Department of Anesthesiology, and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD; Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD; Department of Physical Medicine and Rehabilitation, Johns Hopkins School of Medicine, Baltimore, MD; Department of Anesthesiology, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD; Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD.
Department of Anesthesiology, and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD.
Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8.
OBJECTIVES: To determine the prevalence of intra- and extra-articular sacroiliac joint (SIJ) pain, which injection is more beneficial, and whether fluoroscopy improves outcomes. PATIENTS AND METHODS: This patient- and evaluator-blinded comparative effectiveness study randomized 125 participants with SIJ pain from April 30, 2014, through December 12, 2017, to receive fluoroscopically guided injections into the joint capsule (group 1) or "blind" injections to the point of maximum tenderness using sham radiographs (group 2). The primary outcome was average pain on a 0 to 10 scale 1 month after injection. A positive outcome was defined as at least a 2-point decrease in average pain score coupled with positive (>3) satisfaction on a Likert scale from 1 to 5. RESULTS: For the primary outcome, no significant differences were observed between groups (mean ± SD change from baseline, -2.3±2.4 points in group 1 vs -1.7±2.3 points in group 2; 95% CI, -0.33 to 1.36 points for adjusted difference; P=.23), nor was there a difference in the proportions of positive blocks (61% vs 62%) or 1-month categorical outcome (48% vs 40% in groups 1 and 2, respectively; P=.33). At 3 months, the mean ± SD reductions in average pain (-1.8±2.1 vs -0.9 ± 2.0 points; 95% CI, 0.11 to 1.58 points for adjusted difference; P=.02) and worst pain (-2.2±2.5 vs -1.4±2.0 points; 95% CI, 0.01 to 1.66 points for adjusted difference; P=.049) were greater in group 1 than 2, with other outcome differences falling shy of statistical significance. CONCLUSION: Although fluoroscopically guided injections provide greater intermediate-term benefit in some patients, these differences are modest and accompanied by large cost differences. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02096653.
目的：确定骶髂关节（SIJ）关节内和关节外疼痛的患病率，哪种注射更有效，以及透视是否能改善结果。
患者和评估者均为盲法的这项比较有效性研究于 2014 年 4 月 30 日至 2017 年 12 月 12 日期间随机将 125 名 SIJ 疼痛患者分为两组：接受透视引导的关节囊内注射（第 1 组）或使用模拟射线照片进行“盲目”注射至压痛最明显处（第 2 组）。主要结局是注射后 1 个月时 0 到 10 分制的平均疼痛。阳性结果定义为平均疼痛评分至少降低 2 分，同时在 1 到 5 分的李克特量表上的满意度为阳性（>3 分）。
结果：对于主要结局，两组之间无显著差异（组 1 从基线的平均变化±标准差为-2.3±2.4 分，组 2 为-1.7±2.3 分；调整差异的 95%置信区间为-0.33 至 1.36 分；P=.23），阳性阻滞的比例（61%与 62%）或 1 个月分类结局（组 1 和 2 分别为 48%与 40%；P=.33）也无差异。3 个月时，平均疼痛的平均变化（-1.8±2.1 分比-0.9 ± 2.0 分；调整差异的 95%置信区间为 0.11 至 1.58 分；P=.02）和最严重疼痛的平均变化（-2.2±2.5 分比-1.4±2.0 分；调整差异的 95%置信区间为 0.01 至 1.66 分；P=.049）在组 1 中大于组 2，其他结局差异则无统计学意义。
结论：虽然透视引导注射在某些患者中提供了更大的中期益处，但这些差异是适度的，且伴随着巨大的成本差异。
试验注册：clinicaltrials.gov 标识符：NCT02096653。
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