摘要
目的：
本研究以软组织张力结合病人报告结局指标观察针刺从心胆论治颈型颈椎病的临床疗效与安全性。
方法：
本研究于2012年1月-2013年1月,在广东省中医院门诊及临床招募符合纳入标准的颈型颈椎病患者76例,采用临床随机对照试验设计,分为治疗组与对照组两个组,每组38例。
治疗组采用心胆论治针刺联合埋皮内针方案,治疗措施是先针刺后埋皮内针,针刺穴位为内关、阳陵泉、颈夹脊穴,内关与阳陵泉左右交替选用；埋皮内针穴位为心俞、胆俞,心俞与胆俞左右交替选用。针刺时患者取正坐位,采用一次性管针进行针刺,按针刺常规操作,针刺深度依据穴位部位、患者体型胖瘦定为10-20mm,每个穴位均行小幅度捻转提插手法,以得气为度,得气后留针25min,留针期间不行针。出针后让患者休息5分钟,无不适后给予埋皮内针。
对照组采用针刺联合埋皮内针方案,治疗措施是先针刺后埋皮内针,针刺穴位为中渚(双)、颈夹脊穴；埋皮内针穴位为百劳(双)。针刺时患者取正坐位,采用一次性毫针进行针刺,按针刺常规操作,针刺深度依据穴位部位、患者体型胖瘦定为10-20mm,每个穴位均行小幅度捻转提插手法,以得气为度,得气后留针25min,留针期间不行针,出针后让患者休息5分钟,无不适后给予埋皮内针。
两组均隔日治疗1次,前两周每周治疗3次,后两周每周治疗2次,10次治疗为1疗程,4周内完成。1疗程结束后观察疗效。
评价指标：以软组织张力作为客观评价指标,其包括两个指标：①施加0.5kg载荷时,局部软组织的位移大小,记为D0.5kg，单位为mm；②局部软组织所吸收能量占所做功的百分比,记为S。以NPQ颈痛量表、McGill简式疼痛量表及SF-36生存质量量表作为病人报告结局指标。
评价时点：治疗前、治疗第5次、疗程结束时、随访1个月及随访3个月时。
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PASW Statistics18.0统计分析软件进行分析,分析方法包括描述性分析、卡方检验、重复测量方差分析等。
结果：
1一般资料
两组患者在性别构成、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)；两组患者的年龄、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)。两组患者压痛点压痛程度与压痛点分布比较方面无统计学意义(P>0.05)。两组患者证候均以风寒湿型和气滞血瘀型为主。
2软组织张力
2.1D0.5kg
2.1.1治疗前两组比较
治疗前两组D0.5kg分别为：治疗组7.34±0.32mmm,对照组7.42±0.40mmm,两组比较差异无统计学意义(P>0.05)
2.1.2两组组内比较
治疗组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点D.5kg测量值分别为：7.34±0.32mmm、7.80±0.40mmm、8.18±0.51mmm、8.37±0.52mmm、8.38±0.48mmm,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
对照组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点D0.5kg测量值分别为：7.42±0.40mmm、7.91±0.50mmm、8.29±0.64mmm、8.09±0.58mmm、7.98±0.60mmm,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
2.1.3两组组间比较
第5次治疗后两组D0.5kg值分别为：治疗组7.80±0.40mm,对照组7.91±0.50mm,两组比较差异无统计学意义(P>0.05)
疗程结束后两组D0.5kg值分别为：治疗组8.18±0.51mm,对照组8.29±0.64mm,两组比较差异无统计学意义(P>0.05)
随访第1个月两组D0.5kg值分别为：治疗组8.37±0.52mm,对照组8.09±0.58mm,两组比较差异有统计学意义(P<0.05)
随访第3个月两组D0.5kg值分别为：治疗组8.38±0.48mm,对照组7.98±0.60mm,两组比较差异有统计学意义(P<0.01)
2.2S
2.2.1治疗前两组比较
治疗前两组S分别为：治疗组(58.32±5.49)%,对照组(57.41±7.63)%,两组比较差异无统计学意义(P>0.05)。
2.2.2两组组内比较
治疗组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点S测量值分别为：(58.32±5.49)%、(64.61±3.58)%、(69.17±4.69)%、(71.61±5.68)%、(71.34±6.92)%,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
