Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Karen Brage60 enrolled

Overview

This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Elasticity Imaging Techniques Tendinopathy Rotator Cuff Tendinitis Musculoskeletal Disease

Interventions

DiagnosticDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

University of Southern Denmark

Odense, Denmark

Outcomes

Primary Outcomes

Tendon quality (SEL)

Sonoelastography - strain elasticity

Time frame: Baseline

Secondary Outcomes

Pain on a VAS scale

Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.

Time frame: Baseline

Quality of life on the E!-5D-3L questionnaire

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).

Time frame: Baseline

Disability

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.

Time frame: Baseline

Tendon quality (MRI)

Magnetic Resonance

Time frame: Baseline

Tendon quality (US)

Conventional ultrasound

Time frame: Baseline

Data from ClinicalTrials.gov

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