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.