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[1]袁啟令,劉亮,馬江濤,等.針刺治療慢性非特異性腰痛的臨床研究[J].中醫(yī)正骨,2016,28(06):12-17.
　YUAN Qiling,LIU Liang,MA Jiangtao,et al.A clinical study of acupuncture therapy for treatment of chronic nonspecific low back pain[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(06):12-17.
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針刺治療慢性非特異性腰痛的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期數(shù):
2016年06期
頁碼:
12-17
欄目:
臨床研究
出版日期:
2016-06-20

文章信息/Info

Title:
A clinical study of acupuncture therapy for treatment of chronic nonspecific low back pain
作者:
袁啟令1; 劉亮1; 馬江濤2; 武文韜1; 葉茂林2; 張銀剛1
1.西安交通大學(xué)第一附屬醫(yī)院,陜西 西安 710061;
2.河南中醫(yī)藥大學(xué),河南 鄭州 450008
Author(s):
YUAN Qiling1; LIU Liang1; MA Jiangtao2; WU Wentao1; YE Maolin2; ZHANG Yingang1
1.The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,Shanxi,China
2.Henan University of Traditional Chinese Medicine,Zhengzhou 450008,Henan,China
關(guān)鍵詞:
腰痛;  針刺療法;  安慰針刺;  臨床試驗(yàn)
Keywords:
low back pain;  acupuncture therapy;  sham acupuncture;  clinical trial
摘要:
目的:探討針刺對于慢性非特異性腰痛的特異性治療作用。方法:采用前瞻性、隨機(jī)、單盲、安慰對照、平行、多中心研究。共納入150例慢性非特異性腰痛患者,隨機(jī)分配至針刺組、安慰針刺組和等待治療組,每組50例。治療時(shí)針刺組選擇腎俞、大腸俞、委中、腰陽關(guān)、環(huán)跳5個(gè)穴位為固定針刺點(diǎn),同時(shí)在腕骨、帶脈、陽陵泉、足臨泣、地倉、足三里、命門、懸樞、神庭、水溝10個(gè)穴位中靈活選取幾個(gè)穴位進(jìn)行針刺治療,進(jìn)針5～20 mm,得氣后留針20 min。隔2 d治療1次,共治療6周。安慰針刺組選取與針刺組相同的5個(gè)固定穴位用安慰針灸針進(jìn)行治療,療程與針刺組相同; 等待治療組在本試驗(yàn)期間不接受治療,待本試驗(yàn)結(jié)束后再接受針刺治療。所有患者在必要的情況下,允許口服非甾體類抗炎藥緩解腰痛。主要觀察指標(biāo)包括腰部疼痛視覺模擬評分量表(visual analogue scale,VAS)評分和Oswestry功能障礙指數(shù)(Oswestry disability index,ODI),觀察時(shí)點(diǎn)設(shè)為針刺組和安慰針刺組治療前和治療結(jié)束后1、4、12周。同時(shí)觀察并發(fā)癥發(fā)生率,評價(jià)試驗(yàn)的盲法質(zhì)量。結(jié)果:共有14例患者未完成試驗(yàn)觀察,其中針刺組4例、安慰針刺組4例、等待治療組6例。針刺組和安慰針刺組共有17例患者報(bào)告了24次小至中度的與治療有關(guān)的不良反應(yīng),不良反應(yīng)持續(xù)時(shí)間均不超過1周。2組不良反應(yīng)發(fā)生率比較,差異無統(tǒng)計(jì)學(xué)意義(χ2=0.071,P=0.790)。治療結(jié)束后,針刺組和安慰針刺組患者均接受了盲法評估。2組患者的評估結(jié)果比較,差異無統(tǒng)計(jì)學(xué)意義(χ2=0.230,P=0.891)。治療前后不同時(shí)間腰痛VAS評分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=34.590,P=0.000); 除等待治療組外(P=0.054),治療結(jié)束后1周針刺組和安慰針刺組腰痛VAS評分均小于治療前(P=0.000,P=0.000); 治療結(jié)束后4、12周,針刺組、安慰針刺組和等待治療組的腰痛VAS評分均小于治療前(P=0.000,P=0.000,P=0.002; P=0.000,P=0.000,P=0.000)。3組腰痛VAS評分總體上比較,組間差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=22.340,P=0.000); 治療前和治療結(jié)束后12周3組腰痛VAS評分比較,組間差異均無統(tǒng)計(jì)學(xué)意義(F=1.073,P=0.345; F=1.666,P=0.192); 治療結(jié)束后1周,針刺組腰痛VAS評分小于安慰針刺組和等待治療組(P=0.004,P=0.000),安慰針刺組腰痛VAS評分小于等待治療組(P=0.010); 治療結(jié)束后4周,針刺組腰痛VAS評分小于安慰針刺組和等待治療組(P=0.008,P=0.000),安慰針刺組腰痛VAS評分小于等待治療組(P=0.030)。時(shí)間因素與分組因素存在交互效應(yīng)(F=3.760,P=0.025)。治療前后不同時(shí)間ODI評分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=68.020,P=0.000); 治療結(jié)束后1、4、12周,針刺組、安慰針刺組和等待治療組的ODI評分均小于治療前(P=0.000,P=0.000,P=0.000; P=0.000,P=0.000,P=0.000; P=0.000,P=0.000,P=0.000)。3組ODI評分總體上比較,組間差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=14.390,P=0.000); 治療前和治療結(jié)束后12周3組評分比較,組間差異均無統(tǒng)計(jì)學(xué)意義(F=0.815,P=0.444; F=0.431,P=0.651); 治療結(jié)束后1周,針刺組評分小于安慰針刺組和等待治療組(P=0.001,P=0.000),安慰針刺組與等待治療組比較,差異無統(tǒng)計(jì)學(xué)意義(P=0.124); 治療結(jié)束后4周,針刺組評分與安慰針刺組比較,差異無統(tǒng)計(jì)學(xué)意義(P=0.127),針刺組和安慰針刺組評分均小于等待治療組(P=0.000,P=0.001)。時(shí)間因素與分組因素不存在交互效應(yīng)(F=1.800,P=0.169)。結(jié)論:針刺對于慢性非特異性腰痛存在特異性治療作用,可在短期內(nèi)(≤4周)緩解患者腰部疼痛癥狀、改善腰部功能,而且具有較高的安全性。
