Sonoelastography of the Supraspinatus Tendon

Not Applicable

Completed

• Conditions: Elasticity Imaging Techniques; Tendinopathy; Rotator Cuff Tendinitis; Musculoskeletal Disease
• Interventions: Other: Low Load Exercises

• Registration Number: NCT03425357
• Lead Sponsor: Karen Brage

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-03-25
• Status Verified: 2019-08
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-21
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Load Exercises	Low Load Exercises	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.

Primary Outcome Measures

Name	Time	Method
Tendon quality (SEL)	Baseline and 12 weeks	Change from baseline in tendon quality (sonoelastography - strain elasticity)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark