Peña-Martínez Víctor Manuel, Acosta-Olivo Carlos, Tamez-Mata Yadira, Simental-Mendía Luis E, Blázquez-Saldaña Jaime, Vilchez-Cavazos Félix, Simental-Mendía Mario
Universidad Autonoma de Nuevo Leon, Orthopedics and Traumatology Service, "Dr. José Eleuterio González" University Hospital, Monterrey, Mexico.
Instituto Mexicano del Seguro Social, Biomedical Research Unit, Delegación Durango, Durango, Mexico.
Foot Ankle Surg. 2022 Dec;28(8):1129-1138. doi: 10.1016/j.fas.2022.04.005. Epub 2022 Apr 29.
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.
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.
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.
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.
在随机对照试验(RCT)中,人们越来越多地研究注射疗法来治疗足底筋膜炎,其中生理盐水注射经常被用作安慰剂。目的是量化生理盐水注射的效果,并与针对足底筋膜炎的现有最小临床重要差异(MCID)标准进行比较,以评估变化是否具有临床意义。
通过检索截至2022年2月的MEDLINE、Embase、科学引文索引和Scopus数据库,确定了包括安慰剂组(生理盐水)并报告足底筋膜炎疼痛和功能结局变化的随机对照试验。遵循PRISMA指南和注册方案(PROSPERO:CRD42020214035)进行研究。
对纳入分析的13项随机对照试验(379名受试者)进行汇总分析,结果显示生理盐水注射后疼痛(P <.00001)和功能评分(P <.00001)有显著改善。这些变化超过了既定的MCID标准。
在长达12个月的随机对照试验中,足底筋膜炎注射生理盐水显示出治疗效果,在统计学和临床上都有有意义的改善。未来的研究需要控制影响生理盐水注射效果的潜在混杂因素。