摘要
目的：
本研究旨在客观评价针刺配合艾灸治疗颈椎病颈痛的即时、近期和远期疗效,探讨针刺配合艾灸治疗颈椎病颈痛的临床有效性。
方法：
研究时间是从2011年1月至2012年2月。受试者大部分来自广东省中医院各分院门诊,部分从社区招募。
本研究采用临床随机对照试验设计,共设针灸治疗组(针灸组)、针刺对照组(针刺组)、灸法对照组(灸法组)三个组。应用华西医科大学的PEMS3.1统计软件进行样本量估算,共需病例150例,每组50例。采取简单随机化方法,把估算的样本含量输入统计软件包PEMS3.1,得出顺序号,制作随机卡片,加信封密封。合格病例进入试验时,根据具体进入的先后次序按信封上的序号顺序拆开信封,依照随机卡片上的提示进行分组。
治疗方案：针灸组首先采用针刺治疗,出针后进行艾灸治疗；针刺组采用单纯针刺治疗；艾灸组采用单纯艾灸治疗。三组选穴相同,均为双侧颈百劳,大椎,双侧肩中俞,双侧中渚。针刺操作：定穴消毒,采用直径0.30mm的一次性管针直刺入穴位,深度依穴位部位,每个穴位均运针至得气为度,留针20分钟。艾灸操作：将艾绒制作成麦粒大小的艾炷(约为高5mm,底直径3mm的圆锥体)。在选定的穴位上涂以万花油,放上艾炷并点燃,当病人难以耐受艾炷的灼痛感时将艾炷移开,每个穴位灸5壮,施灸穴位以皮肤潮红效最佳。每3天治疗1次,两次治疗时间间隔在48-72小时之间,每周完成2-3次治疗,10次为1疗程,4周内完成,1疗程结束后观察疗效。
评价指标：采用Northwick Park颈痛量表(NPQ)作为主要评价指标,和颈部压痛阈(PPT)、McGill简式量表(MPQ)、SF-36普适性量表(SF-36)和有效率作为次要评价指标。PPT采用压痛测量仪测量,测试者先用手指按压颈部肌肉寻找压痛点,并做好标记,然后用压力测试探头按于此压痛点上逐渐加压,被测试者感到受力部位疼痛时,按下用压痛开关锁定一个压力数值,此压力值即为PPT。
采集时点：NPQ、 MPQ在治疗前、第5次治疗结束时、疗程结束时、随访1个月时及随访3个月时5各时点进行采集。SF-36在治疗前、疗程结束时、随访1个月时及随访3个月时4各时点进行采集。PPT在每次治疗前后进行采集。
疗效评价：以每次治疗前后PPT差值评价三组治疗方案的即时止痛效果。以疗程结束后的NPQ、 MPQ、 SF-36和有效率评价三组治疗方案的近期治疗效果。以随访3个月后的NPQ、 MPQ、 SF-36和有效率评价三组治疗方案的远期治疗效果。
数据管理与统计分析：将采集的数据,应用Epidata建立数据库,采用SPSS18.0统计软件进行分析,分析方法包括描述性统计,卡方检验,组内自身前后比较及组间比较t检验,秩和检验等。
结果：
1.基线资料
三组患者在性别构成、是否具有长期低头习惯,患者的受教育程度分布情况以及之前是否有接受过针灸治疗经历等方面比较差异均无统计学意义(P>0.05)；三组患者的年龄、病程和日常平均低头工作时间比较差异亦无统计学意义(P>0.05)。证候分布方面,三组患者证候均以风寒湿型和气滞血瘀型为主。颈椎病诊断分型方面,三组患者在颈椎病亚型分布上差异无统计学意义(P>0.05)。
三组患者的NPQ量表得分、MPQ量表得分、压痛阈基线相等(P>0.05),SF-36中8个维度的测量指标基线也相等(P>0.05)。
2.NPQ量表
治疗五次后三组NPQ得分,针灸组为24.9±8.0,针刺组为27.3±7.7,灸法组为28.6±7.0,针灸组与灸法组比较差异具有统计学意义(P<0.05),针灸组与针刺组以及针刺组与灸法组比较差异无统计学意义(P>0.05)。
治疗结束后三组患者NPQ得分,针灸组为15.9±4.7,针刺组为18.2±5.0,灸法组为20.2±4.5,针灸组与灸法组、针灸组与针刺组、针刺组与灸法组比较差异均具有统计学意义(P<0.05)。