对照组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点S测量值分别为：(57.41±7.63)%、(64.27+3.69)%、(68.89±5.14)%、(66.75±6.19)%、(65.68±6.07)%,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
2.2.3两组组间比较
第5次治疗后两组S值分别为：治疗组(64.61±3.58)%,对照组(64.27±3.69)%,两组比较差异无统计学意义(P>0.05)
疗程结束后两组S值分别为：治疗组(69.17±4.69)%,对照组(68.89±5.14)%,两组比较差异无统计学意义(P>0.05)。
随访第1个月两组S值分别为：治疗组(71.61±5.68)%,对照组(66.75±6.19)%,两组比较差异有统计学意义(P<0.01)。
随访第3个月两组S值分别为：治疗组(71.34±6.92)%,对照组(65.68±6.07)%,两组比较差异有统计学意义(P<0.01)。
3NPQ量表
3.1治疗前两组比较
治疗前NPQ量表评分分别为：治疗组41.88±7.78,对照组39.95±7.13,两组比较差异无统计学意义(P>0.05)
3.2两组组内比较
治疗组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点.NPQ量表评分分别为：41.88±7.78、30.26±5.45、14.35±6.06、13.14±6.35、13.41±6.38,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
对照组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点NPQ量表评分分别为：39.95±7.13、29.86±5.15、17.25+6.46、20.46±6.80、21.83±6.85,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
3.3两组组间比较
第5次治疗后两组NPQ评分分别为：治疗组30.26±5.45,对照组29.86±5.15,两组比较差异无统计学意义(P>0.05)
疗程结束后两组NPQ评分分别为：治疗组14.35±6.06,对照组17.25±6.46,两组比较差异无统计学意义(P>0.05)
随访第1个月两组NPQ评分分别为：治疗组13.14±6.35,对照组20.46±6.80,两组比较差异有统计学意义(P<0.01)
随访第3个月两组NPQ评分分别为：治疗组13.41±6.38,对照组21.83±6.85,两组比较差异有统计学意义(P<0.01)。
4McGill疼痛问卷(MPQ)
4.1治疗前两组比较
治疗前McGill疼痛问卷评分分别为：治疗组17.50±3.11,对照组17.17±3.06,两组比较差异无统计学意义(P>0.05)。
4.2两组组内比较
治疗组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点McGill量表评分分别为：17.50±3.11、11.59±2.53、5.59±2.75、4.58±2.63、4.42±2.62,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
对照组治疗前、第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点McGill量表评分分别为：17.17±3.06、12.03±2.37、6.28±2.80、7.30±3.72、7.64±3.68,治疗后各时点与治疗前比较差异均有统计学意义(P<0.05)。
4.3两组组间比较
第5次治疗后两组MPQ评分分别为：治疗组11.59±2.53,对照组12.03±2.37,两组比较差异无统计学意义(P>0.05)
疗程结束后两组MPQ评分分别为：治疗组5.59±2.75,对照组6.28±2.80,两组比较差异无统计学意义(P>0.05)。
随访第1个月两组MPQ评分分别为：治疗组4.58±2.63,对照组7.30±3.72,两组比较差异有统计学意义(P<0.01)
随访第3个月两组MPQ评分分别为：治疗组4.42±2.62,对照组7.64±3.68,两组比较差异有统计学意义(P<0.01)。
5SF-36生存质量量表
5.1治疗前两组比较
治疗前SF-36生存质量8维度评分分别如下：
