Scapula AlataNCT03556449
High Resolution Ultrasound of Scapulae Alatae - a Prospective Case Control Study
An observational study of Scapula Alata and Scapular Winging, run by Sándor Beniczky at 1 site in Denmark.
Trial summary
Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scapula Alata, Scapular Winging
- What is being tested?
- High resolution ultrasound
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2018to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients: From patients referred to the department of Neurophysiology, Aarhus University hopsital. Healthy subjects: From recruitment posters at Aarhus University, Aarhus University Hospital and at http://www.forsoegsperson.dk/.
Who may be able to join
- Clinical suspicion of scapula alata
Who cannot join
- Winged scapula due to other cause than nerve damage. eg. myopathy
- Healthy subjects
- History of Shoulder trauma or shoulder disease
- History of cervical radiculopathy
- History of upper extremity peripheral neuropathy/plexopathy
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinic of Neurophysiology, the department of Neurology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: High Resolution Ultrasound of Scapulae Alatae - Correlation With Electrophysiological Measurements - a Prospective Case Control Study
Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Unrecognized and misdiagnosed scapula alata and, consequently, wrong or delayed treatment is a general problem in this patient group. Today the diagnosis is based on the clinical examination and the electrophysiological examination. One of the problems is that the electrophysiological examination in a fair part of the patients is not showing any pathology even though the history of the patient and the clinical evaluation are indicating scapula alata.
This study is a single-blinded, prospective, controlled multicentre study. The aim of the study is to investigate whether ultrasound can be used as a supplement to the electrophysiological examination when diagnosing scapula alata. Ultrasound will be used to visualize possible thickening of the cross-sectional area of nerves and the degree and pattern of muscle involvement in patients with scapula alata. By comparing measurements from scapula alata patients with the measurements from healthy controls, we are able to see if ultrasound can distinguish these two groups from each other. Furthermore, we will examine whether the ultrasound measurements correlate with the electrophysiological findings in patients and, when available, compare the ultrasound measurements of muscle thickness with MRI (magnetic resonance Imaging) findings. The use of ultrasound in scapula alata patients may help determine the presence and severity of a nerve lesion and the subsequent degree of muscle involvement and may therefore serve as a supplement to the clinical diagnosis.
- Conditions
- Scapula Alata, Scapular Winging
- Being tested
- High resolution ultrasound
- Keywords
- scapula/innervation*, Thoracic Nerves/injuries*, Peripheral Nerve Injuries, Shoulder, Musculoskeletal Diseases/diagnosis*
- Medical subject headings
- Wounds and Injuries, Peripheral Nerve Injuries, Musculoskeletal Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution ultrasoundDiagnostic test
Also called Siemens ACUSON S1000
Using a high-frequency linear array transducer (18L6 HD)
| Study group | Role | What they receive |
|---|---|---|
| Patients | High resolution ultrasound Receives: Diagnostic Test: High resolution ultrasound | |
| Healthy subjects | High resolution ultrasound Receives: Diagnostic Test: High resolution ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of musculus serratus anterior
Measured: 10-15 minuttes
Thickness of musculus trapezius
Measured: 10-15 minuttes
Thickness of musculus rhomboideus
Measured: 10-15 minuttes
Cross sectional area of nervus thoracicus longus
Measured: 10-15 minuttes
Cross sectional area of nervus accesorius
Measured: 10-15 minuttes
Cross sectional area of nervus dorsalis scapularis
Measured: 10-15 minuttes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start12 Apr 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapula AlataStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sándor Beniczky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sándor Beniczky, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556449
- Sponsor's protocol ID
- USSA
- Other IDs
- 3532, 1-10-72-152-18
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Ultrasound of Scapulae Alatae - Correlation With Electrophysiological Measurements - a Prospective Case Control Study
- ClinicalTrials.gov ID
- NCT03556449
- Acronym / sponsor ID
- USSA
- Conditions
- Scapula Alata, Scapular Winging
- Keywords
- scapula/innervation*, Thoracic Nerves/injuries*, Peripheral Nerve Injuries, Shoulder, Musculoskeletal Diseases/diagnosis*
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sándor BeniczkyUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 14 Jun 2018 (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.
Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Unrecognized and misdiagnosed scapula alata and, consequently, wrong or delayed treatment is a general problem in this patient group. Today the diagnosis is based on the clinical examination and the electrophysiological examination. One of the problems is that the electrophysiological examination in a fair part of the patients is not showing any pathology even though the history of the patient and the clinical evaluation are indicating scapula alata.
This study is a single-blinded, prospective, controlled multicentre study. The aim of the study is to investigate whether ultrasound can be used as a supplement to the electrophysiological examination when diagnosing scapula alata. Ultrasound will be used to visualize possible thickening of the cross-sectional area of nerves and the degree and pattern of muscle involvement in patients with scapula alata. By comparing measurements from scapula alata patients with the measurements from healthy controls, we are able to see if ultrasound can distinguish these two groups from each other. Furthermore, we will examine whether the ultrasound measurements correlate with the electrophysiological findings in patients and, when available, compare the ultrasound measurements of muscle thickness with MRI (magnetic resonance Imaging) findings. The use of ultrasound in scapula alata patients may help determine the presence and severity of a nerve lesion and the subsequent degree of muscle involvement and may therefore serve as a supplement to the clinical diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: High resolution ultrasoundHigh resolution ultrasound |
| Healthy subjects | – | Diagnostic Test: High resolution ultrasoundHigh resolution ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients: From patients referred to the department of Neurophysiology, Aarhus University hopsital. Healthy subjects: From recruitment posters at Aarhus University, Aarhus University Hospital and at http://www.forsoegsperson.dk/.
Key inclusion criteria (1 listed)
- Clinical suspicion of scapula alata
Key exclusion criteria (6 listed)
- Winged scapula due to other cause than nerve damage. eg. myopathy
- Healthy subjects
- History of Shoulder trauma or shoulder disease
- History of cervical radiculopathy
- History of upper extremity peripheral neuropathy/plexopathy
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 |
|---|---|---|
| High resolution ultrasoundAlso: Siemens ACUSON S1000Using a high-frequency linear array transducer (18L6 HD) | Diagnostic test | Healthy subjects, Patients |
Primary outcome
Thickness of musculus serratus anterior
Time frame: 10-15 minuttes
Thickness of musculus trapezius
Time frame: 10-15 minuttes
Thickness of musculus rhomboideus
Time frame: 10-15 minuttes
Cross sectional area of nervus thoracicus longus
Time frame: 10-15 minuttes
Cross sectional area of nervus accesorius
Time frame: 10-15 minuttes
Cross sectional area of nervus dorsalis scapularis
Time frame: 10-15 minuttes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Scapula Alata and Scapular Winging, run by Sándor Beniczky at 1 site in Denmark.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jan 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of musculus serratus anterior (time frame: 10-15 minuttes). The study lists 6 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 14 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.