Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
A Randomized Trial of Realignment Therapy for Treatment of Medial Tibiofemoral Osteoarthritis
Hunter1, David J., Gross2, K., McCree1, Paula I., Li1, Ling, Hirko1, Kelly, Zhang3, Bin, Harvey1, William
Biomechanical studies of persons with medial tibiofemoral OA demonstrate that even with appropriate valgus knee bracing, large medial forces remain, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value. The objective of this 30-week randomized crossover trial was to determine whether a multi-modal realignment therapy (consisting of valgus knee brace + motion control shoes + neutral foot orthoses) would be successful in relieving pain and improving function among persons with medial tibiofemoral OA.
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 of the past month and radiographic evidence of a definite osteophyte. 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 was change in knee pain and function as assessed by the WOMAC Osteoarthritis Index (VAS version). An unstructured correlation matrix for observations within subjects was used in generalized estimating equation fitting. The final linear regression model was conducted with exclusion of the differential carryover effect.
80 participants with medial tibiofemoral OA were randomized. 63% were female. Their mean age was 62 years, mean BMI was 34 kg/m2 and mean WOMAC pain score was 8.9 (020 scale). The main effects are depicted in the table below. There was no evidence of a carryover effect in the initial analyses. After removing the potential for carryover effect, the model demonstrated that the mean difference in pain between the active and control treatments was -0.86 units (95% confidence interval 1.74, 0.01 [p=0.05]) on the WOMAC pain scale (range 020), indicating a small decrease in pain in association with the multi-modal active treatment.
|Predictor||b coefficient for end of treatment WOMAC pain (negative values indicating a decrease in pain)|
|Active treatment (control as reference)||-0.86|
|(95% confidence interval)||(-1.74, 0.01)|
|Baseline WOMAC pain score||0.38|
|(95% confidence interval)||(0.19, 0.57)|
|Treatment, period 1 vs. period 2||-0.04|
|(95% confidence interval)||(-0.92, 0.84)|
The effects of multi-modal realignment therapy on pain and function in persons with medial tibiofemoral OA are small and of equivocal clinical and statistical significance.
To cite this abstract, please use the following information:
Hunter, David J., Gross, K., McCree, Paula I., Li, Ling, Hirko, Kelly, Zhang, Bin, et al; A Randomized Trial of Realignment Therapy for Treatment of Medial Tibiofemoral Osteoarthritis [abstract]. Arthritis Rheum 2009;60 Suppl 10 :828