Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain : a study protocol for a randomised controlled trial

Background: Prefabricated foot orthoses are used to treat chronic nonspecific low back pain, however their effectiveness and potential mechanism of action is unclear. The primary aims of the study are to investigate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52weeks. Methods: This study is a participant and assessor blinded, parallel-group, superiority randomised (1:1) controlled trial. The study will recruit 60 participants aged 18 to 65years with chronic nonspecific low back pain. Participants will undergo randomisation to a control group (The Back Book) or an intervention group (prefabricated foot orthoses and The Back Book). The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12weeks, physical activity over 12, 26, and 52weeks, and correlation between foot type and change in measures of pain and function. Number of hours per day and week that the prefabricated orthoses are worn, as well as, adverse events will be self-reported by participants. Data will be analysed using the intention-to-treat principle. Discussion: This trial will primarily evaluate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52weeks. It is expected that this study will provide clinicians and researchers with an understanding of the role that prefabricated foot orthoses may have in the treatment of chronic nonspecific low back pain and a potential mechanism of action, and whether foot type influences the outcome.