Adhesive CapsulitisFROZEN-EMGNCT07495306
Electrophysiologic Changes After Extended 360° Capsular Release
An observational study of Adhesive Capsulitis and Frozen Shoulder, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- Arthroscopic 360° Capsular Release
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2026to 14 Mar 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Known peripheral neuropathy
- Previous brachial plexus injury
- History of ipsilateral shoulder neurovascular surgery
- Previous proximal brachial plexus surgery
- Coagulation disorders
- Active infection
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Mehmet Ali Aydinlar University Hospital
Istanbul, Istanbul, 34752
Nezih Ziroglu, MD, +90 505 631 6484, nezih.ziroglu@yahoo.com
Mehmet Oğuz Çolak, MD, +90 544 401 7600, oguzcolak22@gmail.com
About this study
Official title: Electrophysiological Evidence of Neural Function Improvement After Extended Arthroscopic Circumferential Capsular Release for Adhesive Capsulitis
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.
Read more
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.
Read the detailed description
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
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- Arthroscopic 360° Capsular Release
- Keywords
- Adhesive Capsulitis, 360° Capsular Release, Shoulder Arthroscopy, Electromyography, Axillary Nerve, Musculocutaneous Nerve, Peripheral Nerve Function
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic 360° Capsular ReleaseProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Arthroscopic 360° Capsular Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CMAP Amplitude of Axillary and Musculocutaneous Nerves
Compound muscle action potential (CMAP) amplitude measured using nerve conduction studies (NCS).
Measured: Preoperative baseline and 12 weeks after surgery
Change in Distal Motor Latency
Distal motor latency measured using nerve conduction studies (NCS).
Measured: Preoperative baseline and 12 weeks after surgery
Change in Nerve Conduction Velocity
Motor nerve conduction velocity measured using nerve conduction studies (NCS).
Measured: Preoperative baseline and 12 weeks after surgery
Secondary outcomes (2)
Shoulder Range of Motion (ROM)
Active and passive shoulder range of motion measured using standard goniometric evaluation.
Measured: 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.
Measured: Preoperative baseline and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start26 Feb 2026
- Primary completion26 Feb 2027 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nezih Ziroglu, MD, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495306
- Sponsor's protocol ID
- ACU-ORT- 2026-03/34
- Acronym
- FROZEN-EMG
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Evidence of Neural Function Improvement After Extended Arthroscopic Circumferential Capsular Release for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07495306
- Acronym / sponsor ID
- FROZEN-EMG / ACU-ORT- 2026-03/34
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Keywords
- Adhesive Capsulitis, 360° Capsular Release, Shoulder Arthroscopy, Electromyography, Axillary Nerve, Musculocutaneous Nerve, Peripheral Nerve Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 14 Mar 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frozen Shoulder Patients Undergoing Arthroscopic 360° Capsular Release | – | Procedure: Arthroscopic 360° Capsular ReleaseThis 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Known peripheral neuropathy
- Previous brachial plexus injury
- History of ipsilateral shoulder neurovascular surgery
- Previous proximal brachial plexus surgery
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic 360° Capsular ReleaseArthroscopic 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. | Procedure or surgery | Frozen Shoulder Patients Undergoing Arthroscopic 360° Capsular Release |
Primary outcome
Change in CMAP Amplitude of Axillary and Musculocutaneous Nerves
Time frame: Preoperative baseline and 12 weeks after surgery
Compound muscle action potential (CMAP) amplitude measured using nerve conduction studies (NCS).
Change in Distal Motor Latency
Time frame: Preoperative baseline and 12 weeks after surgery
Distal motor latency measured using nerve conduction studies (NCS).
Change in Nerve Conduction Velocity
Time frame: Preoperative baseline and 12 weeks after surgery
Motor nerve conduction velocity measured using nerve conduction studies (NCS).
2 secondary outcomes
Shoulder Range of Motion (ROM)
Time frame: Preoperative baseline and 12 weeks after surgery
Pain Level (VAS)
Time frame: Preoperative baseline and 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nezih Ziroglu, MD principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis and Frozen Shoulder, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nezih Ziroglu, MD (+90 505 631 6484, nezih.ziroglu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CMAP Amplitude of Axillary and Musculocutaneous Nerves (time frame: Preoperative baseline and 12 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.