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

NCT03556449 | Completed DMC

• 3 other identifiers: USSA35321-10-72-152-18
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Scapula Alata; Scapular Winging

Keywords

scapula/innervation*; Thoracic Nerves/injuries*; Peripheral Nerve Injuries; Shoulder; Musculoskeletal Diseases/diagnosis*

Outcome Measures

Primary Outcomes (6)

• Thickness of musculus serratus anterior

  10-15 minuttes

• Thickness of musculus trapezius

  10-15 minuttes

• Thickness of musculus rhomboideus

  10-15 minuttes

• Cross sectional area of nervus thoracicus longus

  10-15 minuttes

• Cross sectional area of nervus accesorius

  10-15 minuttes

• Cross sectional area of nervus dorsalis scapularis

  10-15 minuttes

Study Arms (2)

Patients

High resolution ultrasound

Diagnostic Test: High resolution ultrasound

Healthy subjects

High resolution ultrasound

Diagnostic Test: High resolution ultrasound

Interventions

High resolution ultrasound DIAGNOSTIC_TEST

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

Also known as: Siemens ACUSON S1000

Healthy subjects; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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/.

You may qualify if:

• Clinical suspicion of scapula alata

You may not qualify if:

• 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

Sponsors & Collaborators

• Sándor Beniczky: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Wounds and Injuries; Peripheral Nerve Injuries; Musculoskeletal Diseases; Disease

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 14, 2018
• Study Start: April 12, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: January 14, 2021

Record last verified: 2018-06

Locations

DK (1)