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NCT Number: NCT03556449

High Resolution Ultrasound of Scapulae Alatae - 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Neurophysiology, the department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High resolution ultrasound

Diagnostic Test

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

Other names: Siemens ACUSON S1000

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

Sponsors and collaborators

Lead sponsor

Sándor Beniczky

Other

Registry information

Official study title

High Resolution Ultrasound of Scapulae Alatae - Correlation With Electrophysiological Measurements - a Prospective Case Control Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2018
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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