ClinicalTrials.Veeva

Menu

Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

K

Karen Brage

Status

Completed

Conditions

Elasticity Imaging Techniques
Rotator Cuff Tendinitis
Musculoskeletal Disease
Tendinopathy

Treatments

Diagnostic Test: Diagnostic

Study type

Interventional

Funder types

Other

Identifiers

NCT03425344
SEL_Supraspinatus_cross

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Diagnostic
Other group
Description:
All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.
Treatment:
Diagnostic Test: Diagnostic

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems