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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03425357 |
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Date of registration:
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31/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sonoelastography of the Supraspinatus Tendon
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Scientific title:
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Responsiveness of Sonoelastography in the Supraspinatus Tendon |
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Date of first enrolment:
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March 25, 2018 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03425357 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Birgit Juul-Kristensen, Assoc Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Sport Science and Biomechanics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Able to read and understand Danish
- Shoulder pain > 3 months
- Positive on 3/5 clinical tests (full can, empty can, resisted external rotation,
neers, hawking)
- Tendinopathy (MRI)
Exclusion Criteria:
- BMI > 30
- Bilateral shoulder pain
- Supraspinatus full thickness rupture (US)
- Biceps rupture (US)
- Calcification in supraspinatus (X-ray)
- Pregnancy
- Glenohumeral arthrosis (X-ray)
- Frozen shoulder
- Shoulder symptoms originating from neck
- Shoulder fracture, operation or luxation
- Known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia,
spondylarthropathy or psychiatric disorders
- Labrum lesion (MRI)
- Tear (?1/3 of supraspinatus, vertical height) (MRI)
Age minimum:
40 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Elasticity Imaging Techniques
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Rotator Cuff Tendinitis
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Musculoskeletal Disease
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Tendinopathy
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Intervention(s)
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Other: Low Load Exercises
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Primary Outcome(s)
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Tendon quality (SEL)
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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Tendon quality (MRI)
[Time Frame: Baseline and 12 weeks]
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Strength
[Time Frame: Baseline and 12 weeks]
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Pain
[Time Frame: Baseline and 12 weeks]
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Recovery
[Time Frame: 12 weeks]
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Tendon quality (US)
[Time Frame: Baseline and 12 weeks]
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Secondary ID(s)
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Sonoelastography_Supraspinatus
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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