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首页> 外文OA文献 >Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care.
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Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care.

机译：皮质类固醇激素注射治疗肩部疼痛：基层医疗的单盲随机先导试验。

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BACKGROUND: Shoulder pain is a very common presentation in primary care. Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up. We plan a large, definitive, primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy, and conducted a pilot trial to explore feasibility. METHODS: Six general practitioners (GPs) from Oxfordshire, UK underwent update training in assessing painful shoulders and injecting the subacromial space. Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months. Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1% (total volume 1 ml), or lidocaine 1% alone (total volume 1 ml), injected into the subacromial space. The participants were blinded to treatment allocation. Feasibility outcomes were rates of recruitment, withdrawal, adherence to the protocol, completeness of follow-up, and success of patient masking. Clinical outcomes were the Oxford Shoulder Score (OSS) at baseline and at 4 and 12 weeks, and responses to three satisfaction questions at 2, 4 and 12 weeks. Outcome data were collected by postal questionnaires. RESULTS: A total of 40 participants were randomized (80% of the target 50 participants) over 26 weeks giving an overall recruitment rate of 1.5 participants per week. Rates of follow-up were maintained to a high level for the full 12 weeks. Four participants requested a 'rescue' corticosteroid injection but no patients withdrew. The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure. The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported. CONCLUSIONS: It is feasible to recruit participants with shoulder pain in the primary care setting for a blinded, randomized trial of corticosteroid injection. Online randomization of participants from the practice is also feasible, and postal questionnaires provide an effective means of gathering outcome data in this area of study. The lessons learned from this pilot will usefully inform the design of a large, definitive efficacy trial in primary care. TRIAL REGISTRATION: Current Clinical Trials ISRCTN82357435.
机译：背景：肩痛是基层医疗中非常普遍的表现。肩峰皮质激素注射后获益的证据尚无定论，且主要限于随访时间短的研究。我们计划进行一项大型的，确定性的，以初级保健为基础的试验，以确定肩袖肌腱病患者的疗效和安全性，并进行了一项中试试验以探讨可行性。方法：来自英国牛津郡的六名全科医生（GP）接受了评估疼痛肩部和注射肩峰下间隙的最新培训。然后每人招募35-74岁的初级保健患者，他们抱怨肩痛持续不超过6个月。符合条件的参与者被随机分配接受40 mg醋酸甲泼尼龙（含1％利多卡因（总体积1 ml），或单独接受1％利多卡因（总体积1 ml），注入肩峰下间隙。参与者对治疗分配视而不见。可行性结果包括招募，退出，遵守方案，随访的完整性以及患者掩盖的成功率。临床结果为基线，第4周和第12周的牛津肩膀评分（OSS），以及第2周，第4周和第12周对三个满意度问题的回答。通过邮政调查表收集结果数据。结果：总共40名参与者在26周内被随机分组​​（占目标50名参与者的80％），每周总招聘率为1.5名参与者。整整12周的随访率保持在较高水平。四名参与者要求“抢救”皮质类固醇注射，但没有患者退出。试验全科医生的高分表示他们对患者在手术过程中对治疗分配不知情的信心。报告第4周和第12周的OSS以及对满意度问题的回答。结论：在初级保健机构中招募患有肩痛的参与者进行皮质类固醇注射剂的盲法，随机试验是可行的。从实践中对参与者进行在线随机分组也是可行的，邮政调查表提供了一种收集该研究领域结果数据的有效手段。从该试点中学到的经验教训将有益地指导一项大型的确定性初级保健功效试验的设计。试验注册：当前临床试验ISRCTN82357435。

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