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

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ClinicalTrials.gov Identifier: NCT03556449
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

Brief 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.


Condition or disease Intervention/treatment
Scapula Alata Scapular Winging Diagnostic Test: High resolution ultrasound

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: High Resolution Ultrasound of Scapulae Alatae - Correlation With Electrophysiological Measurements - a Prospective Case Control Study
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Patients
High resolution ultrasound
Diagnostic Test: High resolution ultrasound
Using a high-frequency linear array transducer (18L6 HD)
Other Name: Siemens ACUSON S1000

Healthy subjects
High resolution ultrasound
Diagnostic Test: High resolution ultrasound
Using a high-frequency linear array transducer (18L6 HD)
Other Name: Siemens ACUSON S1000




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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/.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556449


Contacts
Contact: Sara S Bak 0045 23934785 sarbak@rm.dk

Locations
Denmark
Clinic of Neurophysiology, the department of Neurology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Sara S Bak    0045 2393 4785    sarbak@rm.dk   
Sponsors and Collaborators
Sándor Beniczky

Responsible Party: Sándor Beniczky, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03556449     History of Changes
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 )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sándor Beniczky, Aarhus University Hospital:
scapula/innervation*
Thoracic Nerves/injuries*
Peripheral Nerve Injuries
Shoulder
Musculoskeletal Diseases/diagnosis*