Electrophysiologic Changes After Extended 360° Capsular Release

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-70
SponsorAcibadem University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known peripheral neuropathy

Previous brachial plexus injury

History of ipsilateral shoulder neurovascular surgery

Previous proximal brachial plexus surgery

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Arthroscopic 360° Capsular Release

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Frozen Shoulder Patients Undergoing Arthroscopic 360° Capsular Release1 intervention

Trial outcomes

Primary outcomes

1

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
2

Change in Distal Motor Latency

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

Time frame
Preoperative baseline and 12 weeks after surgery
3

Change in Nerve Conduction Velocity

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

Time frame
Preoperative baseline and 12 weeks after surgery

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.