随访1个月时三组NPQ得分,针灸组为17.4±4.3,针刺组为21.6±3.8,灸法组为22.0±3.8,针灸组与针刺组比较以及针灸组与灸法组比较差异均具有统计学意义(P<0.05),针刺组与灸法组差异无统计学意义(P>0.05)。
随访3个月后三组NPQ得分,针灸组为21.9±4.1,针刺组为26.5±3.2,灸法组为25.8±3.2,针灸组与针刺组比较以及针灸组与灸法组比较差异均具有统计学意义(P<0.05),针刺组与灸法组差异无统计学意义(P>0.05)。
2.2压痛阈
第一次治疗前后压痛阈差值,针灸组0.39±0.13,针刺组0.28±0.07,灸法组0.17±0.03,三组间两两比较均具有统计学意义(P<0.01)。
第二次治疗前后压痛阈差值,针灸组0.36±0.10,针刺组0.35±0.08,灸法组0.30±0.05,灸法组与针刺组以及灸法组与针灸组比较均具有统计学意义(P<0.01),针灸组与针刺组比较差异无统计学意义(P>0.05)。
第三次治疗前后差值,针灸组0.51±0.14,针刺组0.48±0.12,灸法组0.38±0.07,灸法组与针刺组以及灸法组与针灸组比较均具有统计学意义(P<0.01)。
第四次治疗前后差值,针灸组0.62±0.19,针刺组为0.52±0.12,灸法组为0.39±0.07,三组间两两比较均具有统计学意义(P<0.01)。
第五次治疗前后差值,针灸组为0.50±0.20,针刺组0.53±0.14,灸法组0.43±0.08,灸法组与针刺组以及灸法组与针灸组比较均具有统计学意义(P<0.05),针灸组与针刺组比较差异无统计学意义(P>0.05)。
第六次治疗前后差值,针灸组0.45±0.18,针刺组0.41±0.11,灸法组0.47±0.09,灸法组与针刺组比较差异有统计学意义(P<0.05),针灸组与针刺组比较以及针灸组与灸法组比较差异均无统计学意义(P>0.05)。
第七次治疗前后差值,针灸组0.31±0.15,针刺组0.34±0.09,灸法组0.39±0.09,灸法组与针刺组以及灸法组与针灸组比较均具有统计学意义(P<0.05),针灸组与针刺组比较差异无统计学意义(P>0.05)。
第八次治疗前后差值,针灸组0.20±0.15,针刺组0.27±0.08,灸法组0.28±0.07,针灸组与针刺组比较以及针灸组与灸法组比较差异均具有统计学意义(P<0.01),针刺组与灸法组比较差异无统计学意义(P>0.05)。
第九次治疗前后差值,针灸组0.14±0.12,针刺组0.25±0.07,灸法组0.22±0.06,针灸组与针刺组、针灸组与灸法组比较差异均具有统计学意义(P<0.01)。
第十次治疗前后差值,针灸组0.10±0.05,针刺组0.14±0.04,灸法组0.17±0.03,三组间两两比较均具有统计学意义(P<0.01)。
2.3MPQ量表
治疗5次后三组MPQ得分,针灸组9.0±2.4,针刺组9.4±2.3,灸法组10.1±2.3,针灸组与灸法组比较差异有统计学意义(P<0.05),针灸组与针刺组比较以及针刺组与灸法组比较差异均无统计学意义(P>0.05)。
疗程结束时三组MPQ得分,针灸组3.3±2.4,针刺组4.7±2.5,灸法组5.3±2.5,针灸组与针刺组以及针灸组与灸法组比较差异有统计学意义(以0.05),针刺组与灸法组比较无统计学意义(P>0.05)。
随访1个月后,针灸组4.8±2.3,针刺组6.8±2.0,灸法组7.0±1.9,针灸组与针刺组以及针灸组与灸法组比较差异有统计学意义(P<0.05),针刺组与灸法组比较无统计学意义(P>0.05)。
随访3个月后,针灸组7.5±2.2,针刺组10.2±1.8,灸法组9.8±1.5,针灸组与针刺组以及针灸组与灸法组比较差异有统计学意义(P<0.05),针刺组与灸法组比较无统计学意义(P>0.05)。
2.4SF-36量表
