Back to resultsDiscriminative Validity of Strain Elastography of the Supraspinatus Tendon
Primary Purpose
Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diagnostic
Sponsored by
About this trial
This is an interventional diagnostic trial for Elasticity Imaging Techniques
Eligibility Criteria
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).
Sites / Locations
- University of Southern Denmark
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diagnostic
Arm Description
All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.
Outcomes
Primary Outcome Measures
Tendon quality (SEL)
Sonoelastography - strain elasticity
Secondary Outcome Measures
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.
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).
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.
Tendon quality (MRI)
Magnetic Resonance
Tendon quality (US)
Conventional ultrasound
Full Information
NCT ID
NCT03425344
First Posted
February 1, 2018
Last Updated
August 21, 2019
Sponsor
Karen Brage
Collaborators
Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
1. Study Identification
Unique Protocol Identification Number
NCT03425344
Brief Title
Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
Official Title
Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 11, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Brage
Collaborators
Odense University Hospital, Sygehus Lillebaelt, Gigtforeningen, Region of Southern Denmark, Radiograf Rådet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elasticity Imaging Techniques, Tendinopathy, Rotator Cuff Tendinitis, Musculoskeletal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A case-control study without intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic
Arm Type
Other
Arm Description
All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic
Intervention Description
No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
Primary Outcome Measure Information:
Title
Tendon quality (SEL)
Description
Sonoelastography - strain elasticity
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Pain on a VAS scale
Description
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
Title
Quality of life on the E!-5D-3L questionnaire
Description
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
Title
Disability
Description
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
Title
Tendon quality (MRI)
Description
Magnetic Resonance
Time Frame
Baseline
Title
Tendon quality (US)
Description
Conventional ultrasound
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Demographic
Description
Gender, age, bmi, education (level), duration of symptoms, symptom history
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, Assoc. Prof
Organizational Affiliation
Department of Sport Science and Biomechanics
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
ZIP/Postal Code
5230
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
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