Background

Injectable therapies have been increasingly investigated to treat plantar fasciitis in randomized controlled trials (RCT) where normal saline injections are frequently used as placebo. The purpose was to quantify the effect of saline injections and compared against available minimal clinically important difference (MCID) criteria specific for plantar fasciitis to assess if changes were clinically meaningful.

Methods

RCT including a placebo group (normal saline) and reporting changes in pain and functional outcomes in plantar fasciitis were identified through a search in MEDLINE, Embase, Web of Science, and Scopus to February 2022. PRISMA guidelines and a registered protocol (PROSPERO: CRD42020214035) were followed to conduct the study.

Results

Pooled analysis of 13 RCT (379 subjects) included for analysis revealed a significant improvement on pain (P < .00001) and functional scores (P < .00001) after normal saline injections. These changes exceeded the established MCID criteria.

Conclusions

Normal saline injections in plantar fasciitis showed a therapeutic effect with statistically and clinically meaningful improvement when administered in the setting of an RCT for up to 12 months. The control of potential confounders influencing the effect of saline injections is required for future research.

中文翻译：

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注射生理盐水对足底筋膜炎患者产生治疗效果：随机对照试验的系统评价和荟萃分析

背景

在随机对照试验 (RCT) 中，注射疗法被越来越多地研究用于治疗足底筋膜炎，其中生理盐水注射经常用作安慰剂。目的是量化生理盐水注射的效果，并与足底筋膜炎特有的最小临床重要差异 (MCID) 标准进行比较，以评估变化是否具有临床意义。

方法

通过在 MEDLINE、Embase、Web of Science 和 Scopus 中进行搜索，确定了截至 2022 年 2 月的 RCT，包括安慰剂组（生理盐水）和报告足底筋膜炎疼痛和功能结果的变化。PRISMA 指南和注册方案（PROSPERO：CRD42020214035 ) 进行了研究。

结果

对纳入分析的 13 项 RCT（379 名受试者）的汇总分析显示，注射生理盐水后疼痛 ( P < .00001 ) 和功能评分 ( P < .00001 ) 有显着改善。这些变化超出了既定的 MCID 标准。

结论

在长达 12 个月的随机对照试验中，生理盐水注射治疗足底筋膜炎显示出具有统计学和临床​​意义改善的治疗效果。未来的研究需要控制影响盐水注射效果的潜在混杂因素。