Electrophysiologic Changes After Extended 360° Capsular Release

NCT07495306 | Recruiting

• 1 other identifier: ACU-ORT- 2026-03/34
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis; Frozen Shoulder

Keywords

Adhesive Capsulitis; 360° Capsular Release; Shoulder Arthroscopy; Electromyography; Axillary Nerve; Musculocutaneous Nerve; Peripheral Nerve Function

Outcome Measures

Primary Outcomes (3)

• Change in CMAP Amplitude of Axillary and Musculocutaneous Nerves

  Compound muscle action potential (CMAP) amplitude measured using nerve conduction studies (NCS).

  Preoperative baseline and 12 weeks after surgery

• Change in Distal Motor Latency

  Distal motor latency measured using nerve conduction studies (NCS).

  Preoperative baseline and 12 weeks after surgery

• Change in Nerve Conduction Velocity

  Motor nerve conduction velocity measured using nerve conduction studies (NCS).

  Preoperative baseline and 12 weeks after surgery

Secondary Outcomes (2)

• Shoulder Range of Motion (ROM)

  Preoperative baseline and 12 weeks after surgery

• Pain Level (VAS)

  Preoperative baseline and 12 weeks after surgery

Study Arms (1)

Frozen Shoulder Patients Undergoing Arthroscopic 360° Capsular Release

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

Interventions

Arthroscopic 360° Capsular Release PROCEDURE

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.

Frozen Shoulder Patients Undergoing Arthroscopic 360° Capsular Release

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Known peripheral neuropathy
• Previous brachial plexus injury
• History of ipsilateral shoulder neurovascular surgery
• Previous proximal brachial plexus surgery
• Coagulation disorders
• Active infection
• Pregnancy

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Nezih Ziroglu, MD

  Acıbadem Mehmet Ali Aydınlar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nezih Ziroglu, MD

CONTACT

+90 505 631 6484; nezih.ziroglu@yahoo.com

Mehmet Oğuz Çolak, MD

CONTACT

+90 544 401 7600; oguzcolak22@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)