ISRCTN41236511已完成不适用
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 个研究点目标入组 20 人开始时间: 2010年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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