PF维度：治疗组63.92±8.51,对照组64.17±7.51；RP维度：治疗组31.76±15.19,对照组31.25±13.86；BP维度：治疗组39.92±10.20,对照组41.56±10.31；GH维度：治疗组39.05±2.59,对照组39.03±2.73；VT维度：治疗组46.76±6.89,对照组46.81±6.88；SF维度：治疗组52.37±6.61,对照组54.03±7.78；RE维度：治疗组32.42±22.89,对照组34.24±21.81；MH维度：治疗组41.30±5.66,对照组41.00±5.00。两组治疗前SF-36生存质量8维度评分比较差异无统计学意义(P>0.05)。
5.2两组组内比较
两组患者第5次治疗后、疗程结束后、随访第1个月、随访第3个月时点SF-36量表8个维度评分均较治疗前升高,与治疗前比较差异均有统计学意义(P<0.05)。
5.3两组组间比较
第5次治疗后两组SF-36量表评分在生理机能、生理职能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康8个维度方面比较差异无统计学意义(P>0.05)。
疗程结束后两组SF-36量表评分在生理机能、生理职能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康8个维度方面比较差异无统计学意义(P>0.05)。
随访1个月时两组SF-36量表评分,生理职能维度治疗组评分：93.92±10.87,对照组评分：84.03±13.57；躯体疼痛维度治疗组评分：71.61±5.68,对照组评分：66.75±6.19；精力维度治疗组评分：70.14±4.33,对照组评分：66.94±5.25；两组在生理职能、躯体疼痛与精力维度方面比较差异有统计学意义(P<0.01)。
随访3个月时两组SF-36量表评分,生理机能维度治疗组评分：82.16±4.65,对照组评分：79.31±4.50；社会功能维度治疗组评分：75.68±7.18对照组评分：71.18±7.21；两组在生理机能与社会功能维度比较差异有统计学意义(P<0.05)。生理职能维度治疗组评分：89.86±12.44,对照组评分：75.00±10.35；躯体疼痛维度治疗组评分：71.34±6.92,对照组评分：65.68±6.07；精力维度治疗组评分：70.81±4.00,对照组评分：66.67±4.93；两组在生理职能、躯体疼痛与精力维度比较差异有统计学意义(P<0.01)。
6疗效
疗程结束时,经秩和检验,两组疗效比较差异无统计学意义(P>0.05)
随访第1个月时,经秩和检验,两组疗效比较差异有统计学意义(P<0.05)。
随访第3个月时,经秩和检验,两组疗效比较差异有统计学意义(P<0.05)
7显效率
疗程结束时,治疗组显效率为78.38%,对照组显效率为69.44%,经秩和检验,两组显效率比较差异无统计学意义(P>0.05)。
随访第1个月时,治疗组显效率为70.27%,对照组显效率为44.44%,经秩和检验,两组显效率比较差异有统计学意义(P<0.05)。
随访第3个月时,治疗组显效率为64.86%,对照组显效率为41.67%,经秩和检验,两组显效率比较差异无统计学意义(P>0.05)
8安全性
本研究共出现2例不良事件,经处理后未影响研究进程。
结论：
1.针刺从心胆论治颈型颈椎病安全有效,近期疗效与对照组相当,远期疗效优于对照组。
2.软组织张力可客观的评价针刺从心胆论治颈型颈椎病的临床疗效。
3.病人报告结局指标可有效的评价针刺从心胆论治颈型颈椎病的临床疗效。
Objective
This research applied soft tissue tension combined with the patient reported outcome (PRO) to observe the short and long-term clinical efficacy and security of acupuncture treatment for Neck Type of Cervical Spondylosis(NTCS) based on the concept of heart and gall bladder from TCM aspect.
Methods
76subjects were recruited from clinical patients of the Guangdong Provincial Hospital of TCM from January2012to January2013, This research used the randomized controlled clinical trial design, dividing the subjects into the treatment group and control group with38cases for each group.
