- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03556449
High Resolution Ultrasound of Scapulae Alatae - a Prospective Case Control Study
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Aarhus, Denmark, 8000
- Clinic of Neurophysiology, the department of Neurology, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients
High resolution ultrasound
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Using a high-frequency linear array transducer (18L6 HD)
Other Names:
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Healthy subjects
High resolution ultrasound
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Using a high-frequency linear array transducer (18L6 HD)
Other Names:
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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
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Thickness of musculus trapezius
Time Frame: 10-15 minuttes
|
10-15 minuttes
|
Thickness of musculus rhomboideus
Time Frame: 10-15 minuttes
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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