Tendinopathy Clinical Trial
Official title:
Responsiveness of Sonoelastography in the Supraspinatus Tendon
Verified date | August 2019 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.
Status | Completed |
Enrollment | 23 |
Est. completion date | August 21, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Southern Denmark | Odense |
Lead Sponsor | Collaborator |
---|---|
Karen Brage | Gigtforeningen, Odense University Hospital, Radiograf Rådet, Region of Southern Denmark, Sygehus Lillebaelt |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life | 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 and 12 weeks | |
Other | 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 and 12 weeks | |
Other | Demographic | Gender, age, bmi, education (level), duration of symptoms, symptom history | Baseline | |
Primary | Tendon quality (SEL) | Change from baseline in tendon quality (sonoelastography - strain elasticity) | Baseline and 12 weeks | |
Secondary | Tendon quality (MRI) | Change from baseline in tendon quality (MRI) | Baseline and 12 weeks | |
Secondary | Tendon quality (US) | Change from baseline in tendon quality (conventional ultrasound) | Baseline and 12 weeks | |
Secondary | Strength | Change from baseline in Isometric Strength (MVC) | Baseline and 12 weeks | |
Secondary | Recovery | Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement. | 12 weeks | |
Secondary | Pain | Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain. | Baseline and 12 weeks |
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