Sonoelastography of the Supraspinatus Tendon

Study Overview
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Brief Summary
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This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.

Detailed Description
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The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark. The intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals. Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline

Official Title
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Responsiveness of Sonoelastography in the Supraspinatus Tendon

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

Intervention / Treatment
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* Other: Low Load Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and understand Danish Shoulder pain > 3 months Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking) Tendinopathy (MRI) Exclusion Criteria: BMI > 30 Bilateral shoulder pain Supraspinatus full thickness rupture (US) Biceps rupture (US) Calcification in supraspinatus (X-ray) Pregnancy Glenohumeral arthrosis (X-ray) Frozen shoulder Shoulder symptoms originating from neck Shoulder fracture, operation or luxation Known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondylarthropathy or psychiatric disorders Labrum lesion (MRI) Tear (˃1/3 of supraspinatus, vertical height) (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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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Load Exercises<br>An exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction. | Other: Low Load Exercises<br>* All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps). The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).<br>* Other names: Strength training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon quality (SEL) | Change from baseline in tendon quality (sonoelastography - strain elasticity) | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon quality (MRI) | Change from baseline in tendon quality (MRI) | Baseline and 12 weeks | 
| Tendon quality (US) | Change from baseline in tendon quality (conventional ultrasound) | Baseline and 12 weeks | 
| Strength | Change from baseline in Isometric Strength (MVC) | Baseline and 12 weeks | 
| Recovery | Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement. | 12 weeks | 
| Pain | Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain. | Baseline and 12 weeks |