ISRCTN41236511
Completed
N/A
Extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomised, placebo-controlled trial
Storz Medical AG (Switzerland)0 sites20 target enrollmentDecember 20, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- on-calcifying tendinopathy of supraspinatus tendon
- Sponsor
- Storz Medical AG (Switzerland)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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