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Clinical Trials/NCT02644564
NCT02644564
Completed
Not Applicable

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

Oslo University Hospital1 site in 1 country120 target enrollmentOctober 5, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Soft Tissue Shoulder Injury
Sponsor
Oslo University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Detection of full-thickness rotator cuff tear
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2015
End Date
October 16, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Martine Enger

MD

Oslo University Hospital

Eligibility Criteria

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

Outcomes

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)(Within one year of shoulder injury)
  • Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)(Within one year of shoulder injury)

Study Sites (1)

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