Shoulder impingement shoulder injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex who have been clinically diagnosed with shoulder impingement. Calcification of the supraspinatus tendon has to be confirmed with both radiography and diagnostic ultrasound. 2. Integrity of the supraspinatus tendon. 3. Calcification diameter > 6 mm visible on a diagnostic radiograph less than six weeks old. 4. Patients may have calcification in one or both shoulders. For patients with bilateral calcifications, both shoulders will be included as separate cases. 5. Shoulder symptoms should be present > 6 months 6. Non-surgical treatment other than dry needling or aspiration has failed to improve symptoms in the previous six months 7. Patients over 18 years old
Exclusion criteria
Exclusion criteria: 1. Patients with radiographic or diagnostic ultrasound confirmed calcification of the subacromial bursa or calcification of the subscapularis tendon. 2. Previous shoulder surgery of any kind on the affected shoulder. 3. Total or partial rotator cuff rupture 4. Shoulder instability 5. Clinically verified acromioclavicular joint osteoarthritis 6. Patients who received no non-surgical treatment for their shoulder symptoms 7. Neurological symptoms or conditions (ie MS, Parkinson, CVA etc) 8. Injections in subacromial space in the previous three months. 9. Patients with psychosomatic complaints defined as a VAS-score for pain of * 90mm. 10. Patients with very mild shoulder pain, defined as a VAS-score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoints are pain at rest, shoulder function and amount of calcification. Shoulder function is measured using the DASH questionnaire and ROM. Shoulder pain is measured using a VAS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are quality of arm movement, safety of treatment and involved costs. Quality of arm movement will be measured using accelerometers. Safety is measured with recording of any (S)AE*s during the study. The costs per patient will be analysed for each study group. | — |
Countries
Netherlands