Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Study Overview
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Brief Summary
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This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy

Detailed Description
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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.

Official Title
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Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers

Conditions
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Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease

Intervention / Treatment
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* Diagnostic Test: Diagnostic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A case-control study without intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic<br>All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography. | Diagnostic Test: Diagnostic<br>* No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon quality (SEL) | Sonoelastography - strain elasticity | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | Baseline | 
| Tendon quality (MRI) | Magnetic Resonance | Baseline | 
| Tendon quality (US) | Conventional ultrasound | Baseline |