Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Not Applicable

Completed

• Conditions: Tendinopathy; Rotator Cuff Tendinitis; Elasticity Imaging Techniques; Musculoskeletal Disease
• Interventions: Diagnostic Test: Diagnostic

• Registration Number: NCT03425344
• Lead Sponsor: Karen Brage

Brief Summary

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 Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-03-11
• Primary Completion: 2019-07-01
• Status Verified: 2019-08
• 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: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic	Diagnostic	All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.

Primary Outcome Measures

Name	Time	Method
Tendon quality (SEL)	Baseline	Sonoelastography - strain elasticity

Secondary Outcome Measures

Name	Time	Method
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.
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).
Tendon quality (US)	Baseline	Conventional ultrasound
Tendon quality (MRI)	Baseline	Magnetic Resonance

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark