Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02644564
• Date of registration: 31/12/2015
• Prospective Registration: No
• Primary sponsor: Oslo University Hospital
• Public title: Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
• Scientific title: Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
• Date of first enrolment: October 5, 2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02644564
• Study type: Observational
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Jens Ivar Brox, MD PhD
• Affiliation: Oslo University Hosital

Key inclusion & exclusion criteria

Inclusion Criteria, all of the following:

- patient at Section for Orthopaedic Emergency, Oslo University Hospital

- living in the municipality of Oslo

- acute injury

- sudden onset of symptoms

- International Classification of Diseases (ICD) -10 S4-diagnosis (except injuries of
middle and distal third of humerus and related soft tissue)

- no sign of acute injury on radiographs in two views, or successfully reduced
dislocation without fracture

- turns up for follow-up appointment within 21 days of injury

Exclusion Criteria:

- patients that are incapable of giving and or receiving adequate information, or that
cannot undergo a normal clinical investigation, due to for example language problems,
level of consciousness, drugs, mental or emotional status or other

- patients that have undergone shoulder surgery during the last 6 months

- injury of both shoulders

- patients with neck-/shoulder problems or generalised muscle pain during the last three
months before the injury

- other serious disease such as cancer, rheumatic disorders, haematological,
neurological, endocrinological or gastrointestinal disease that according to the
doctor`s best clinical judgement makes participation or follow-up difficult

- does not want to participate



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Soft Tissue Shoulder Injury

Rotator Cuff Tear

Intervention(s)

Other: Ultrasonography

Primary Outcome(s)

Detection of full-thickness rotator cuff tear [Time Frame: Within 21 days of acute shoulder injury]

Secondary Outcome(s)

Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) [Time Frame: Within one year of shoulder injury]

Oxford Shoulder Score (OSS) [Time Frame: Within one year of shoulder injury]

Secondary ID(s)

2015/195

Source(s) of Monetary Support

Please refer to primary and secondary sponsors