Abstract:
Objective:To explore the specific therapeutic effect of acupuncture therapy on chronic nonspecific low back pain.Methods:A prospective,randomized,single-blinded,placebo-controlled,parallel,multicenter trial was carried out.One hundred and fifty patients with chronic nonspecific low back pain were included and randomly divided into acupuncture group,placebo-acupuncture group and wait-to-treat group,50 cases in each group.The patients in acupuncture group were treated with acupuncture therapy and five acupoints including Shenshu(BL23),Dachangshu(BL25),Weizhong(BL40),Yaoyangguan(GV3)and Huantiao(GB30)were selected as fixed acupuncture points.Meanwhile,several points were selected for acupuncture treatment from 10 acupoints including Wangu(SI4),Daimai(GB26),Yanglingquan(GB34),Zulinqi(GB41),Dicang(ST4),Zusanli(ST36),Mingmen(GV4),Xuanshu(GV5),Shenting(GV24)and Shuigou(GV26)according to the specific conditions.The depth of needle insertion was 5-20 mm and the needles were retained for 20 mintues at a time after DEQI(GETTING QI).The acupuncture was performed every 3 days for consecutive 6 weeks.The patients in placebo-acupuncture group were treated with placebo-acupuncture therapy by selecting the same 5 acupoints as that of acupuncture group and the course of treatment was also same as that of acupuncture group.The patients in wait-to-treat group were not treated until the end of this trial.All of the patients were permitted to take nonsteroidal anti-inflammatory drugs(NSAID)for relieving low back pain if necessary.Low back pain visual analogue scale(VAS)scores and Oswestry disability index(ODI)were used as main indexes for measuring the treatment effectiveness before the treatment and at 1,4 and 12 weeks after the end of the treatment.Meanwhile,the complication rates were observed and the quality of blind method used in the trail was evaluated.Results:The experimental observation were unfinished in 14 patients,4 patients in acupuncture group,4 patients in placebo-acupuncture group and 6 patients in wait-to-treat group.A total of 17 patients in acupuncture group and placebo-acupuncture group reported mild-to-moderate adverse reactions related to treatment for 24 times,no more than 1 week at a time.There was no statistical difference in the incidence rate of adverse reactions between the 2 groups(χ2=0.071,P=0.790).The blind method was evaluated in the patients in acupuncture group and placebo-acupuncture group after the end of the treatment and there was no statistical difference in the evaluation results between the 2 groups(χ2=0.230,P=0.891).There was statistical difference in low back pain VAS scores between different time points,in other words,there was time effect(F=34.590,P=0.000).The low back pain VAS scores were lower at 1 week after the end of the