A randomised controlled trial investigating the effect of foot orthoses for the treatment of chronic nonspecific low back pain

Objectives: The primary aim was to investigate the effect of prefabricated foot orthoses on pain and function in people with chronic nonspecific low back pain (LBP). Secondary aims were to report on the recruitment rate, adherence to and safety of these interventions, and the relationship between physical activity and pain and function.Design: A two-arm parallel group (intervention vs. control) randomised (1:1) controlled trial.Subjects: Forty-one participants with chronic nonspecific LBP.Intervention: Twenty participants were randomised to the intervention group (prefabricated foot orthotic and The Back Book) and 21 to the control group (The Back Book). The primary outcomes for this study were change in pain and function from baseline to 12 weeks.Results: No statistically significant difference in pain was found between the intervention and control group (adjusted mean difference -0.84, 95% CI: -2.09 to 0.41, p = 0.18) at the 12-week follow-up. No statistically significant difference in function was found between the intervention and control group (adjusted mean difference -1.47, 95% CI: -5.51 to 2.57, p = 0.47) at the 12-week follow-up.Conclusion: This study found no evidence of a significant beneficial effect of prefabricated foot orthoses for chronic nonspecific LBP. This study demonstrated that the rate of recruitment, intervention adherence and safety, and participant retention is acceptable and supportive of conducting a larger randomised controlled trial.Australian and New Zealand Clinical Trials Registry (ACTRN12618001298202).