Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-11

Study Completion Date

2019-08-21

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

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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.

Conditions

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Elasticity Imaging Techniques Tendinopathy Rotator Cuff Tendinitis Musculoskeletal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A case-control study without intervention

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic

All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.

Group Type OTHER

Diagnostic

Intervention Type DIAGNOSTIC_TEST

No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..

Interventions

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Diagnostic

No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..

Intervention Type DIAGNOSTIC_TEST

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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes