Efficacy and safety of foot orthoses for improving pain and function in patients with plantar fasciitis: a systematic review and meta-analysis of randomized controlled trials

This study aims to investigate the efficacy and safety of foot orthoses (FO) in improving pain and function among patients with plantar fasciitis. Seven databases were searched from the time of construction to February 2025. Include randomized controlled trials (RCTs) evaluating the effects of foot orthoses on pain and function in patients with plantar fasciitis for data extraction, quality assessment, meta-analysis, and subgroup analysis. A random-effects model was used to calculate the pooled effect size and its 95% confidence interval (CI), with pain and foot function as the primary outcome measures. Eight RCTs involving 391 patients were analyzed. Meta-analysis revealed that compared with the control group, the experimental group demonstrated significant efficacy in alleviating pain in patients with plantar fasciitis (<i>p</i> = 0.0003). However, no significant differences were observed in foot function (<i>p</i> = 0.23) or walking ability (<i>p</i> = 0.44). No adverse events related to foot orthoses (FO) were reported in the studies. FO effectively alleviates pain symptoms in patients with plantar fasciitis, but no clinically meaningful statistical differences were observed in functional improvement. Further high-quality, large-sample, multicenter randomized controlled trials are needed to confirm these findings. Foot orthoses (FO) can alleviate foot pain in patients with plantar fasciitis (PF) and are generally associated with few or no adverse effects.The effect of FO on improving the pain of PF patients differed significantly among different cultural regions, which suggests that the efficacy is not “one size fits all” and needs to be individualized according to the local clinical environment and patient characteristics.Rehabilitation professionals should consider FO as an adjunct rather than the sole treatment option for PF patients, as current evidence is insufficient to support its significant efficacy in improving foot function and walking ability. Foot orthoses (FO) can alleviate foot pain in patients with plantar fasciitis (PF) and are generally associated with few or no adverse effects. The effect of FO on improving the pain of PF patients differed significantly among different cultural regions, which suggests that the efficacy is not “one size fits all” and needs to be individualized according to the local clinical environment and patient characteristics. Rehabilitation professionals should consider FO as an adjunct rather than the sole treatment option for PF patients, as current evidence is insufficient to support its significant efficacy in improving foot function and walking ability.