Extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus

Completed

• Conditions: on-calcifying tendinopathy of supraspinatus tendon; Musculoskeletal Diseases; Non-calcifying tendinopathy

• Registration Number: ISRCTN41236511
• Lead Sponsor: Storz Medical AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Efficacy: Constant-Murley Score (CMS), measured at baseline, 6 weeks and three months follow up<br>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 Outcome Measures

Name	Time	Method
Roentgenographic and magnetic resonance images (MRI) changes, measured at baseline and three months follow up