Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03425344

Enrollment

Registered

2018-02-07

Start date

2018-03-11

Completion date

2019-08-21

Last updated

2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elasticity Imaging Techniques, Musculoskeletal Disease, Rotator Cuff Tendinitis, Tendinopathy

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.

Interventions

DIAGNOSTIC_TESTDiagnostic

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

A case-control study without intervention

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Tendon quality (SEL)	Baseline	Sonoelastography - strain elasticity

Secondary

Measure	Time frame	Description
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 (MRI)	Baseline	Magnetic Resonance
Tendon quality (US)	Baseline	Conventional ultrasound
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.

Other

Measure	Time frame	Description
Demographic	Baseline	Gender, age, bmi, education (level), duration of symptoms, symptom history

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026