treatment compared to pre-treatment in acupuncture group and placebo-acupuncture group(P=0.000,P=0.000),while there was no statistical difference between pre-treatment and post-treatment in wait-to-treat group(P=0.054).The low back pain VAS scores were lower at 4 and 12 weeks after the end of the treatment compared to pre-treatment in all of the 3 groups(P=0.000,P=0.000,P=0.002; P=0.000,P=0.000,P=0.0000).There was statistical difference in low back pain VAS scores between the 3 groups in general,in other words,there was group effect(F=22.340,P=0.000).There was no statistical difference in low back pain VAS scores between the 3 groups before treatment and at 12 weeks after the end of the treatment(F=1.073,P=0.345; F=1.666,P=0.192).The low back pain VAS scores were lower in acupuncture group compared to placebo-acupuncture group and wait-to-treat group and were lower in placebo-acupuncture group compared to wait-to-treat group at 1 week after the end of the treatment(P=0.004,P=0.000,P=0.010).The low back pain VAS scores were lower in acupuncture group compared to placebo-acupuncture group and wait-to-treat group and were lower in placebo-acupuncture group compared to wait-to-treat group at 4 weeks after the end of the treatment(P=0.008,P=0.000,P=0.030).There was interaction between time factor and group factor(F=3.760,P=0.025).There was statistical difference in ODI scores between different time points,in other words,there was time effect(F=68.020,P=0.000).The ODI scores were lower at 1,4 and 12 weeks after the end of the treatment compared to pre-treatment in all of the 3 groups(P=0.000,P=0.000,P=0.000; P=0.000,P=0.000,P=0.000; P=0.000,P=0.000,P=0.000).There was statistical difference in ODI scores between the 3 groups in general,in other words,there was group effect(F=14.390,P=0.000).There was no statistical difference in ODI scores between the 3 groups before treatment and at 12 weeks after the end of the treatment(F=0.815,P=0.444; F=0.431,P=0.651).The ODI scores were lower in acupuncture group compared to placebo-acupuncture group and wait-to-treat group at 1 week after the end of the treatment(P=0.001,P=0.000),and there was no statistical difference in ODI scores between placebo-acupuncture group and wait-to-treat group(P=0.124).There was no statistical difference in ODI scores between acupuncture group and placebo-acupuncture group at 4 weeks after the end of the treatment(P=0.127).The ODI scores were lower in acupuncture group and placebo-acupuncture group compared to wait-to-treat group(P=0.000,P=0.001).There was no interaction between time factor and group factor(F=1.800,P=0.169).Conclusion:Acupuncture therapy has specific therapeutic effect on chronic nonspecific low back pain,it can relieve low back pain and improve lumbar function in short term(≤4 weeks),meanwhile it has high safety.

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備注/Memo

備注/Memo:
基金項(xiàng)目:國家自然科學(xué)基金項(xiàng)目1371987,81171761); 陜西省科技計(jì)劃項(xiàng)目(2013K12-14-04)
通訊作者:張銀剛 E-mail:[email protected]
更新日期/Last Update: 2016-06-30