The treatment group applied the program of acupuncture based on the concept of heart and gall bladder from TCM aspect combined with burying the intradermal needles. The patients were both given acupuncture treatment first and then buried the intradermal needles later. Regular acupoints are PC6, GB34(left and right alternately used), cervical EX-B2, while intradermal needle acupoints are BL15, BL19(alternately used). Patients were sitting rightly, being used disposable tube needle to acupuncture. According to the conventional operation, the needling depth was about10-20mm, mainly based on the acupoint site, patient size. Each acupoint was underwent a slight twisting and thrusting hand-manipulation until bringing about the desired sensation and the needle retention period was25min. There was no hand-manipulation of needle during the needle retention period. The patients could have a rest for5minutes and then were buried the intradermal needles if there was no discomfort.
The control group applied the program of acupuncture combined with burying the intradermal needles. The patients were both given acupuncture treatment first and then buried the intradermal needles later. Regular acupoints are SJ3(double), cervical EX-B2. Intradermal needle acupoint is HN15(double). Patients were sitting rightly, being used disposable tube needle to acupuncture. According to the conventional operation, the needling depth was about10-20mm, mainly based on the acupoint site, patient size. Each acupoint was underwent a slight twisting and thrusting hand-manipulation until bringing about the desired sensation and the needle retention period was25min. There was no hand-manipulation of needle during the needle retention period. The patients could have a rest for5minutes and then were buried the intradermal needles if there was no discomfort.
Treatments were completed every other day,3times a week in the first two weeks,2times a week in the remaining two weeks.10treatments were a course of treatment and completed within4weeks. The efficacy was evaluated after the end of one course.
Evaluation indicators:Soft tissue tension was used as the objective evaluation, including two indicators:①when0.5kg was loaded, the displacement of the soft tissue was recorded as D0.5kg with mm as unit;②the percentage of the energy of local soft tissue absorbing comparing with the work done was recorded as S. NPQ neck pain scale and McGill simple pain scale and SF-36life quality scale were used as the patient reported outcomes.
Time points of evaluation:before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months
Data management and statistical analysis:the data would be collected to establish a database by applying Epidata and using PASW Statistics18.0statistical analysis software to analyze. The analytical methods included descriptive analysis, chi-square test, repeated measures analysis of variance.
Results
1.Baseline data
By comparing the constitution of sex, the habits of lowering their head for long, the distribution of the patient's level of education, as well as experience whether they have received acupuncture treatment before of two groups'patients, no significant statistical difference (P>0.05)was found; The patients'age, the course of the disease and the average time of daily lowering head for work also had no significant statistical difference (P>0.05). By comparing the pain degree of pressure pain points and the distribution of pressure pain points of two groups' patients, no significant statistical difference difference was found (P>0.05). Patients's syndromes were mainly wind cold type and blood stasis type.
2. Soft tissue tension
Z.1D0.5kg
2.1.1Comparison between two groups before treatment
DO.5kg value before treatment:treatment group was7.34±0.32mm, control group was7.42±0.40mm. The difference between two groups was not statistically significance (P>0.05).
2.1.2Comparison within each group
D0.5kg value of treatment group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were7.34±0.32mm、7.80±0.40mm、8.18±0.51mm、8.37±0.52mm、8.38±0.48mm relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
DO.5kg value of control group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were7.42±0.40mm、7.91±0.50mm、8.29±0.64mm、8.09·0.58mm、7.98±0.60mm relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment
2.1.3Comparison between two groups
DO.5kg value after the5th treatment:treatment group was7.80±0.40mm, the control group7.91±0.50mm. The difference between two groups was not statistically significance (P>0.05).
D0.5kg value after the end of treatment:the treatment group was8.18± 0.51mm, the control group8.29±0.64mm. The difference between two groups was not statistically significance (P>0.05).
DO.5kg value in the one month follow-up:treatment group was8.37±0.52mm, the control group8.09±0.58mm. The difference between two groups was statistically significance (P<0.05).
