Elasticity Imaging TechniquesNCT03425344
Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
A study testing Diagnostic in people with Elasticity Imaging Techniques and Tendinopathy, run by Karen Brage at 1 site in Denmark.
Trial summary
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis
- What is being tested?
- Diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2018to 21 Aug 2019
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index < 30
- Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
- Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).
Who cannot join
- Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (> 1/3 of the vertical tendon height) and calcifications (> 2 mm in length) (MRI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy
Read the detailed description
The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.
In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.
Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.
- Conditions
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
- Being tested
- Diagnostic
- Medical subject headings
- Tendinopathy, Rotator Cuff Injuries, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticDiagnostic test
No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Other | All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography. Receives: Diagnostic Test: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon quality (SEL)
Sonoelastography - strain elasticity
Measured: Baseline
Secondary outcomes (5)
Pain on a VAS scale
Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
Measured: Baseline
Quality of life on the E!-5D-3L questionnaire
Change in Euro Qol 5D index (EQ-5D-3L). The system consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 levels; no problems, some problems and extreme problems. The EQ-VAS range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline
Disability
Change in Disability of the Arm, Shoulder and Hand questionnaire (DASH). Each item is rated with a score from 1 (least disability) to 5 (most disability). All scores are added together, producing a raw score, which is then transformed into a score of 100 maximum. A higher score indicates greater disability.
Measured: Baseline
Tendon quality (MRI)
Magnetic Resonance
Measured: Baseline
Tendon quality (US)
Conventional ultrasound
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start11 Mar 2018
- Primary completion1 Jul 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elasticity Imaging TechniquesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A case-control study without intervention
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Brage
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
- Responsible party
- Sponsor-investigator, Karen Brage, University of Southern Denmark
- Investigators
- Birgit Juul-Kristensen, Assoc. Prof, Study director, Department of Sport Science and Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425344
- Sponsor's protocol ID
- SEL_Supraspinatus_cross
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03425344
- Acronym / sponsor ID
- SEL_Supraspinatus_cross
- Conditions
- Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karen BrageUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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.
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy
Detailed description
The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.
In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.
Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A case-control study without intervention
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Other | Diagnostic Test: DiagnosticAll participants will be exposed to shoulder- MRI, ultrasound and sonoelastography. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index < 30
- Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
- Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).
Key exclusion criteria (1 listed)
- Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (> 1/3 of the vertical tendon height) and calcifications (> 2 mm in length) (MRI).
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 |
|---|---|---|
| DiagnosticNo traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.. | Diagnostic test | Diagnostic |
Primary outcome
Tendon quality (SEL)
Time frame: Baseline
Sonoelastography - strain elasticity
5 secondary outcomes
Pain on a VAS scale
Time frame: Baseline
Quality of life on the E!-5D-3L questionnaire
Time frame: Baseline
Disability
Time frame: Baseline
Tendon quality (MRI)
Time frame: Baseline
Tendon quality (US)
Time frame: Baseline
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 22 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Birgit Juul-Kristensen, Assoc. Prof study director
Department of Sport Science and Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic in people with Elasticity Imaging Techniques and Tendinopathy, run by Karen Brage at 1 site in Denmark.
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 3 inclusion and 1 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 22 Aug 2019. 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 Denmark. 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?
Tendon quality (SEL) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2019.