Effect of foot orthoses on pain and disability in patients with low back pain: a meta-analysis of randomized controlled trials

This study explores the impact of foot orthoses (FO) on pain and disability in low back pain (LBP) patients, providing new treatment evidence. A systematic search was conducted across PubMed, Cochrane Library, Scopus, Web of Science, Embase, Medline, CNKI, and Wanfang Database for randomized controlled trials (RCTs) on FO for LBP treatment, from database inception to July 12, 2025. Data extraction, quality assessment, subgroup analysis, and meta-analysis were performed. Seven RCTs with 423 participants were analyzed. Most studies had low bias risk, though one had high risk. GRADE assessment indicated low evidence quality. The meta-analysis showed FO significantly reduced pain (p = 0.0006) and disability (p = 0.0004) compared to controls. This study did not find a significant effect of preformed FO on pain relief and leg length discrepancy (LLD) insole on disability dysfunction (p < 0.05). No studies reported adverse events related to FO. FO is effective and safe for alleviating pain and disability in LBP patients. Conclusions should be interpreted cautiously due to the low quality and heterogeneity of the included studies. Future studies should concentrate on the long-term efficacy of FO and the identification of appropriate fabrication processes/materials for various LBP types.