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CompletedNCT03556449Updated Jan 14, 2021

High Resolution Ultrasound of Scapulae Alatae - a Prospective Case Control Study

An observational study in Scapula Alata and Scapular Winging, sponsored by Sándor Beniczky. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Sándor Beniczky · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Scapula Alata
  • Scapular Winging

Keywords

  • scapula/innervation*
  • Thoracic Nerves/injuries*
  • Peripheral Nerve Injuries
  • Shoulder
  • Musculoskeletal Diseases/diagnosis*
03

In context

Lead sponsor

Sándor Beniczky is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

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/.

Eligibility criteria

Patients:

Inclusion Criteria:

  • Clinical suspicion of scapula alata

Exclusion Criteria:

  • Winged scapula due to other cause than nerve damage. eg. myopathy

Healthy subjects

Exclusion Criteria:

  • History of Shoulder trauma or shoulder disease
  • History of cervical radiculopathy
  • History of upper extremity peripheral neuropathy/plexopathy
  • Peripheral vascular disease
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    High resolution ultrasound

    Diagnostic Test: High resolution ultrasound

  • Healthy subjects

    High resolution ultrasound

    Diagnostic Test: High resolution ultrasound

Interventions

  • Diagnostic testHigh resolution ultrasound

    Using a high-frequency linear array transducer (18L6 HD)

    Also known as: Siemens ACUSON S1000

06

What researchers measure

Primary outcomes

  1. Thickness of musculus serratus anterior

    Time frame: 10-15 minuttes

  2. Thickness of musculus trapezius

    Time frame: 10-15 minuttes

  3. Thickness of musculus rhomboideus

    Time frame: 10-15 minuttes

  4. Cross sectional area of nervus thoracicus longus

    Time frame: 10-15 minuttes

  5. Cross sectional area of nervus accesorius

    Time frame: 10-15 minuttes

  6. Cross sectional area of nervus dorsalis scapularis

    Time frame: 10-15 minuttes

07

Study locations

1 site
  • Clinic of Neurophysiology, the department of Neurology, Aarhus University Hospital
    Aarhus, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03556449
Lead sponsor
Sándor Beniczky
Responsible party
Sándor Beniczky (Professor, Aarhus University Hospital) — Sponsor-investigator
First posted
Jun 14, 2018
Start date
Apr 12, 2018
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
Jan 14, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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