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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Sygehus Lillebaelt | OTHER |
| Gigtforeningen | OTHER |
| Region of Southern Denmark |
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This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Load Exercises | Experimental | An exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Load Exercises | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon quality (SEL) | Change from baseline in tendon quality (sonoelastography - strain elasticity) | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon quality (MRI) | Change from baseline in tendon quality (MRI) | Baseline and 12 weeks |
| Tendon quality (US) | Change from baseline in tendon quality (conventional ultrasound) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgit Juul-Kristensen, Assoc Prof | Department of Sport Science and Biomechanics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark | Odense | 5230 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33403207 | Derived | Brage K, Juul-Kristensen B, Hjarbaek J, Boyle E, Kjaer P, Ingwersen KG. Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study. Orthop J Sports Med. 2020 Dec 16;8(12):2325967120965185. doi: 10.1177/2325967120965185. eCollection 2020 Dec. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D000070636 | Rotator Cuff Injuries |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| D011187 | Posture |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| OTHER |
| Radiograf RĂ¥det | UNKNOWN |
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|
| Baseline and 12 weeks |
| Strength | Change from baseline in Isometric Strength (MVC) | Baseline and 12 weeks |
| 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 |
| 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 |
| Baseline and 12 weeks |
| 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 |
| Demographic | Gender, age, bmi, education (level), duration of symptoms, symptom history | Baseline |
| D000070599 |
| Shoulder Injuries |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D064797 | Physical Conditioning, Human |