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

NCT02644564 | Completed

• 1 other identifier: 2015/195
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Shoulder Injury; Rotator Cuff Tear

Keywords

Soft tissue shoulder injury; Rotator cuff tear; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

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

Interventions

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.

Ultrasonography

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital

Oslo, 0182, Norway

Location

Related Publications (1)

• Enger M, Schmidt M, Nordsletten L, Moosmayer S, Pripp AH, Melhuus K, Brox JI. Physical examination tests in the acute phase of shoulder injuries with negative radiographs: a diagnostic accuracy study. BMC Musculoskelet Disord. 2025 Jun 3;26(1):546. doi: 10.1186/s12891-025-08754-1.

  PMID: 40462009 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jens Ivar Brox, MD PhD

  Oslo University Hosital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 1, 2016
• Study Start: October 5, 2015
• Primary Completion: October 17, 2016
• Study Completion: October 16, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

NO (1)