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

NCT ID: NCT03556449

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-12

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scapula Alata Scapular Winging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

High resolution ultrasound

High resolution ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Healthy subjects

High resolution ultrasound

High resolution ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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High resolution ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Siemens ACUSON S1000

Eligibility Criteria

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Inclusion Criteria

* Clinical suspicion of scapula alata

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sándor Beniczky

OTHER

Sponsor Role lead

Responsible Party

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Sándor Beniczky

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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3532

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1-10-72-152-18

Identifier Type: OTHER

Identifier Source: secondary_id

USSA

Identifier Type: -

Identifier Source: org_study_id

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