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

January 13, 2021 updated by: Sándor Beniczky

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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/.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
High resolution ultrasound
Using a high-frequency linear array transducer (18L6 HD)
Other Names:
  • Siemens ACUSON S1000
Healthy subjects
High resolution ultrasound
Using a high-frequency linear array transducer (18L6 HD)
Other Names:
  • Siemens ACUSON S1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thickness of musculus serratus anterior
Time Frame: 10-15 minuttes
10-15 minuttes
Thickness of musculus trapezius
Time Frame: 10-15 minuttes
10-15 minuttes
Thickness of musculus rhomboideus
Time Frame: 10-15 minuttes
10-15 minuttes
Cross sectional area of nervus thoracicus longus
Time Frame: 10-15 minuttes
10-15 minuttes
Cross sectional area of nervus accesorius
Time Frame: 10-15 minuttes
10-15 minuttes
Cross sectional area of nervus dorsalis scapularis
Time Frame: 10-15 minuttes
10-15 minuttes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • USSA
  • 3532 (Other Grant/Funding Number: The Lundbeck Foundation)
  • 1-10-72-152-18 (Other Identifier: The regional Committee on Health Research Ethics, Denmark)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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