Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425344
• Other study ID #: SEL_Supraspinatus_cross
• Status: Completed
• Phase: N/A
• Start date: March 11, 2018
• Est. completion date: August 21, 2019

Study information

• Verified date: August 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 21, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Elasticity Imaging Techniques
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense

Sponsors (6)

Lead Sponsor	Collaborator
Karen Brage	Gigtforeningen, Odense University Hospital, Radiograf Rådet, Region of Southern Denmark, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic	Gender, age, bmi, education (level), duration of symptoms, symptom history	Baseline
Primary	Tendon quality (SEL)	Sonoelastography - strain elasticity	Baseline
Secondary	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.	Baseline
Secondary	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).	Baseline
Secondary	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.	Baseline
Secondary	Tendon quality (MRI)	Magnetic Resonance	Baseline
Secondary	Tendon quality (US)	Conventional ultrasound	Baseline