Elasticity Imaging Techniques, Musculoskeletal Disease, Rotator Cuff Tendinitis, Tendinopathy
Conditions
Brief summary
This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.
Detailed description
The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark. The intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals. Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline
Interventions
OTHERLow Load Exercises
All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps). The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).
Sponsors
Odense University Hospital
Sygehus Lillebaelt
Gigtforeningen
Region of Southern Denmark
Radiograf Rådet
Karen Brage
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendon quality (SEL) | Baseline and 12 weeks | Change from baseline in tendon quality (sonoelastography - strain elasticity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strength | Baseline and 12 weeks | Change from baseline in Isometric Strength (MVC) |
| Recovery | 12 weeks | Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement. |
| Tendon quality (MRI) | Baseline and 12 weeks | Change from baseline in tendon quality (MRI) |
| Pain | Baseline and 12 weeks | Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain. |
| Tendon quality (US) | Baseline and 12 weeks | Change from baseline in tendon quality (conventional ultrasound) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic | Baseline | Gender, age, bmi, education (level), duration of symptoms, symptom history |
| Disability | Baseline and 12 weeks | 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. |
| Quality of life | Baseline and 12 weeks | 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). |
Countries
Denmark
Outcome results
None listed