在疗程结束时,生理机能维度得分,针灸组87.2±7.7,针刺组83.8±6.3,灸法组82.1±4.3；生理职能维度,针灸组94.1±15.8,针刺组87.7±17.1,灸法组84.0_±16.8；躯体疼痛维度,针灸组77.1±9.4,针刺组74.2±9.9,灸法组69.6±7.0；精力维度,针灸组55.6±7.1,针刺组52.1±7.5,灸法组53.5±7.2。生理机能、生理职能、躯体疼痛、精力维度4个维度三组差异有统计学意义(P<0.05)。经多元方差分析,在生理机能、生理职能、躯体疼痛3维度针灸组疗效优于灸法组(P<0.05)；在生理机能、精力维度维度针灸组疗效优于针刺组(P<0.05)；在躯体疼痛维度针刺组疗效优于灸法组(P<0.05)。一般健康状况、社会功能、情感职能、精神健康4维度三组比较差异无统计学意义(P>0.05)。
随访1个月时,生理机能维度得分,针灸组83.5±7.1,针刺组80.1±5.1,灸法组79.5±4.4；躯体疼痛维度得分,针灸组69.7±6.8,针刺组67.9±5.9,灸法组66.0±6.1；精力维度得分,针灸组53.8±6.7,针刺组49.4±6.3,灸法组49.6±7.8；情感职能维度,针灸组75.8±20.5,针刺组68.0±±13.8,灸法组62.4±20.4；精神健康维度,针灸组49.7±8.9,针刺组46.1±7.4,灸法组45.3±7.4,在以上5个维度三组患者评分差距有统计学意义(P<0.05)。经多元方差分析,在生理机能、躯体疼痛、精力、情感职能、精神健康维度,针灸组疗效优于灸法组(P<0.05)；在生理机能、精力、情感职能、精神健康4维度,针灸组疗效优于针刺组(P<0.05)。生理职能、一般健康状况、社会功能3个维度三组比较差异无统计学意义(P>0.05)。
随访3个月时,生理机能维度得分,针灸组80.7±5.3,针刺组77.3±4.4,灸法组77.7±4.0；生理职能维度,针灸组59.0±±13.2,针刺组48.9±7.2,灸法组54.2±13.1；躯体疼痛维度,针灸组66.2±7.7,针刺组61.7±7.6,灸法组61.1±7.4；情感职能维度,针灸组60.9±18.8,针刺组50.3±21.8,灸法组56.0±±20.9,在以上4个维度三组患者评分差距有统计学意义(P<0.05)。经多元方差分析,在生理机能、生理职能、躯体疼痛维度,针灸组疗效优于灸法组(P<0.05)：在生理机能、生理职能、躯体疼痛、情感职能维度,针灸组疗效优于针刺组(P<0.05)；在生理职能维度灸法组疗效优于针刺组(P<0.05)。一般健康状况、精力、社会功能、精神健康4维度三组比较差异无统计学意义(P>0.05)。
2.5有效率
NPQ评分下降5分以上即具有临床意义。在疗程结束时,根据各组NPQ减分情况计算有效率,以评价近期疗效。随访3个月时,评价各组远期疗效。疗程结束时,针灸组有效率为91.8%,针刺组为89.4%,灸法组为85.4%,经卡方检验,三组有效率两两比较差异均无统计学意义(P>0.05)。随访3个月时,针灸组有效率89.8%,针刺组79.2%,灸法组81.3%,三组有效率两两比较差异均无统计学意义(P>0.05)。故认为针灸组、针刺组和灸法组治疗颈椎病颈痛均有较好的近期、远期疗效。
结论：
1.针刺配合艾灸治疗颈椎病颈痛,具有较好的即时止痛效果、近期疗效和远期疗效。
2.针刺配合艾灸治疗方案,不仅能缓解颈椎病颈痛患者躯体上的疼痛,而且能全面改善患者的生存质量。
Objective
This study aimed to assess the therapeutic effect of acupuncture combined with moxibustion on neck pain. On this basis, to obtain a clinical protocol which can improve both the short and the long term effects of acupuncture and moxibustion on neck pain.
