Maillefert J F, Hudry C, Baron G, Kieffert P, Bourgeois P, Lechevalier D, Coutaux A, Dougados M
Cochin Hospital, Rheumatology B, René Descartes University, Paris, France.
Osteoarthritis Cartilage. 2001 Nov;9(8):738-45. doi: 10.1053/joca.2001.0470.
To compare the clinical effects of laterally wedged insoles and neutrally wedged insoles (used as control) in patients with medial femoro-tibial knee osteoarthritis (OA).
6-month prospective randomized controlled study.
outpatients with painful medial femoro-tibial knee OA.
patient's overall assessment of disease activity (5 grade scale), WOMAC index subscales and concomitant treatments.
Performed as an intention-to-treat analysis. Main criterion: improvement in the patient's assessment of activity (defined as a reduction of 1 grade or more at month 6 compared to baseline, and no intraarticular injection or lavage during the study). Secondary criteria for assessment: (a) improvement in the patient's assessment of activity at months 1 and 3 compared to baseline, (b) improvement in the WOMAC subscales at months 1, 3 and 6, compared to baseline (defined as an improvement of at least 30%, and no intraarticular injection or lavage during the study) and (c) concomitant therapies (analgesics and NSAIDs).
The baseline characteristics of the 156 recruited patients (41 males, 115 females, mean age 64.8 years) were not different in the two treatment groups. At months 1, 3 and 6 the percentages of patients with improvement in assessment of disease activity, in WOMAC pain, joint stiffness, and physical functioning subscales were similar in the two groups. The number of days with NSAIDs intake during the previous 3 months was decreased at month 6 compared with baseline in the group furnished with laterally wedged insoles (14.1 days+/-28 vs 9.9 days+/-27, P=0.04, Wilcoxon paired test), while it remained unchanged in the other group (15.5 days+/-24 vs 15+/-28, P=0.56). Compliance and tolerance were satisfactory. Compliance was different between the two groups at month 6, with a greater frequency of patients who wore insoles permanently in the laterally wedged insole group than in the other group (87.8% vs 74.3%;P=0.032).
This study failed to demonstrate a relevant short-term symptomatic effect of laterally-wedged insoles in medial femoro-tibial OA. However, the decrease in NSAIDs consumption together with better compliance in the treated group are in favor of a beneficial effect of laterally-wedged insoles in medial femoro-tibial OA.
比较外侧楔形鞋垫与中性楔形鞋垫（作为对照）对股骨内侧髁-胫骨膝关节骨关节炎（OA）患者的临床效果。
为期6个月的前瞻性随机对照研究。
股骨内侧髁-胫骨膝关节OA疼痛的门诊患者。
患者对疾病活动的总体评估（5级量表）、WOMAC指数子量表及伴随治疗情况。
采用意向性分析。主要标准：患者对活动评估的改善（定义为与基线相比在第6个月时降低1级或更多，且研究期间未进行关节内注射或灌洗）。次要评估标准：（a）与基线相比在第1个月和第3个月时患者对活动评估的改善；（b）与基线相比在第1个月、第3个月和第6个月时WOMAC子量表的改善（定义为至少改善30%，且研究期间未进行关节内注射或灌洗）；（c）伴随治疗（镇痛药和非甾体抗炎药）。
156例纳入患者（41例男性，115例女性，平均年龄64.8岁）的基线特征在两个治疗组中无差异。在第1个月、第3个月和第6个月时，两组中疾病活动评估、WOMAC疼痛、关节僵硬和身体功能子量表改善的患者百分比相似。与基线相比，在第6个月时，使用外侧楔形鞋垫组在前3个月内服用非甾体抗炎药的天数减少（14.1天±28天 vs 9.9天±27天，P = 0.04，Wilcoxon配对检验），而另一组保持不变（15.5天±24天 vs 15天±28天，P = 0.56）。依从性和耐受性良好。在第6个月时两组的依从性不同，外侧楔形鞋垫组中永久佩戴鞋垫的患者频率高于另一组（87.8% vs 74.3%；P = 0.032）。
本研究未能证明外侧楔形鞋垫对股骨内侧髁-胫骨OA有显著的短期症状改善作用。然而，治疗组中非甾体抗炎药消耗量的减少以及更好的依从性有利于外侧楔形鞋垫对股骨内侧髁-胫骨OA产生有益效果。
