THE CLINICAL EFFECTIVENESS OF FOOT ORTHOSES FOR THE ALLEVIATION OF LOW BACK PAIN

Abstract

Objective: To establish the effect of customised functional foot orthoses on patients' pre-existing, idiopathic low back pain (LBP). Design: A matched-subject randomised controlled trial designed to test the hypothesis that the use of functional foot orthoses is effective in alleviating chronic, idiopathic LBP. The experimental group will receive customised functional foot orthoses and the control will be a 'wait-list' group who will be monitored for 6 months prior to receiving the intervention. Setting: Podiatry clinic in Ilkley, West Yorkshire with recruitment from the Leeds and Bradford Metropolitan District Council areas. Participants: Initial recruitment of 60 participants with LBP who meet the inclusion criteria and have given their written informed consent to take part in the study. Allowing for withdrawals, a minimum final number of 40 participants is expected. Intervention: The treatment group will receive customised standard functional foot orthoses, vacuum-formed from polypropylene by LBG Medical. Measurements: Changes in levels of perceived LBP will be measured using the Low Back Pain Rating Scale (LBPRS), the Million Visual Analog Scale (VAS), and functional health status will be measured using the Oswestry Disability Index (ODI) over an initial six month period for both the experimental and control group participants. After six months, the control group will receive the intervention and both groups will continue to be monitored; the experimental group for a minimum of six more months and the control group for twelve months, using the same measurements. Participants will complete the Global Perceived Effect (GPE) scale at the end of the trial in order to determine whether they consider their LBP to have changed since the start of the trial. Data analysis: Homogeneity between the control and experimental groups will be verified for the variables of age, height, weight and LBP at the start and end of the trial using the Student's t-test. The p-values will then be calculated to determine whether there is a statistically significant difference between baseline and final scores. Statistical significance will be considered reached if p < 0.05. Homogeneity of Body Mass Index (BMI) and the Foot Postural Index (FPI-6) between the groups will be assessed using the Mann-Whitney U-test, and, for gender, the Pearson's chi-squared test. The data obtained during the trial from the pain scales will be assessed using the Wilcoxon signed-ranks test. The data will be analysed using the SPSS statistics software package (IBM 2016). Conclusion: The proposed trial aims to address the short-comings of previous research into the alleviation of LBP with the use of functional foot orthoses and aims to support the hypothesis that customised functional foot orthoses significantly help to alleviate LBP in people who have biomechanical abnormalities. Dissemination: The proposed trial will be registered with The International Committee of Medical Journal Editors (ICMJE 2017) and the editorial committees of relevant medical journals will be approached regarding publication.