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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644564
• Other study ID #: 2015/195
• Status: Completed
• Phase: N/A
• First received: December 31, 2015
• Last updated: October 31, 2017
• Start date: October 5, 2015
• Est. completion date: October 16, 2017

Study information

• Verified date: October 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 16, 2017
• Est. primary completion date: October 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Injuries
• Soft Tissue Shoulder Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Norway	Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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