Randomised controlled trial dataset: effect of customised foot orthoses to reduce pain and plantar pressure in patients with pes cavus (high arch foot deformity)

This dataset is an output of a randomised controlled trial conducted to measure the effect of custom orthoses on foot pain and plantar pressure in one hundred and fifty four patients with pes cavus. Patients with a cavus or high-arched foot frequently experience foot pain, which can lead to significant limitation in function. Custom foot orthoses are widely prescribed to treat cavus foot pain. However, no clear guidelines for their construction existed at the time of data collection, and there is limited evidence of their efficacy.

In a randomized, single-blind, sham-controlled trial, the effect of custom foot orthoses on foot pain, function, quality of life, and plantar pressure loading in people with a cavus foot type was investigated. One hundred fifty-four participants with chronic musculoskeletal foot pain and bilateral cavus feet were randomly assigned to a treatment group receiving custom foot orthoses (n = 75) or to a control group receiving simple sham insoles (n = 79).

At 3 months, 99% of the participants provided follow-up data using the Foot Health Status Questionnaire. Foot pain scores improved more with custom foot orthoses than with the control (difference, 8.3 points; 95% confidence interval [CI], 1.2 to 15.3 points; P = .022). Function scores also improved more with custom foot orthoses than with the control (difference, 9.5 points; 95% CI, 2.9 to 16.1 points; P = .005). Quality-of-life data favoured custom foot orthoses, although differences reached statistical significance only for physical functioning (difference, 7.0 points; 95% CI, 1.9 to 12.1 points; P = .008). Plantar pressure improved considerably more with custom foot orthoses than with the control for all regions of the foot (difference, –3.0 N . s/cm2; 95% CI, –3.7 to –2.4 N . s/cm2; P < .001).

Data was collected in spreadsheets (.csv, excel), and analysed using SPSS. This dataset contains identifying information.

This description is drawn from an abstract available on PubMed: http://www.ncbi.nlm.nih.gov/pubmed/16707631. For further information, refer to the summary on the International Standard Randomised Controlled Trial Number Register (ISRCTN Register), and associated publications below.