Methods
Research time is between January2011and February2012. Most of the patients came from Outpatient Clinics of branch courts of Guangdong Hospital of TCM. Others were recruited from community.
This study was a randomized controlled clinical trial.3groups were set, including acupuncture combined with moxibustion(AMG) treatment group, pure acupuncture treatment group(AG) and pure moxibustion treatment group(MG). PEMS3.1statistical software was used to estimate the sample size. Over operation,150cases of neck pain were determined and50cases in each group. Simple random method was used in this research. First, input the sample size into the PEMS3.1statistical package obtaining sequence random number. Then, make random cards and enclose the cards into envelopes. When trials, unfold the envelope in sequence, Follow the prompts to determine which group the subject was.
AMG used acupuncture first, after needles, followed by moxibustion. AG used acupuncture treatment only. MG used moxibustion treatment only. All of the three groups used the same acupoints, Dazhui (GV14), bilateral Jingbailao (EX-HN15), bilateral Jianzhongshu(SI15), and bilateral Zhongzhu(TE3). When acupuncture operation, disinfected acupoints firstly, then punched the acupoints with0.30mm diameter disposable needle tube. The depth of the needle would be determined by the acupoints themselves and the sensation of De Qi. Place the needles in their place for20minutes. When moxibustion treatment, moxa cone should be prepared first (a conicalness like grain size that about5mm high and3mm long at the bottom). After ready, put the moxa cone onto the acupoints coated with WanHua oil and lighted. When unbearale causalgia was felt moved the moxa cone away. Repeat5times for each acupoint. Treating every other day, time interval between two treatments was48-72hours,2to3times a week, and10times is one treating cause. All of the treatments should be completed in4weeks, one cause later, observed the therapeutic effect.
The main evaluation indicator is Northwick Park Neck Pain Questionnaire (NPQ), and McGill Pain Questionnaire (MPQ), Short Form36-items Health Survey (SF-36) and Pressing Pain Threshold in neck(PPT) are secondary evaluation indicators. PPT was measured by a pressing pain admeasure apparatus. When measured, searched tender points with your finger in neck muscles first, then marked the most tender one and put the pressure test probe on it. As the operator pressed the point with gradually increased strength, the display device showed the number of the pressure. When pressing pain was felt, the subject pressed down the button immediately and the PPT would be read.
NPQ and MPQ was collected before treatment, after the fifth treatment, after the tenth treatment, after one month follow-up and after three months follow-up. SF-36was collected before treatment, after the tenth treatment, after one month follow-up and after three months follow-up. PPT was collected before and after treatment.
The change of PPT in each treatment was used to assess the instant analgesic effect. Data of NPQ, MPQ and SF-36after the tenth treatment was used to assess the short term effect. Data of NPQ, MPQ and SF-36after three months follow-up was used to assess the long terrm effect.
Established database by Epidata and analyze the data using SPSS18.0software. Analyzing methods include descriptive statistics, chi-square test, t test and rank sum test.
Results
1. Baseline Data
There is no difference in three groups before treatment, including Age, Gender Composition, Long-Term Head Drop or Not, Duration of Head Drop, Educational Level, Course of Disease, and Acupuncture Treatment Experience (P>0.05).
The main symptoms are wind-cold-dampness symptom and qi stagnancy and blood stasis symptom. There is no difference in three groups in diagnosis of cervical vertebra disease classification (P>0.05).
There is no difference in three groups in NPQ, MPQ, PPT and SF-36before treatment (P>0.05).
2. Northwick Park Neck Pain Questionnaire(NPQ)
The Scores of NPQ, after five times treating, are AMG24.9±8.0, AG27.3±7.7, MG28.6±7.0. There is statistically significant difference between AMG and MG(P<0.05). Score of NPQ of AMG is lower than that of MG. There are no statistically significant differences between AMG and AG(P>0.05) and between AG and MG(P>0.05).
