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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02644564
Enrollment
120
Registered
2016-01-01
Start date
2015-10-05
Completion date
2017-10-16
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear, Soft Tissue Shoulder Injury

Keywords

Soft tissue shoulder injury, Rotator cuff tear, Ultrasonography

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.

Interventions

OTHERUltrasonography

One doctor does the clinical examination, another does ultrasonography. Both doctors and patient are blinded until results have been registered on written forms. The results are then disclosed to the patient and doctors in order to plan further treatment.

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of full-thickness rotator cuff tearWithin 21 days of acute shoulder injuryTo explore the number of acute traumatic full-thickness tears in soft tissue injuries in the ≥ 40 population, and whether structured clinical examination is an adequate screening tool

Secondary

MeasureTime frameDescription
Oxford Shoulder Score (OSS)Within one year of shoulder injuryThe OSS is a patient reported outcome score consisting of 12 items. It was developed for use in assessing the outcome of shoulder surgery, but is also used to assess non-surgical interventions. Each item is scored from 0 to 4, and the overall scores ranges from 0 to 48. The request for a licence to use the score was approved by Isis Outcomes on July 2nd 2015.
Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)Within one year of shoulder injuryQuickDASH is a patient reported outcome score consisting 11 of the original 30 items of the disabilities of the arm, shoulder and hand (DASH) questionnaire. Each item has five options, and the total score ranges from 0 - 100. The Norwegian translation used in the study is available at http://dash.iwh.on.ca/system/files/translations/QuickDASH\_Norwegian.pdf

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026