Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis: a prospective randomized controlled study
Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis: a prospective randomized controlled study
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DOI：
10.1053/joca.2001.0470
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发表时间：
2001-11-01
影响因子：
7
通讯作者：
Dougados, M
中科院分区：
文献类型：
--
作者：
Maillefert, JF;Hudry, C;Dougados, M
目的：比较外侧楔形鞋垫和中性楔形鞋垫（用作对照）对股骨胫骨内侧膝骨关节炎（OA）患者的临床效果。设计：为期 6 个月的前瞻性随机对照研究。患有疼痛的内侧股骨-胫骨膝关节 OA 的门诊患者。结果测量：患者对疾病活动性的总体评估（5 级量表）、WOMAC 指数子量表和伴随治疗。统计分析：作为意向治疗分析进行。主要标准：患者活动评估的改善（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，第 1 个月和第 3 个月患者的活动评估有所改善，(b) 与基线相比，第 1、3 和 6 个月的 WOMAC 分量表有所改善（定义为改善至少 30%，并且研究期间没有关节内注射或灌洗），以及 (c) 伴随治疗（镇痛药和 NSAID）。 结果：156 名招募患者的基线特征（41 名男性，115 名女性，平均年龄 64.8 岁）在两个治疗组中没有差异。在第 1、3 和 6 个月时，两组的疾病活动评估、WOMAC 疼痛、关节僵硬和身体功能分量表有所改善的患者百分比相似。与基线相比，配备侧向楔形鞋垫的组在前 3 个月中摄入 NSAID 的天数在第 6 个月有所减少（14.1 天 +/- 28 与 9.9 天 +/- 27，P=0.04，Wilcoxon 配对测试），而另一组则保持不变（15.5 天 +/- 24 与 15 +/- 28，P=0.56）。依从性和耐受性令人满意。第 6 个月时，两组的依从性不同，外侧楔形鞋垫组永久穿着鞋垫的患者频率高于另一组（87.8% vs 74.3%；P=0.032）。结论：这项研究未能证明外侧楔形鞋垫对股骨内侧-胫骨 OA 的相关短期症状影响。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侧向楔形鞋垫在股骨-胫骨内侧骨关节炎中的有益作用。 (C) 2001 年国际骨关节炎研究协会。
Objective: 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).Design: 6-month prospective randomized controlled study. Patients outpatients with painful medial femoro-tibial knee OA.Outcome measures: patient's overall assessment of disease activity (5 grade scale), WOMAC index subscales and concomitant treatments.Statistical analysis: 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 intrarticular injection or lavage during the study) and (c) concomitant therapies (analgesics and NSAIDs).Results: 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).Conclusion: 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. (C) 2001 OsteoArthritis Research Society International.