Moosmayer Stefan, Ekeberg Ole Marius, Hallgren Hanna Bjørnsson, Heier Ingar, Kvalheim Synnøve, Blomquist Jesper, Pripp Are Hugo, Juel Nils Gunnar, Kjellevold Stein Harald, Brox Jens Ivar
Orthopedic Department, Martina Hansens Hospital, Dønskiveien 8, 1346, Gjettum, Norway.
Department for Physical Medicine and Rehabilitation, Helse Fonna Hospital, Stord, Tysevegen 64, Stord Sjukehus HF, 5416, Stord, Norway.
BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9.
For the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection.
The study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night.
The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis.
ClinicalTrials.gov: NCT02419040 , registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered).
对于肩部钙化性肌腱炎的治疗，存在多种治疗方案。常用的治疗措施包括口服镇痛药、皮质类固醇注射、体外冲击波疗法、超声引导下针刺与灌洗以及手术治疗。早期队列研究表明患者可能从这些治疗中获益，但关于各种治疗效果的随机研究较少且证据相互矛盾。在本研究中，我们旨在比较超声引导下针刺与灌洗（冲洗）联合类固醇注射与假冲洗联合或不联合额外类固醇注射的效果。
该研究将在挪威和瑞典的6家二级医疗机构进行。它被设计为一项务实的、随机的、三臂、平行组、双盲、假对照临床试验，随访2年。将对210名年龄在30岁及以上、有疼痛弧、阳性撞击征且钙沉积>5mm的患者进行研究。通过在线中央随机系统将患者随机分配至三种治疗方案之一。三个治疗组分别为冲洗联合肩峰下类固醇注射（冲洗组）、假冲洗联合肩峰下类固醇注射（类固醇组）或无肩峰下类固醇注射的假冲洗（安慰剂组）。在安慰剂组中，类固醇注射将被短效局部麻醉剂替代。所有患者将进行为期8周的标准化家庭治疗后物理治疗。随访时间为治疗后2周和6周、4个月、8个月、12个月和24个月，患者和结果评估者在分组时均处于盲态。主要结局指标为4个月随访时的牛津肩部评分。次要结局指标包括上肢快速DASH评分、EQ-5D-5L总体健康评分以及静息、活动和夜间疼痛的视觉模拟量表评分。
这项安慰剂对照试验的科学证据对于未来钙化性肌腱炎患者的治疗建议具有重要意义。
ClinicalTrials.gov：NCT02419040，于2015年4月10日注册；EudraCT：2015-002343-34，于2015年9月23日注册（追溯注册）。
