A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study

Background: This study examined the effect of treatment with a novel biomechanical device on the level of pain and function in patients with knee OA. Methods: Patients with bilateral knee OA were enrolled to active and control groups. Patients were evaluated at baseline, at 4 weeks and at the 8-week endpoint. A novel biomechanical device was individually calibrated to patients from the active group. Patients from the control group received an identical foot-worn platform without the biomechanical elements. Primary outcomes were the WOMAC Index and ALF assessments. Results: There were no baseline differences between the groups. At 8 weeks, the active group showed a mean improvement of 64.8% on the WOMAC pain scale, a mean improvement of 62.7% on the WOMAC function scale, and a mean improvement of 31.4% on the ALF scale. The control group demonstrated no improvement in the above parameters. Significant differences were found between the active and control groups in all the parameters of assessment. Conclusions: The biomechanical device and treatment methodology is effective in significantly reducing pain and improving function in knee OA patients. The study is registered at clinicaltrials.gov, identifier NCT00457132, http://www.clinicaltrials.gov/ct/show/NCT00457132?order=1