The Scores of NPQ, after ten times treating, are AMG15.9±4.7, AG18.2±5.0, MG20.2±4.5. There are statistically significant differences between the three groups (P<0.05). Score of NPQ of AMG is the lowest. Score of NPQ of AG is lower than that of MG.
The Scores of NPQ, after one month follow-up, are AMG17.4±+4.3, AG21.6±3.8, MG22.0±3.8. There are statistically significant differences between AMG and AG (P<0.05) and between AMG and MG (P<0.05). Score of NPQ of AMG is the lowest. There is no statistically significant difference between AG and MG (P>0.05).
The Scores of NPQ, after three months follow-up, are AMG21.9±4.1,AG26.5±3.2, MG25.8±3.2. There are statistically significant differences between AMG and AG (P<0.05) and between AMG and MG (P<0.05). Score of NPQ of AMG is the lowest. There is no statistically significant difference between AG and MG (P>0.05).
3. Pressing Pain Threshold (PPT)
There are differences between the three groups in the D-values of PPT (D-PPT) before and after every time treating.
The D-PPT of three groups in the first time are AMG0.39+0.13, AG0.28±0.07, MG0.17±0.03. There are statistically significant differences between the three groups (P<0.01).
The D-PPT of three groups in the second time are AMG0.36±0.10, AG0.35±0.08, MG0.30±0.05. There are statistically significant differences between AMG and MG (P<0.01) and MG and AG (P<0.01). There is no statistically significant differences between AMG and AG (P>0.05).
The D-PPT of three groups in the third time are AMG0.51±0.14, AG0.48±0.12, MG0.38±0.07. There are statistically significant differences between AMG and MG (P<0.01) and MG and AG (P<0.01). There is no statistically significant differences between AMG and AG (P>0.05).
The D-PPT in fourth time are AMG0.62±0.19, AG0.52±0.12, MG0.39±0.07. There are statistically significant differences between the three groups (P<0.01).
The D-PPT of three groups in the fifth time are AMG0.50±0.20, AG0.53±0.14, MG0.43±0.08. There are statistically significant differences between AMG and MG (P<0.01) and MG and AG (P<0.05). There is no statistically significant differences between AMG and AG (P>0.05).
The D-PPT of three groups in the sixth time are AMG0.45±0.18, AG0.41±0.11, MG0.47±0.09. There are statistically significant differences between MG and AG (P<0.05). There are no statistically significant differences between AMG and AG (P>0.05) and AMG and MG (P>0.05).
The D-PPT of three groups in the seventh time are AMG0.31±0.15, AG0.34±0.09, MG0.39±0.09. There are statistically significant differences between MG and AG (P<0.05) and MG and AMG. There is no statistically significant differences between AMG and AG (P>0.05).
The D-PPT of three groups in the eighth time are AMG0.20±0.15, AG0.27±0.08, MG0.28±0.07. There are statistically significant differences between AMG and AG (P<0.01) and AMG and MG (P<0.01). There is no statistically significant differences between MG and AG (P>0.05).
The D-PPT of three groups in the ninth time are AMG0.14±0.12, AG0.25±0.07, MG0.22±0.06. There are statistically significant differences between AMG and AG (P<0.01) and AMG and MG (P<0.01). There is no statistically significant differences between MG and AG (P>0.05).
The D-PPT in the tenth time are AMG0.10±0.05, AG0.14±0.04, MG0.17±0.03. There are statistically significant differences between three groups (P<0.01).
4. McGill Pain Questionnaire (MPQ)
The Scores of MPQ, after five times treating, is AMG9.0±2.4, AG9.4±2.3, MG10.1±2.3). There is statistically significant difference between AMG and MG (P<0.01). Score of MPQ of AMG is lower than that of MG. There are no statistically significant differences between AMG and AG (P>0.05) and between AG and MG (P>0.05).
The Scores of MPQ, after ten times treating, is AMG3.3±2.4, AG4.7±2.5, MG5.3±2.5), There are statistically significant differences between AMG and AG (P<0.05) and AMG and MG (P<0.05). Score of MPQ of AMG is the lowest. There is no statistically significant difference between AG and MG (P>0.05).
