteria
Known peripheral neuropathy
Previous brachial plexus injury
Previous neurovascular surgery of the ipsilateral shoulder
Coagulation disorders
Active infection
Pregnancy
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This study's planned enrollment of 15 is below the median of 50 across 29 observational studies indexed under Bursitis.
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The study population will consist of adult patients diagnosed with adhesive capsulitis (frozen shoulder) who do not respond to conservative treatment and are scheduled to undergo arthroscopic capsular release surgery. Patients will be recruited from the orthopedic and traumatology clinics of Acibadem University Hospital. All participants will be between 21 and 70 years of age and will undergo standard clinical evaluation and electrophysiological assessment as part of the study protocol.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes patients aged 21-70 years diagnosed with adhesive capsulitis (frozen shoulder) who do not respond to conservative treatment and are scheduled to undergo arthroscopic 360° capsular release. All participants will undergo standard arthroscopic capsular release surgery performed by experienced shoulder surgeons. Electrophysiological evaluation of axillary and musculocutaneous nerve function will be performed using electromyography (EMG) and nerve conduction studies (NCS) before surgery and during postoperative follow-up. Clinical outcomes including shoulder range of motion, pain level, muscle strength, and functional shoulder scores will also be recorded.
Procedure: Arthroscopic 360° Capsular Release
Arthroscopic circumferential capsular release performed for the treatment of adhesive capsulitis. The procedure includes release of the anterior, posterior, and inferior capsule, with careful dissection around the inferior capsule and coracoid region.
Change in CMAP Amplitude of Axillary and Musculocutaneous Nerves
Compound muscle action potential (CMAP) amplitude measured using nerve conduction studies (NCS).
Time frame: Preoperative baseline and 12 weeks after surgery
Change in Distal Motor Latency
Distal motor latency measured using nerve conduction studies (NCS).
Time frame: Preoperative baseline and 12 weeks after surgery
Change in Nerve Conduction Velocity
Motor nerve conduction velocity measured using nerve conduction studies (NCS).
Time frame: Preoperative baseline and 12 weeks after surgery
Shoulder Range of Motion (ROM)
Active and passive shoulder range of motion measured using standard goniometric evaluation.
Time frame: Preoperative baseline and 12 weeks after surgery
Pain Level (VAS)
Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Preoperative baseline and 12 weeks after surgery
Plan to share: Undecided — Individual participant data (IPD) sharing has not yet been determined. Data sharing may be considered upon reasonable request after completion of the study and publication of the results, in accordance with institutional policies and applicable data protection regulations.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.
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