DO.5kg value in the three months follow-up:the treatment group was8.38±0.48mm, the control group7.98±0.60mm. The difference between two groups was statistically significance (P<0.01).
2.2S
2.2. IComparison between two groups before treatment
S value before treatment:treatment group was (58.32±5.49)%, control group was (57.41±7.63)%. The difference between two groups was not statistically significance (P>0.05).
2.2.2Comparison within each group
S value of treatment group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were (58.32±5.49)%、(64.61±3.58)%、(69.17±4.69)%、(71.61±5.68)%、(71.34±6.92)%relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
S value of control group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were (57.41±7.63)%、(64.27±3.69)%、(68.89±5.14)%、(66.75±6.19)%、(65.68±6.07)%relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
2.2.3Comparison between two groups
S value after the5th treatment:treatment group was (64.61±3.58)%, control group (64.27±3.69)%. The difference between two groups was not statistically significance (P>0.05)
S value after the end of treatment:treatment group was (69.17±4.69)%control group (68.89±5.14)%. The difference between two groups was not statistically significance (P>0.05).
S value in the one month follow-up:treatment group (71.61±5.68)%, and the control group (66.75±6.19)%. The difference between two groups was statistically significance (P<0.01).
S value in the three months follow-up:the treatment group (71.34±6.92)%, and the control group (65.68±6.07)%. The difference between two groups was statistically significance (P<0.01).
3. NPQ neck pain scale
3.1Comparison between two groups before treatment
NPQ score before treatment:treatment group was41.88+7.78, control group was29.86+5.15. The difference between two groups was not statistically significance (P>0.05).
3.2Comparison within each group
NPQ score of treatment group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were41.88±7.78、30.26±5.45、14.35±6.06、13.14±6.35、13.41±6.38relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
NPQ score of control group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months.were39.95±7.13、29.86±5.15、17.25±6.46、20.46±6.80、21.83±6.85relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment
3.3Comparison between two groups
NPQ score after the5th treatment:the treatment group was30.26±5.45, control group29.86±5.15. The difference between two groups was not statistically significance (P>0.05).
NPQ score after the end of treatment:the treatment group was14.35±6.06, control group17.25±6.46. The difference between two groups was not statistically significance (P>0.05).
NPQ score in the one month follow-up:the treatment group was13.14±6.35, control group20.46±6.80. The difference between two groups was statistically significance(P<0.01).
NPQ scores in the three months follow-up:the treatment group was13.41±6.38, control group21.83+6.85. The difference between two groups was statistically significance (P<0.01).
4McGill Pain Questionnaire (MPQ)
4.1Comparison between two groups before treatment
MPQ score before treatment:treatment group was17.50+3.11, control group was17.17±3.06. The difference between two groups was not statistically significance (P>0.05).
4.2Comparison within each group
MPQ score of treatment group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months were17.50±3.11、11.59±2.53、5.59±2.75、4.58±2.63、4.42±2.62relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
MPQ score of control group before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months. were17.17±3.06、12.03±2.37、6.28±2.80、7.30±3.72、7.64±3.68relatively. The difference between two groups was statistically significance (P<0.05) after and before treatment.
4.3Comparison between two groups
MPQ score after the5th treatment:the treatment group was11.59±2.53, control group12.03±2.37. The difference between two groups was not statistically significance (P>0.05).
MPQ score after the end of treatment::the treatment group was5.59±2.75, control group6.28±2.80. The difference between two groups was not statistically significance (P>0.05).
MPQ score in the one month follow-up:the treatment group was4.58±2.63, control group7.30±3.72. The difference between two groups was statistically significance (P<0.01).
MPQ scores in the three months follow-up:the treatment group was4.42+2.62, control group7.64±3.68. The difference between two groups was statistically significance (P<0.01).
