EUCTR2015-002343-34-NO进行中（未招募）1 期
Treatment of calcific tendinitis of the Rotator Cuff A randomized, double blinded, sham controlled, international, multicenter study
Martina Hansens Hospital0 个研究点目标入组 210 人开始时间: 2015年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.30 years or older
- •2.3 months or more of shoulder pain
- •3.Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
- •4. Painful arc
- •5.Positive Hawkin's test and/or Neer's sign for impingement
- •6.Finding of one or more calcifications =5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle,
- •together with a sonographic finding of one or more calcifications =5 mm in size on the short or long axis view, localized in
- •the supraspinatus or infraspinatus tendon
- •7.Morphological radiographic appearance of Molé type A, B or C
- •A: Dense, homogeneous with well-defined limits
- •B: Dense, fragmented with well-defined limits
- •C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance
- •8.Ability to understand written and spoken Norwegian
- •9.Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on
- •ultrasound together with an acute onset of extreme shoulder pain
- •2.Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or
- •cervical radiculopathy
- •3.Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps
- •4.A history of surgical treatment of the relevant shoulder
- •5.Any subacromial injection with a corticosteroid during the last 3 months before inclusion
- •6.Medical contraindications for any of the invasive procedures
- •7.One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys.
- •8.One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex.
- •9.Concomitant medication with one of the following medicinal products: Anti-arrythmics such as mexiletine or class III antiarrythmics (e.g. amiodarone), muscle relaxants (e.g. suxamethonium) or antipsychotics (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine, tropisetrone, dolasetron), antibiotics such as quinopristin/dalfopristin.
- •10.Any history of prior allergic/hypersensitivity reactions related to the study medication
- •11.Knowledge of an ongoing pregnancy (Fertile women not using contraception and who are uncertain whether they are pregnant or not will
- •have to perform a pregnancy test)
- •12.Nursing women
研究者
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