Michaut Alexia, Planche Lucie, Auzanneau Lucie, Cormier Grégoire
Department of Rheumatology, Departmental Hospital Center, La Roche sur Yon, Vendée, France
Departmental of Rheumatology, Vendée Departmental Hospital Center, La Roche sur Yon, France.
BMJ Open. 2020 Dec 10;10(12):e034439. doi: 10.1136/bmjopen-2019-034439.
Degenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing with the medical management of the disease have conducted no comparative assessment of drug therapies, physiotherapy, joint manipulation and corticosteroid injections. The primary goal of this study is to determine whether manual therapy is not inferior to ultrasound-guided injection of a corticosteroid preparation to decrease acromiocalvicular joint pain at 3 months.
The acromioclavicular arthropathy managed by manual therapy is a monocentric, comparative, randomised, controlled, non-inferiority study conducted in the Rheumatology Department of Vendée Departmental Hospital, involving two parallel groups receiving either corticosteroid injections or manual therapy. The inclusion criteria are patients who suffer from pain in the shoulder or the proximal part of the arm, with pain located on palpation of the acromioclavicular joint associated with a positive cross-arm test and a positive O'Brien test. Randomisation will be at a 1:1 ratio. The injection group will receive a single ultrasound-guided injection of 1 mL of Diprostène and the manual therapy group will receive between one and three sessions at intervals of one per week. The primary outcome will be to compare the Visual Analogue Scale for pain-activity-related score at 3 months for both groups.
The study project has been approved by the appropriate ethics committee (Committee for the Protection of Patients Ouest II in Angers, 30 April 2019, with the registration number of 2019/22). In agreement with current French regulations, signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
NCT03951480.
退行性肩锁关节疼痛约占肩部疼痛的4%。针对肩锁关节疾病有多种医学和非医学治疗策略，但对这些治疗方法进行比较评估存在困难。少数关于该疾病药物治疗的研究未对药物疗法、物理治疗、关节手法治疗和皮质类固醇注射进行比较评估。本研究的主要目的是确定手法治疗在减轻肩锁关节疼痛方面是否不劣于超声引导下注射皮质类固醇制剂，随访时间为3个月。
本项关于手法治疗肩锁关节病的研究为单中心、比较性、随机、对照、非劣效性试验，在旺代省立医院风湿病科进行，涉及两个平行组，分别接受皮质类固醇注射或手法治疗。纳入标准为肩部或手臂近端疼痛的患者，肩锁关节触诊时疼痛，交叉臂试验阳性且奥布赖恩试验阳性。随机分组比例为1:1。注射组将接受一次超声引导下1 mL双丙酸倍他米松注射，手法治疗组将接受每周一次，共一至三次治疗。主要结局指标是比较两组在3个月时与疼痛活动相关的视觉模拟量表评分。
本研究项目已获得相关伦理委员会批准（昂热西部患者保护委员会II，2019年4月30日，注册号2019/22）。根据法国现行法规，将获得每位患者签署的知情书面同意书。主要试验结果和次要终点结果将提交至同行评审期刊发表。
NCT03951480。
