Purpose: This study explores the impact of foot orthoses (FO) on pain and disability in low back pain (LBP) patients, providing new treatment evidence.
Methods: 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.
Results: 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.
Conclusion: 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.
Keywords: Foot orthoses; disability; low back pain; meta-analysis; pain.
Low-quality evidence suggests that foot orthoses (FO) are effective in improving pain and disability in patients with low back pain (LBP).Subgroup analysis indicated that customized high-temperature thermoplastic FO were effective in treating LBP, while the use of leg length discrepancy (LLD) insoles could alleviate pain but did not have a significant impact on disability dysfunction.Rehabilitation professionals may consider FO as an adjunctive treatment for LBP, especially for patients who also have a pronated foot, flat foot, or LLD.Rehabilitation professionals should exercise caution when selecting FO types and intervention timing for LBP treatment, as current evidence is insufficient to support the significant efficacy of prefabricated FO or long-term FO interventions.