| 1.BACKGROUNDCervical spondylosis refers to a series of chronic symptoms caused by aging,impact of trauma,or different pathology.The main risk factors for cervical spondylosis include old age(normal aging),occupation(repeated neck movement or Prolonged inclined neck posture),neck injuries,genetic factors(family history)and smoking.Cervical Spondylosis has a high incidence in the age group between the ages of 30-65.These changes usually develop gradually,eventually leading to a widespread of morbidity.The earliest pathological change in the progression of cervical spondylosis is likely to be the organic chemistry change of the material in the intervertebral disc,which leads to decreased water content.Dehydration and shrinkage lead to changes in spinal biomechanics,resulting in loss of cushioning function of the cartilage disc.As a result,two major changes occur in different tissues(joints and ligaments),which damage tissues near the vertebral joint.As with fracture self-healing,the body heals itself in a similar way,that is,by making bone bridging sediments of marginal bone fat(or bone spurs)to cope with the current abnormal state of chronic change.In long term,the vertebrae will eventually fuse automatically.Some patients with cervical spondylosis can see that the vertebrae are automatically fused,while in most patients receiving medical care,the intervertebral disc maintains water content and activity,therefore the progression of the disease stops before automatic fusion occurs.In a few cases,chronic diseases complicated with acute intervertebral disc rupture,worsens the condition.Cervical spondylosis radiculopathy(CSR)is a series of neurological symptoms such as nerve root pain,sensory defects and motor defects caused by compressed nerve roots in the spinal neck region by intervertebral disc herniation,vertebral joint toughness,instability,trauma or tumor.The patient feels pain,numbness,tingling in the upper limb,radiation pain,or a sense of weakness.There is a clinical overlap between CSR and peripheral nerve compression syndrome.Early CSR is often accompanied with fibrous cartilage discs that is not able to maintain the axial load of the cervical spine,as a result of degenerative changes in the intervertebral disc including the high contraction and dryness of the fibrous cartilage disc.Degenerative changes in the cervical spine are often found in asymptomatic adults,meaning that most patients with CSR have no symptoms.The main causes of vertebral canal and intervertebral foramen stenosis are:disc degeneration and bulging,ligament hypertrophy,bone spurs formation,intervertebral disc height reduction,vertebral semi-dislocation and small joint lesions.Spinal stenosis can destroy sensory motor neurons and cause reflex defects.Then,intervertebral foramen stenosis causes the cervical nerve root contraction,which causes CSR.This indicates that cervical spondylosis is usually associated with intervertebral disc herniation.Clinical examinations,imaging methods and electrophysiological examination play an important role in the diagnosis and localization of CSR.Most patients diagnosed with CSR(75-90%)can be improved by non-surgical treatment,including physical therapy,cervical neck collar support,drugs(such as analgesics,muscle relaxants,Nonsteroidal anti-inflammatory drugs(NSAID)or anti-epileptic seizures),natural remedy(for example,some literature mentioned that bath salts,garlic,ginger,sesame seeds can help alleviate symptoms in patients).Other few patients using conservative methods alone did not achieve the expected result.Nonetheless,patients with significantly acute severe neurological impairment usually require emergency surgery.Traditional Chinese Medicine(TCM)is an excellent oriental traditional therapy with a long history and constant innovation.Acupuncture,as the main component of TCM,conceptualized the energy flow around the body as "Qi" and the channels of "Qi" called "Meridians".Meridians can regulate the balance of the body,maintain human health.As a result,the destruction and imbalance of energy flow "Qi" leads to pain and disease in patients.Western medicine usually uses an accurate description of the disease to define va rious health problems,and from the point of view of TCM,the imbalance of "Qi" may lead to health problems.The condition of "Qi" is judged by the patient’s symptoms,signs,complexion,behavior,tongue image(such as tongue shape,tongue color,texture and tongue coat)and radial pulse(including the frequency,rhythm,depth,strength and shape of pulse).The mechanism of acupuncture affecting local and distal physiological and pathological states is related to the contraction of subcutaneous connective tissue after mechanical stimulation.According to TCM differentiation,some acupoints can be used for the treatment of