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

Yaron Bar-Ziv, Yiftah Beer, Yuval Ran, Shaike Benedict, Nahum Halperin, Yaron Bar-Ziv, Yiftah Beer, Yuval Ran, Shaike Benedict, Nahum Halperin

Abstract

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.

Figures

Figure 1
Figure 1
Patient flow-chart.
Figure 2
Figure 2
The biomechanical device. (a) Bio-mechanical device comprising of two individually calibrated elements and a foot-worn platform which they are attached to under the hindfoot and forefoot regions. (b) Bio-mechanical elements are available in different degrees of convexity and resilience; (c) Height versatile base with 0.25 mm increments; (d) Specially designed sole includes two mounting rails and positioning matrix to enable flexible positioning of each bio-mechanical element.
Figure 3
Figure 3
Western Ontario and McMaster Osteoarthritis Index (WOMAC) over score mean values - distribution by age and gender. Time by treatment effect was significant in the active group in all 4 conditions. There was no significant time by treatment effect in the control group. P < 0.05

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