Clinical trial NCT02644564: Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
Official title: Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Shoulder Injury
Rotator Cuff Tear
Keywords: Soft tissue shoulder injury
Rotator cuff tear
Ultrasonography
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients living in the municipality of Oslo that visit Section for Orthopaedic Emergency (Oslo skadelegevakt), Oslo University Hospital with an acute shoulder injury.

Brief summary: The purpose of the study is to determine whether the introduction of early ultrasonography screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients aged forty years or more. We also want to study whether certain physical tests will be able to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over a year, as well as to compare the results to studies on the prevalence of rotator cuff full-thickness tears.


Eligibility 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

Primary outcomes:
measure: Detection of full-thickness rotator cuff tear
timeFrame: Within 21 days of acute shoulder injury
Secondary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: Within one year of shoulder injury
measure: Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
timeFrame: Within one year of shoulder injury
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital
Study officials:
affiliation: Oslo University Hosital
name: Jens Ivar Brox, MD PhD
role: STUDY_CHAIR
References: