Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus

TANG Jiaming; HUANG Jihan; YANG Xuming; ZHANG Qian; ZHENG Fengzhou; LI Jing; LU Wang; XUE Kun; ZHAO Haiyin

doi:10.16305/j.1007-1334.2019.01.015

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Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus

更新时间：2022-08-31

- Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus
- Shanghai Journal of Traditional Chinese Medicine Vol. 53, Issue 1, Pages: 55-61(2019)
- 作者机构：
  
  1. 上海中医药大学实验动物中心,上海,201203
  2. 上海中医药大学药物临床研究中心,上海,201203
  3. 上海中医药大学针推学院,上海,201203
  4. 上海中医药大学附属岳阳中西医结合医院针灸科,上海,200437
  5. 上海中医药大学附属龙华医院中医传统治疗部,上海,200032
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2019.01.015
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TANG Jiaming, HUANG Jihan, YANG Xuming, et al. Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus. [J]. Shanghai Journal of Traditional Chinese Medicine 53(1):55-61(2019)
DOI：

TANG Jiaming, HUANG Jihan, YANG Xuming, et al. Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus. [J]. Shanghai Journal of Traditional Chinese Medicine 53(1):55-61(2019) DOI： 10.16305/j.1007-1334.2019.01.015.

摘要

目的：以传统艾灸疗法为对照,采用电子温灸仪(DZWJY-1型)治疗膝骨关节炎,评价该仪器的临床疗效及安全性。方法：将124例膝骨关节炎患者随机分为电子温灸仪组与传统艾灸组,每组62例。电子温灸仪组采用DZWJY-1型电子温灸仪治疗,传统艾灸组采用传统艾灸疗法。两组疗程均为4周,观察临床疗效及安全性,比较膝痛VAS评分、WOMAC评分(总分及分项评分)的变化情况。结果：①试验期间,电子温灸仪组完成试验60例,脱落2例；传统艾灸组完成试验58例,脱落3例,剔除1例。②FAS分析结果显示,电子温灸仪组的显效率为75.81%、有效率为91.94%,传统艾灸组的显效率为68.85%、有效率为90.16%；组间临床疗效比较,差异无显著统计学意义(P>0.05)。电子温灸仪组与传统艾灸组有效率差值的95%可信区间为-9.05～12.77,按照预设15%非劣标准,非劣效检验合格。③治疗前及治疗2周、治疗4周组内分别比较,两组膝痛VAS评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,膝痛VAS评分差异均无统计学意义(P>0.05)。④治疗前及治疗2周、治疗4周组内分别比较,两组WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均无统计学意义(P>0.05)。⑤两组不良反应发生率均为0%。结论：电子温灸仪(DZWJY-1型)治疗膝骨关节炎的临床疗效不劣于传统艾灸疗法,可明显缓解疼痛,改善关节功能。

Abstract

Objective:To evaluate efficacy and safety of DZWJY - type 1 electronic moxibustion apparatus in treating patients of knee osteoarthritis with traditional moxibustion therapy as control. MethodsOne hundred and twenty-four patients with knee osteoarthritis were randomly divided intoelectronic moxibustion group and traditional moxibustion group with 62 cases in each group. The electronic moxibustion group was treated with DZWJY-1 electronic moxibustion apparatus,and the traditional moxibustion group with traditional moxibustion therapy. The course of treatment in both groups was 4 weeks. The clinical efficacy and safety were observed and the changes of VAS score,WOMAC score (total score and sub-score) of knee pain were compared between the two groups. Results:①The remarkably effective rate was 75.81% and the effective rate was 91.94%% in the electronic moxibustion group,and the remarkably effective rate was 68.85% and the effective rate was 90.16% in the traditional moxibustion group. There was no significant difference between the two groups (P>0.05). The 95% confidence interval of the effective rate difference between the electronic moxibustion group and the traditional moxibustion group was -9.05－12.77. According to the 15% non-inferiority standard,the non-inferiority test was qualified.②There were significant differences in VAS scores between the two groups before and after 2 weeks and 4 weeks of treatment (P<0.01). But there was no significant difference in VAS score of knee pain between the two groups after 2 weeks and 4 weeks of treatment (P>0.05).③There were significant differences in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups before and after treatment for 2 weeks and 4 weeks (P<0.01). There was no significant difference in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups after 2 weeks and 4 weeks of treatment (P>0.05). ④There were no adverse reactions occurring in both groups. Conclusion:The clinical effect of electronic moxibustion apparatus (DZWJY-1) in the treatment of knee osteoarthritis is not inferior to that of traditional moxibustion therapy,which can obviously relieve pain and improve joint function.

关键词

电子温灸仪膝骨关节炎临床试验膝痛膝关节功能艾灸标准化

Keywords

electronic moxibustion apparatusknee arthritisclinic trialknee painknee joint functionstandardization of moxibustion

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