Objectives: The objective of this 30-week randomized crossover trial was to determine whether a multi-modal realignment therapy would be successful in relieving pain and improving function among persons with medial tibiofemoral OA.
METHODS: We conducted a double blind, randomized crossover trial of a multi-modal realignment therapy for persons with medial tibiofemoral OA. Trial participants met ACR criteria for OA with knee pain, aching or stiffness on most days of the past month and radiographic evidence of a definite osteophyte with predominant medial tibiofemoral OA. We tested two different treatments: A) CONTROL TREATMENT consisting of a neutral knee brace (no valgus angulation), flat unsupportive foot orthoses, and shoes with a flexible midsole; and B) ACTIVE TREATMENT consisting of a valgus knee brace, customized neutral foot orthoses, and shoes designed for motion control. For each subject, the trial lasted 30 weeks, including 12 weeks each of active and control treatment separated by a 6-week washout period. The primary outcome of the linear regression model was change in knee pain and function as assessed by the WOMAC Osteoarthritis Index.
RESULTS: 80 participants with medial tibiofemoral OA were randomized. Their mean age was 62 years, mean BMI was 34 kg/m2 and mean WOMAC pain score was 9.2 (0-20 scale). There was no evidence of a carryover effect. The regression model demonstrated that the mean difference in pain between the active and control treatments was -1.82 units (95% confidence interval: -3.05 to -0.60 [p=0.004]) on the WOMAC pain scale, indicating a small, but statistically significant decrease in pain with the multi-modal active treatment. For WOMAC function the realignment intervention had a non-significant effect on function with a -2.90 unit decrease (95% CI -6.60 to 0.79) compared with the control condition (p=0.12).
CONCLUSION: Multi-modal realignment therapy decreases pain in persons with medial tibiofemoral OA.