cervical spondylosis.The acupuncture and moxibustion treatment of CSR contains 76 acupoints according to literature.Acupuncture treatment of CSR is mainly concentrated in the foot SHAOYANG gall-bladder meridian,hand YANGMING lung meridian and hand TAIYANG small intestine meridian.Cervical spondylosis is a "Bi Syndrome" according to TCM,which includes shoulder pain,neck pain,neck spasms,muscle and tendon inflammation,sometimes accompanied by dizziness due to liver and kidney deficiency.The TCM pathogenesis of cervical spondylosis is caused by external wind,cold and dampness,resulting in "Qi" and blood stasis.TCM treatment of CSR mainly includes massage,acupuncture and moxibustion.Both TCM and Western medicine are able to use different methods to relieve pain and rehabilitate patients.In addition to technical treatment,they all advise patients to maintain a good lifestyle to help patients recover quickly.This study is inspired by the combination of both Chinese and Western medicine theory.Recent studies have shown that acupuncture is widely used and is effective in treating CSR.According to western medicine,patients with CSR all have anatomical structure of one or more cervical nerve involvement,which is coincided with TCM meridian theory in some degree.Therefore,we combined western medicine with TCM theory and invented a new method of points selection for treating CSR.But we still need to know whether the new method have the same effect as TCM therapy.2.OBJECTIVEThe aim of this study is to see whether there is a diffe rence in the efficacy for CSR between the new method of points selection and the traditional acupoint selection method.In order to provide research evidence for treating CSR by acupuncture guided with the knowledge of integrated Chinese and Western medicine,the new method is based on the combination of Western nerve pathway diagnosis and meridian differentiation acupoint selection method.Currently,imaging examination has important reference significance in clinical CSR diagnosis.However,acupuncture treatment of CSR mainly relies on empirical acupoint selection method.When comparing the positioning diagnosis of western medicine with TCM meridian differentiation in CSR,we found that the skin area of cervical nerve root was surprisingly consistent with the area of meridians in TCM.Therefore,whether it can combine TCM and western medicine to guide clinical practice has become the focus of this research.3.METHODSThis study was a multicenter,single-blind,randomized,controlled clinical trial.In order to ensure the sample size of 30 patients in each group and to consider the possibility of losing follow-up,42 patients were finally included in each group.Inclusion criteria included all patients with diagnosed CSR who had obvious neck pain,the Visual Analogue Scale(VAS)>3 and no history of acupuncture treatment 1 months before the study.Exclusion criteria included pregnancy/lactation,a history of previous spinal or vertebral disease,a history of complex chronic diseases such as diabetes,cardio-cerebrovascular disease or tumors,and neck discomfo rt lasting less than 30 minutes.After patients completed the questionnaire and signed consent form,in order to maintain the balance of the number of patients between groups,patients were randomly divided into Control Group and Treatment Group under the blind principle.According to the relevant literature of acupuncture on CSR,the frequency of acupoints in the literature was counted.The 10 most frequently used acupoints were selected as control points.Acupoints in the Treatment Group were selected according to meridian differentiation theory combined with western medicine positioning diagnosis,including GB20(Feng Chi),BL11(Da Zhu),ST12(Que Pen),SI15(Jian Zhong Shu),SI14(Jian Wai Shu),SI13(Qu Yuan)and C5-C8 skin regions and nerve pathways as treatment points under the guidance of western medicine theory.The acupoints in the Control Group were selected according to traditional Chinese medicine.Treatment was performed 3 times a week and lasted for 4 weeks.Disposable stainless-steel needles(0.3mm 40mm)were used.We used The McGill Pain Questionnaire(MPQ)to assess the pain of patients,and Tanaka Yasuku 20-point Questionnaire to assess the comprehensive condition of patients.MPQ was consisted of PRI,VAS,PPI,and Tanaka Yasuku 20-point Questionnaire including 4 different parts such as sign,symptom ability of work and life,and function of hand.they were assessed by the second physician who were blinded for 7 times(before the first,third,fifth,seventh and ninth treatment,after the tenth treatment,and after 30 days of follow-up).the sixth time was used to evaluate the dynamic efficacy during treatment,and follow-up scores were used to evaluate the long-term efficacy.After the questionnaire was completed,the