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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear; Soft Tissue Shoulder Injury
• Intervention / Treatment: Other: Ultrasonography

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0182
    • Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Ultrasonography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of full-thickness rotator cuff tear	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	Within 21 days of acute shoulder injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score (OSS)	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.	Within one year of shoulder injury
Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)	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	Within one year of shoulder injury

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Jens Ivar Brox, MD PhD, Oslo University Hosital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): October 17, 2016
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: December 31, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasonography; Rotator cuff tear; Soft tissue shoulder injury
• Additional Relevant MeSH Terms: Rupture; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: 2015/195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED