Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
Study Details
Study Description
Brief Summary
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Diagnostic All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography. |
Diagnostic Test: Diagnostic
No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
|
Outcome Measures
Primary Outcome Measures
- Tendon quality (SEL) [Baseline]
Sonoelastography - strain elasticity
Secondary Outcome Measures
- Pain on a VAS scale [Baseline]
Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.
- Quality of life on the E!-5D-3L questionnaire [Baseline]
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).
- Disability [Baseline]
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.
- Tendon quality (MRI) [Baseline]
Magnetic Resonance
- Tendon quality (US) [Baseline]
Conventional ultrasound
Other Outcome Measures
- Demographic [Baseline]
Gender, age, bmi, education (level), duration of symptoms, symptom history
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern Denmark | Odense | Denmark | 5230 |
Sponsors and Collaborators
- Karen Brage
- Odense University Hospital
- Sygehus Lillebaelt
- Gigtforeningen
- Region of Southern Denmark
- Radiograf Rådet
Investigators
- Study Director: Birgit Juul-Kristensen, Assoc. Prof, Department of Sport Science and Biomechanics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEL_Supraspinatus_cross