Clinical Research On Efficacy Of The Acupuncture Treatment For Neck Type Of Cervical Spondylosis Based On The Heart And Gall Bladder Concept And Its Effect On Soft Tissue Tension Of Neck

ObjectiveThis 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.Methods76subjects 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 of3monthsData 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 dataBy 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 tensionZ.1D0.5kg2.1.1Comparison between two groups before treatmentDO.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 groupD0.5kg 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 treatment2.1.3Comparison between two groupsDO.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).2.2S2.2. IComparison between two groups before treatmentS 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 groupS 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 groupsS 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 scale3.1Comparison between two groups before treatmentNPQ 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 groupNPQ 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 treatment3.3Comparison between two groupsNPQ 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 treatmentMPQ 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 groupMPQ 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 groupsMPQ 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 scale5.1Comparison between two groups before treatmentScores 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 groupScores 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 groupsBy 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).6EfficacyAfter 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 rateAfter 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).8securityIn this research, there were two cases of adverse events, but they did not affect the research process after processing,Conclusions1. 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.