curative effect index was calculated by Nimodipine method,and its formula(nimodipine method)was:EFFICACY INDEX(%)=(PRE-TREATMENT SCORE-POST-TREATMENT SCORE)/PRE-TREATMENT SCORE*100%.The effective rate was calculated according to the number of curative effect indicators(the curative effect index≥75%).Statistical Analysis System SAS 8.1 statistical software was used to analyze data.Paired t test was used to measure the data before and after treatment.One-way analysis of va riance(ANOVA)was used to analyze the significant difference of the same variable among multiple groups.Nonparametric test was used to measure non-normal data and multi-group measurement data of uneven variance.Chi-square test was used for enumerative data.P-value less than 0.05 was considered statistically significant.4.RESULTS4.1.BASELINE OF QUESTIONNAIRE80 cases were ultimately effective(40 in each group).Control Group includes 14 males and 26 females,the mean age was 49.28±9.46 years,and the course of the disease va ried from 3 days to 20 years.Treatment Group includes 11 males and 29 females,the mean age was 47.75±10.97 years,and the course of the disease va ried from 5 days to 7 years.The statistical results showed that there were no statistically significant differences in gender,age and disease course between the two groups P<0.05 in all),which was comparable.However,patients in different hospitals had significant differences in pre-treatment,post-treatment and recovery rates.4.2.BASELINE OF IMAGINGThere were no statistically significant diffe rences in cervical curvature,intervertebral space narrowing,or disc herniation between the two groups in the 42 X-rays and 68 Computed Tomography(CT)or Magnetic Resonance Imaging(MRI)examinations collected.C5-C6 intervertebral space stenosis and C5-C6 disc herniation were found to be the most common imaging findings.4.3.EFFICACY OF ACUPUNCTURE TREATMENT OF CSRAccording to Nimodipine method,the total effective rate of VAS score in the Control Group was 97%,and that in the Treatment Group was 94%.There was no significant difference between the two groups(P>0.05).The total effective rate was 85%in the Control Group and 80%in the Treatment Group.The statistical results showed no significant difference between the two groups(P>0.05).4.4.THE DIFFERENCE OF EFFICACY BETWEEN GROUPSCompared with the MPQ scale score before treatment,the pain level,VAS and Present Pain Intensity(PPI)of the two groups were lower after treatment than before treatment(P<0.05).Compared with the Control Group,there was no significant difference in the above three scores at the following four times:before treatment,after the 5th treatment,after the 10th treatment and a follow-up one month after the treatment finished(P>0.05).Compared with the Tanaka Yasuku Questionnaire scale score before treatment,the pain level,VAS and symptom,working ability,sign,hand function of the two groups were lower after treatment than before treatment(P<0.05).Compared with the Control Group,there was no significant difference in the above three scores at the following four times:before treatment,after the 5th treatment,after the 10th treatment and a follow-up one month after the treatment finished(P>0.05)we only used 4 times of the 7 we collected.5.CONCLUSIONIn this study,single-blind trial,randomized grouping,and seven centers were used for the same period clinical study.CSR patients who met the diagnostic criteria were included,while those who did not meet the criteria were excluded.Then,informed consent was signed and acupuncture intervention was conducted.During and one month after the treatment,corresponding data were recorded and unqualified data were excluded.The data were analyzed by software.Comparing the acupoint selection methods of the two groups,i.e.theoretical guidance of traditional Chinese and Western medicine and meridian syndrome differentiation,with the most commonly used and effective acupoints obtained by frequencies-analysis,the following conclusions are drawn:1.It is feasible to guide the treatment of CSR with the combination of traditional Chinese and Western medicine theory,that is,to adopt the positioning diagnosis of Western medicine and to treat CSR with the differentiation of meridians and collaterals.2.There is no statistical difference in curative effect and scale between meridian syndrome differentiation and acupoint selection methods and commonly used clinical acupoints.The above two conclusions need to be fu rther confirmed by the "real world study" method.At the same time,more rigorous Randomized controlled trial(RCT)design,larger sample size,wider research area,longer follow-up time,and increased image evaluation can be used to fu rther confirm these two conclusions.6.ABBREVIATION... |
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