Soft Tissue Shoulder InjuryNCT02644564
Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
An observational study of Soft Tissue Shoulder Injury and Rotator Cuff Tear, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Soft Tissue Shoulder Injury, Rotator Cuff Tear
- What is being tested?
- Ultrasonography
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 5 Oct 2015to 16 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Section for Orthopaedic Emergency, Orthopaedic department, Oslo University Hospital
Oslo, 0182
About this study
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
- Being tested
- Ultrasonography
- Keywords
- Soft tissue shoulder injury, Rotator cuff tear, Ultrasonography
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 21 days of acute shoulder injury
Secondary outcomes (2)
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.
Measured: 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
Measured: Within one year of shoulder injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start5 Oct 2015
- Primary completion17 Oct 2016
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martine Enger, Oslo University Hospital
- Investigators
- Jens Ivar Brox, MD PhD, Study chair, Oslo University Hosital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644564
- Sponsor's protocol ID
- 2015/195
- Status last verified
- Oct 2017
- First submitted
- 31 Dec 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40462009
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
- ClinicalTrials.gov ID
- NCT02644564
- Acronym / sponsor ID
- 2015/195
- Conditions
- Soft Tissue Shoulder Injury, Rotator Cuff Tear
- Keywords
- Soft tissue shoulder injury, Rotator cuff tear, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 17 Oct 2016 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography | – | Other: UltrasonographyPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyOne 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. | Other | Ultrasonography |
Primary outcome
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
2 secondary outcomes
Oxford Shoulder Score (OSS)
Time frame: Within one year of shoulder injury
Shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
Time frame: Within one year of shoulder injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Derived from this study: PubMed 40462009Enger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Ivar Brox, MD PhD study chair
Oslo University Hosital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Shoulder Injury and Rotator Cuff Tear, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of full-thickness rotator cuff tear (time frame: Within 21 days of acute shoulder injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.