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

Completed

• Conditions: Rotator Cuff Tear; Soft Tissue Shoulder Injury
• Interventions: Other: Ultrasonography

• Registration Number: NCT02644564
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Study First Submitted: 2015-12-31
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Primary Completion: 2016-10-17
• Status Verified: 2017-10
• Study Completion: 2017-10-16
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasonography	Ultrasonography	Patients will undergo structured clinical examination and ultrasonography of both shoulders on the day of inclusion. They also fill out an injury registration form, Oxford Shoulder Score and QuickDASH. Follow-up at 3, 6 and 12 months will be identical, but without ultrasonography and injury registration form.

Primary Outcome Measures

Name	Time	Method
Detection of full-thickness rotator cuff tear	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 Outcome Measures

Name	Time	Method
Oxford Shoulder Score (OSS)	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)	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

Trial Locations

Locations (1)

Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital; 🇳🇴 Oslo, Norway