Objectives The objective of this 30-week randomised crossover trial was to determine whether a multi-modal realignment treatmentwould be successful in relieving pain and improving function among persons with medial tibiofemoral osteoarthritis (OA).
Methods The authors conducted a double-blind randomised crossover trial of a multi-modal realignment treatment for medial tibiofemoral OA. Trial participants met American College of Rheumatology 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. The authors 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 mid-sole; and (B) active treatment consisting of a valgus knee brace, customised neutral foot orthoses and shoes designed for motion control. For each subject, the trial lasted 30 weeks, including 12 weeks each of active treatment 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Results 80 participants with medial tibiofemoral OA were randomised. Their mean age was 62 years, their mean body mass index was 34 kg/m2 and their 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 treatment and the control treatment was −1.82 units (95% CI −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 treatment decreases pain in persons with medial tibiofemoral OA.
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Funding National Institute on Disability and Rehabilitation Research.
Competing interests None.
Patient consent Obtained.
Ethics approval Boston University institutional review board and the New England Baptist Hospital institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.