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
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedStudy Start
First participant enrolled
March 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2019
CompletedAugust 22, 2019
August 1, 2019
1.3 years
February 1, 2018
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Tendon quality (SEL)
Sonoelastography - strain elasticity
Baseline
Secondary Outcomes (5)
Pain on a VAS scale
Baseline
Quality of life on the E!-5D-3L questionnaire
Baseline
Disability
Baseline
Tendon quality (MRI)
Baseline
Tendon quality (US)
Baseline
Other Outcomes (1)
Demographic
Baseline
Study Arms (1)
Diagnostic
OTHERAll participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.
Interventions
No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karen Bragelead
- Odense University Hospitalcollaborator
- Sygehus Lillebaeltcollaborator
- Gigtforeningencollaborator
- Region of Southern Denmarkcollaborator
- Radiograf Rådetcollaborator
Study Sites (1)
University of Southern Denmark
Odense, 5230, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Birgit Juul-Kristensen, Assoc. Prof
Department of Sport Science and Biomechanics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ph.D-student
Study Record Dates
First Submitted
February 1, 2018
First Posted
February 7, 2018
Study Start
March 11, 2018
Primary Completion
July 1, 2019
Study Completion
August 21, 2019
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share