Multi-modal realignment treatment decreases pain in people with medial tibiofemoral osteoarthritis

Abstract

Does a multi-modal realignment treatment relieve pain and improve function among persons with medial tibiofemoral osteoarthritis (OA)? A doubleblind (participant and assessor) 30 week randomised crossover trial. Participants were recruited from rheumatology and orthopaedic hospital departments and from persons already recruited for other clinical trials, using various forms of advertising in local public media in New England, USA. Ambulatory persons fulfilling American College of Rheumatology criteria for knee OA, with radiographically confirmed osteophytes and pain, aching or stiffness on most of the past 30 days, and radiographic evidence of disease in the medial tibiofemoral compartment were included. Key exclusion criteria included predominant lateral tibiofemoral or patellofemoral involvement, low WOMAC Pain scores (a minimal score of at least 2 out of 5 on at least 2 of the 5 questions was required for participation), use of ambulation aids and known causes of inflammatory arthritis. Active treatment included a valgus knee brace and customised neutral foot orthoses and motion control shoes, while control treatment was a neutral knee brace that does not have any varus/valgus angulation and a flat unsupportive foot orthosis and shoes with a flexible mid-sole. A run-in design was used in order to maximise the likelihood of recruiting subjects who would remain in the trial. Participants were randomised to receive either active treatment or control treatment for 12 weeks. Following a 6-week washout period, the alternative treatment was assigned for the final 12 weeks. Primary outcomes were the WOMAC Pain (0-20) and Function (0-68) subscales. 80 participants were randomised and 56 completed the study. The active realignment intervention had effect on pain with a -1.82 unit decrease (95% CI -3.05 to -0.60), and a non-significant effect on function [2.90 unit decrease (95% CI -6.60 to 0.79)] compared with the control condition. Multi-modal realignment treatment can decrease pain in persons with medial tibiofemoral OA.