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

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.

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Key information

Conditions

Soft Tissue Shoulder Injury Rotator Cuff Injuries Rotator Cuff Tear Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital

Oslo, 0182, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography

Other

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.

Primary outcomes

Detection of full-thickness rotator cuff tear

Time frame: Within 21 days of acute shoulder injury

To 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 outcomes

Oxford Shoulder Score (OSS)

Time frame: Within one year of shoulder injury

The 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)

Time frame: Within one year of shoulder injury

QuickDASH 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Jan 1, 2016
Registry last updated: Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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