Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial
Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial
复制标题
DOI：
10.1136/bmj.k2860
复制
发表时间：
2018-07-19
影响因子：
105.7
通讯作者：
Jarvinen, Teppo L. N.
中科院分区：
文献类型：
--
作者：
Paavola, Mika;Malmivaara, Antti;Jarvinen, Teppo L. N.
目的：在更实际的情况下，通过将关节镜下肩峰下减压术（ASD）与诊断性关节镜手术（安慰剂手术干预）和非手术替代疗法（运动疗法）进行比较，评估ASD的疗效。研究对象：210名有肩关节撞击症状的患者，综合征，从2005年2月1日开始招募，到2015年6月25日完成2年随访。干预SASD、诊断性关节镜检查（安慰剂对照）和运动疗法。主要结果测量24个月时休息时和手臂活动时的肩痛（视觉模拟评分（VAS）从0到100，0表示没有疼痛）。最小临床重要差异的阈值设定为15.0ms。在主要意向治疗分析（ASD与诊断性关节镜检查）中，在24个月时的两个主要结局中未观察到具有临床意义的组间差异（ASD的平均变化为静息时36.0，活动时55.4;诊断性关节镜检查为静息时31.4，活动时47.5）。观察到的组间疼痛VAS平均差异（ASD减去诊断性关节镜检查）在休息时为-4.6（95%置信区间-11.3至2.1）分（P=0.18），在手臂活动时为-9.0（-18.1至0.2）分（P=0.054）。ASD组和诊断性关节镜组在次要结局或不良事件方面没有组间差异。在二次比较中（ASD与运动疗法），在24个月时的两个主要结局（静息VAS）中，发现统计学显著差异有利于ASD（-7.5，-14.0至-1.0，分; P=0.023）和手臂活动VAS（-12.0，-20.9至-3.2，分; P=0.008），但组间平均差异未超过预先规定的最小临床重要差异。值得注意的是，这种ASD与运动疗法的比较不仅由于缺乏盲法而混淆，而且由于选择性地从ASD组中排除了可能预后不良的患者，而没有从运动疗法组中排除类似的患者，因此可能偏向于ASD，在24个月时，关节镜肩峰下减压术与诊断性关节镜手术相比没有任何益处。
OBJECTIVETo assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.DESIGNMulticentre, three group, randomised, double blind, sham controlled trial.SETTINGOrthopaedic departments at three public hospitals in Finland.PARTICIPANTS210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.INTERVENTIONSASD, diagnostic arthroscopy (placebo control), and exercise therapy.MAIN OUTCOME MEASURESShoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.RESULTSIn the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.CONCLUSIONSIn this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.