The Scores of MPQ, after one month follow-up, is AMG4.8±2.3, AG6.8±2.0, MG7.0±1.9). There are statistically significant differences between AMG and AG (P<0.01) and between AMG and MG (P<0.01). Score of MPQ of AMG is the lowest. There is no statistically significant difference between AG and MG (P>0.05).
The Scores of MPQ, after three months follow-up, are AMG7.5±2.2, AG10.2±1.8, MG9.8±1.5). There are statistically significant differences between AMG and AG (P<0.05) and between AMG and MG (P<0.05). Score of MPQ of AMG is the lowest. There is no statistically significant difference between AG and MG (P>0.05).
5. Short Form36-items Health Survey (SF-36)
There are statistically significant differences in four dimensions in SF-36in three groups (P<0.05) after ten times treating. The four dimensions are Physical Functioning (AMG87.2±7.7, AG83.8±6.3, MG82.1±4.3), Role-Physical (AMG94.1±15.8, AG87.7±17.1, MG84.0±16.8), Bodily Pain (AMG77.1±9.4, AG74.2±9.9, MG69.6±7.0) and Vitality (AMG55.6±7.1, AG52.1±7.5, MG53.5±7.2). There is statistically significant difference between AMG and MG (P<0.05) in there dimensions. There is statistically significant difference between AMG and AG (P<0.05) in Physical Functioning and Vitality. There is statistically significant difference between AG and MG (P<0.05) in Bodily Pain. There are no statistically significant differences in General Health, Social Functioning, Role-Emotional and Mental Health in three groups (P>0.05).
There are statistically significant differences in five dimensions in SF-36in three groups (P<0.05) after one month follow-up. The five dimensions are Physical Functioning (AMG83.5±7.1, AG80.1±5.1, MG79.5±4.4), Bodily Pain (AMG69.7±6.8, AG67.9±5.9, MG66.0±6.1), Vitality (AMG53.8±6.7, AG49.4±6.3, MG49.6±7.8), Role-Emotional (AMG75.8±20.5, AG68.0±13.8, MG62.4±20.4) and Mental Health (AMG49.7±8.9, AG46.1±7.4, MG45.3±7.4). There is statistically significant difference between AMG and MG (P<0.05) in five dimensions. There is no statistically significant differences in five dimensions between AG and MG (P>0.05). There is statistically significant difference between AMG and AG in Physical Functioning, Vitality, Role-Emotional and Mental Health (P<0.05). There are no statistically significant differences in Role-Physical, General Health, Social Functioning in three groups (P>0.05).
There are statistically significant differences in six dimensions in SF-36in three groups (P<0.05) after three month follow-up. The four dimensions are Physical Functioning (AMG80.7±5.3, AG77.3±4.4, MG77.7±4.0), Role-Physical (AMG59.0±13.2, AG48.9±7.2, MG54.2±13.1), Bodily Pain (AMG66.2±7.7, AG61.7±7.6, MG61.1±7.4) and Role-Emotional (AMG60.9±18.8, AG50.3±21.8, MG56.0±20.9). There is statistically significant difference between AMG and MG (P<0.05) in Physical Functioning, Role-Physical and Bodily Pain. There is statistically significant difference between AMG and AG in Physical Functioning, Role-Physical, Bodily Pain and Role-Emotional (P<0.05). There is statistically significant difference between AG and MG in Physical Functioning (P<0.05). There are no statistically significant differences in General Health and Social Functioning in three groups (P>0.05).
6. Effective Rate
A change in the Northwick Park score of5points was considered a clinically relevant change. After treatment, the clinical effective rates of three groups are91.8%,89.4%,85.4%, the chi-square test show no significant difference between any two groups (P>0.05). There months after the treatment, the clinical effective rates of three groups are89.8%,79.2%,81.3%, the chi-square test show no significant difference between any two groups (P>0.05). All there groups are effective.
Conelusion
a. Acupuncture combined with moxibustion has better therapeutic effect in instant analgesia, short term and long term than acupuncture or moxibustion in treating neck pain due to cervical spondylosis.
b. Acupuncture combined with moxibustion can both relieve pain and improve life quality of the patients of neck pain due to cervical spondylosis.
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