Non-calcifying tendinopathy of supraspinatus tendon Musculoskeletal Diseases Non-calcifying tendinopathy
Conditions
Interventions
The treatment regimen requires administration of two treatment sessions with 3000 impulses separated by 7 days. The sham treatment will entail use of the Modulith SLK in which the shockwave generator
Sponsors
Storz Medical AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female patients 18 years of age or older (women of child-bearing potential must have a negative serum pregnancy test performed within 1 - 14 days prior to the treatment procedure) suffering from chronic non-calcific supraspinatus tendinopathy as diagnosed by X-ray, magnetic resonance imaging (MRI) and physical examination 2. Patient has not responded to a standard course of non-pharmacological and non-surgical conservative treatment for a minimum of 4 months. Non-surgical conservative treatment may consist of: therapeutic exercise, ultrasound, iontophoresis, cryotherapy, and immobilisation or activity modification. 3. Patient has not responded to non-surgical, pharmacological conservative treatment and has had at least one sub-acromial steroid injection and at least one course of the standard dose of prescribed non-steroidal anti-inflammatory drugs (NSAIDs) or other pharmacological therapy a minimum of thirty days prior to SV 4. Diagnosis of supraspinatus tendinopathy is only in one shoulder 5. Patient has free passive range of movement and at least 90 degrees active abduction in the affected shoulder 6. Patient is willing to participate in the study and return for all scheduled follow-up visits 7. Patient is capable of giving, and has given, written informed consent
Exclusion criteria
Exclusion criteria: 1. Patient has a history of uncontrolled severe hypertension (systolic pressure greater than 180 mmHg, diastolic pressure greater than 110 mmHg) 2. Patient has unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias 3. Patient has a white blood cell count less than 2,000 or greater than 15,000, and/or platelet count less than 50,000 4. Patient has a known bleeding disorder or is currently being treated with anticoagulant therapy 5. Patient is currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior to the SV 6. Patient has participated in any other shoulder pain treatment research study within 30 days prior to the SV 7. Patient has had prior shoulder surgery 8. Patient is complaining of pain in both shoulders 9. Patient has malignant tumours, irrespective of location 10. Patient has a cardiac pacemaker implant 11. Patient has anatomy that prevents the focusing of the device into the shoulder in the area of the supraspinatus tendon (e.g., extensive scarring, misalignment of side fractures, non-unions or delayed fracture healing, congenital malformation, etc.) 12. Patient has any upper extremity neurological disorder as diagnosed from focused neurological exam (e.g. thoracic outlet syndrome, reflex sympathetic dystrophy, etc.) 13. Patient has a full-thickness rotator cuff tear of any of four tendons as seen on MRI 14. Patient has an acromiohumeral interval less than 7 mm as measured on a standard AP X-ray or severe symptomatic degenerative changes in the glenohumeral or acromioclavicular joint 15. Patient has acute subacromial bursitis as diagnosed by physical examination findings and MRI 16. Patient has generalised polyarthritis, rheumatoid arthritis 17. Patient is allergic to local anaesthetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy: Constant-Murley Score (CMS), measured at baseline, 6 weeks and three months follow up 2. Safety (adverse effects), measured immediately after treatment, at the beginning of the second session of shock waves and at 6 weeks and three months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Roentgenographic and magnetic resonance images (MRI) changes, measured at baseline and three months follow up | — |
Countries
Italy
Outcome results
None listed