5SF-36life quality scale
5.1Comparison between two groups before treatment
Scores of eight dimensions of SF-36scale before treatment:PF dimension of treatment group was63.92±8.51, control group was64.17±7.51. RP dimension of treatment group was39.05±2.59, control group was31.25±13.86. BP dimension of treatment group was39.92±10.20, control group was41.56±10.31. GH dimension of treatment group was39.05±2.59, control group was39.03±2.73. VT dimension of treatment group was46.76±6.89, control group was46.81±6.88. SF dimension of treatment group was52.37±6.61, control group was54.03±7.78. RE dimension of treatment group was32.42±22.89, control group was34.24±21.81. MH dimension of treatment group was41.30±5.66, control group was41.00±5.00. The difference of scores of eight dimensions of SF-36scale between two groups was not statistically significance (P>0.05).
5.2Comparison within each group
Scores of eight dimensions of SF-36scale for twp groups before treatment, after the5th of treatment, the end of treatment, follow-up of one month and follow-up of3months were higher than the scores before treatment. The difference was statistically significance (P<0.05) comparing with the scores before treatment.
5.3Comparison between two groups
By comparing the eight dimension aspect of SF-36score after the5th treatment, including physiological function, physical function, bodily pain, general health, energy, social function, role emotional, mental health, the difference between two groups was not statistically significance (P>0.05).
By comparing the eight dimension aspect of SF-36score after the end of treatment, including physiological function, physical function, bodily pain, general health, energy, social function, role emotional, mental health, the difference between two groups was not statistically significance (P>0.05).
SF-36scale scores in the one month follow-up:physical function dimension score of treatment group:93.92±10.87, control group score:84.03±13.57; bodily pain energy dimension score of treatment group:71.61±5.68, control group score:66.75±6.19; dimension score of treatment group:70.14±4.33, control group score:66.94±5.25. The difference among physiological function bodily pain and energy dimension was statistically significance (P <0.01)
SF-36scale scores in the three months follow-up:physiological function dimension score of treatment group:82.16±4.65, control group score:79.31±4.50; social function dimension score of treatment group:75.68±7.18, control group score:71.18±7.21. The difference between physiological function and social function dimensions was statistically significance (P <0.05). Physiological functions dimension score of treatment group89.86±12.44, control group score:75.00±10.35; bodily pain dimension score of treatment group:71.34±6.92, control group score:65.68±6.07; energy dimension score of treatment group:70.81±4.00, control group score:66.67±4.93. The difference among physiological function, bodily pain and energy dimension was statistically significance (P<0.01).
6Efficacy
After the end of treatment, by rank sum test, the difference of the efficacy between two groups was not statistically significance (P>0.05).
In the one month follow-up, by rank sum test, the difference of the efficacy between two groups was statistically significance (P<0.05).
In the three month follow-up, by rank sum test, the difference of the efficacy between two groups was statistically significance (P<0.05).
7The significant effective rate
After the end of treatment, the significant effective rate of treatment group was78.38%, while the significant effective rate of control group was69.44%. The difference of significant effective rate between two groups was not statistically significance (P>0.05).
In the one month follow-up, the significant effective rate of treatment group was70.27%, while the significant effective rate of control group was44.44%. By rank sum test of the two independent samples, the difference of significant1effective rate between two groups was statistically significance (P<0.05).
In the three month follow-up, the significant effective rate of treatment group was64.86%, while the total effective rate of control group was41.67%. The difference of significant effective rate between two groups was not statistically significance (P>0.05).
8security
In this research, there were two cases of adverse events, but they did not affect the research process after processing,
Conclusions
1. Acupuncture based on the concept of heart and gall bladder from TCM aspect for NTCS is safe and effective. The short-term efficacy is equal to the conventional acupuncture, but the long-term efficacy is superior to conventional acupuncture.
2. Soft tissue tension can be the objective evaluation for clinical efficacy of acupuncture based on the concept of heart and gall bladder from TCM aspect for NTCS.
3. The patient reported outcomes can be the effective evaluation for clinical efficacy of acupuncture based on the concept of heart and gall bladder from TCM aspect for NTCS.
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