Vanden Bossche Luc, Vanderstraeten Guy
Physical and Rehabilitation Medicine, Sportsmedicine, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium.
Department of Rehabilitation Sciences and Physical Therapy, Faculty of Medicine and Health Sciences, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium.
BMC Musculoskelet Disord. 2015 Feb 4;16(1):8. doi: 10.1186/s12891-015-0471-z.
Shoulder pain is a common musculoskeletal symptom with a wide range of potential causes; however, the majority of conditions can be managed with conservative treatment. The aim of this study is to assess the efficacy and safety of Traumeel injections versus corticosteroid injections and placebo in the treatment of rotator cuff syndrome and bursitis and expand the current evidence base for the conservative treatment of rotator cuff syndrome.
METHODS/DESIGN: This is a multi-center, randomized, double-blind, 16-week, three-arm, parallel-group, active- and placebo-controlled trial to assess the efficacy and safety of Traumeel 2 ml injection versus dexamethasone 8 mg injection versus placebo (saline solution). Patients will be randomly allocated to Traumeel, dexamethasone or placebo in a 2:2:1 randomization. After 1 week screening, patients will receive 3 injections at weekly intervals (days 1, 8 and 15) with additional follow-up assessments on day 22, a telephone consultation in week 9 and a final visit at week 15. Male and female patients aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of chronic rotator cuff syndrome and/or bursitis. Patients with calcifications in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 patients will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be paracetamol (acetaminophen), with usage recorded. The primary endpoint is change from baseline in abduction-rotation pain visual analog scale (0-100 mm scale, 0 corresponds to no pain and 100 to extreme pain) at day 22 (Traumeel injections versus dexamethasone injections) for active external rotation. Secondary efficacy parameters include range of motion, disability of arm, shoulder, hand score and patient's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to dexamethasone regarding the primary efficacy parameter.
It is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease.
ClinicalTrials.gov: NCT01702233 . EudraCT number: 2012-003393-12.
肩部疼痛是一种常见的肌肉骨骼症状，潜在病因广泛；然而，大多数情况可通过保守治疗进行处理。本研究的目的是评估创伤弧菌注射剂与皮质类固醇注射剂及安慰剂在治疗肩袖综合征和滑囊炎方面的疗效和安全性，并扩充目前肩袖综合征保守治疗的证据基础。
方法/设计：这是一项多中心、随机、双盲、为期16周的三臂平行组活性药物与安慰剂对照试验，旨在评估2毫升创伤弧菌注射剂与8毫克地塞米松注射剂及安慰剂（盐溶液）的疗效和安全性。患者将按2:2:1的随机比例被随机分配至创伤弧菌组、地塞米松组或安慰剂组。在1周的筛查期后，患者将每隔一周（第1、8和15天）接受3次注射，并在第22天进行额外的随访评估，在第9周进行电话咨询，在第15周进行末次访视。年龄在40至65岁（含）的男性和女性患者，若患有慢性肩袖综合征和/或滑囊炎的急性发作，将被纳入研究。肩关节有钙化或肩袖完全撕裂的患者将被排除。至少将招募160名患者。所有肩峰下注射将在超声引导下采用常规技术进行。唯一允许使用的急救药物将是对乙酰氨基酚，并记录其使用情况。主要终点是在第22天（创伤弧菌注射剂与地塞米松注射剂对比）主动外旋时，外展-旋转疼痛视觉模拟量表（0至100毫米量表，0表示无疼痛，100表示极度疼痛）相对于基线的变化。次要疗效参数包括活动范围、上肢、肩部、手部功能障碍评分以及患者/研究者的整体评估。临床疗效将根据主要疗效参数评估创伤弧菌相对于地塞米松的非劣效性。
希望本试验的结果能扩充可用于肩袖疾病管理的治疗选择和证据基础。
ClinicalTrials.gov：NCT01702233。欧洲临床试验数据库编号：2012-003393-12。
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