Acupuncture of different stimulation for the treatment of neck type cervical spondylosis:a randomised controlled trial

Da Li,Chun-Yan Chen,Wei Zhang,Jia-Yu Huang,Ren-Hong Wan＊

1Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China.2Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China.

Abstract Objective:To observe the difference in clinical efficacy of acupuncture with strong and weak stimulation in treating neck type cervical spondylosis.Methods:64 patients with neck type cervical spondylosis were randomly divided into strong stimulation group and weak stimulation group,with 32 cases in each group.The acupoints selected are Jingjiaji 5–7(cervical acupoints EX-B2 C5–C7),Tianzhu(BL10)on both sides,Houxi(SI3)on both sides,Hegu(LI4)on both sides,Geshu(BL17)on both sides,and Ashi.In the strong stimulation group,deep needling with 0.25 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method.The twisting angle was 90°–180°,the frequency was 60–90 times/min,and the needles were applied for 1 min at each point.Keep the needle for 30 minutes,twisting was performed every 10 min during the retention period.Change hands once.In the weak stimulation group,shallow acupuncture with a 0.18 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method,with a twisting angle of 60°–90°,a frequency of 30–60 times/min,and acupuncture for 10 seconds at each acupoint.Keep the needle for 30 minutes,and no needle during the retention period.Patients in both groups were treated once every 1 to 2 days,3 times a week for 2 weeks,and followed up for 1 month after all treatments.The two groups of patients were compared before and after treatment and during follow-up.The McGill pain questionnaire score and the cervical spine dysfunction index score were compared to determine the clinical efficacy.Statistical analysis was performed using SPSS 22.0 statistical software.Results:1 case drop-out in the strong stimulation group and 1 case in the weak stimulation group.The total effective rate of the strong stimulation group was 90.32%,the total effective rate of the weak stimulation group was 83.87%,and the total effective rate of the strong stimulation group was higher than that of the weak stimulation group(P<0.05).The total scores of the short-form McGill pain questionnaire,the VAS score,and the cervical spine dysfunction index scores of the two groups of patients were significantly lower than those of this group before treatment,and the difference was statistically significant(P<0.05).The total scores of the short-form McGill pain questionnaire,visual analogue scale score,and cervical spine dysfunction index scores of the strong stimulation group after treatment and follow-up were significantly lower than those of the weak stimulation group(P<0.05).Conclusion:Acupuncture with strong and weak stimulation can effectively treat patients with cervical spondylosis,and deep acupuncture with filiform needles and strong stimulation have better effect.

Keywords:Acupuncture,Irritation,Neck type cervical spondylosis,Randomised controlled trial

Background

Cervical spondylosis is a series of clinical syndromes caused by degenerative changes of cervical disc tissue that stimulate the spinal cord,nerve root,sympathetic nerve or vertebral artery[1].According to the different tissues and structures involved,cervical spondylosis is divided into six types.Among them,neck type cervical spondylosis is one of the most common types in clinical practice,and the incidence tends to increase year by year.As the early stage of other types of cervical spondylosis[2],neck type cervical spondylosis is a key period for treatment,early active intervention plays a crucial role in the prevention and treatment of cervical spondylosis.In the treatment of this disease,acupuncture has the advantages of accurate curative effect,simple and cheap,few side effects and safety,has been widely adopted,and has become one of the most commonly used methods in the treatment of neck type cervical spondylosis in traditional Chinese medicine[3,4].In clinical practice,the author found that the curative effects of acupuncture on neck type cervical spondylosis were significantly different with different amounts of acupuncture stimulation.Therefore,this study took patients with neck type cervical spondylosis as the research object to study the influence of strong and weak stimulus on the efficacy of acupuncture,so as to provide some clinical evidence for the optimization of the acupuncture treatment plan for this disease.

Clinical data

Diagnostic criteria

The diagnostic criteria of western medicine refer to the diagnostic criteria of neck type cervical spondylosis in the“Expert Consensus on Classification,Diagnosis and Non-surgical Treatment of Cervical Spondylopathy”[5]published in theChinese Journal of Surgeryin 2018.(1)The patient complains of abnormal sensations such as occipital,neck,and shoulder pain,which may be accompanied by corresponding tenderness points.(2)The results of imaging examination showed degenerative changes of the cervical spine.(3)Exclude other neck diseases or neck symptoms caused by other diseases.

Inclusion criteria

(1)Meet the above diagnostic criteria.(2)18 years old≤patient age≤65 years old,no gender limit.(3)The patient voluntarily signed the informed consent form.It will be included only if all the above conditions are met.

Exclusion criteria

(1)Take any analgesics within 1 week before the first acupuncture treatment and throughout the treatment period.(2)Cervical spine fractures,dislocations,tumors,tuberculosis,severe osteoporosis.(3)Patients with a history of neck trauma or surgery,or congenital cervical spine disease.(4)Patients with severe cardiovascular,cerebrovascular,diabetes,liver,kidney and blood system diseases,and mental illness.(5)Women who may have pregnancy plans and lactation during pregnancy.(6)Concomitant infectious diseases such as local skin infections that affect acupuncture operation.All patients who meet any of the above items will be excluded.

Falling off standard and rejection standard

(1)Subjects who request to withdraw from clinical trials after inclusion.(2)Patients who cannot continue treatment due to various reasons such as accidental injury or special physiological conditions(pregnancy,etc.).(3)Those who received other treatments other than this treatment during the treatment.(4)Patients who were lost to follow-up during treatment.(5)Patients whose condition deteriorates during treatment and are not suitable for the current treatment plan.(6)Patients who were mistakenly entered because they concealed their medical history and other circumstances did not meet the inclusion criteria.(7)Patients who fail to follow the prescribed treatment plan and cannot determine the clinical efficacy.

Termination test criteria

(1)During the implementation of the experiment,serious adverse events that have a causal relationship with the subject occurred.(2)During the test period,major diseases such as severe cardiovascular and cerebrovascular emergencies occurred.

Blinding

In this study,single-blind evaluation was used,and a third party who did not know the grouping situation was used to evaluate the efficacy;the data summary stage used blind statistical analysis,and implemented three separations of investigator,operator,and statistician.

Random method

In this clinical research plan,64 patients were enrolled,and Excel 2010 was used to generate random numbers,and the case allocation ratio was 1:1,and they were randomly divided into strong stimulation group and weak stimulation group.

General information

The research objects of this clinical observation are all from patients and recruited subjects of Tianjin Aiyitang Traditional Chinese Medicine Clinic.The case collection time is from January 2019 to December 2019.According to the random number table method,they were randomly divided into strong stimulation group and weak stimulation group,each with 32 cases,a total of 2 cases fell out,and each group actually included 31 patients.In the strong stimulation group,there were 14 males and 17 females;they were 19–63 years old,with an average of(31.06±12.78)years;18 cases had a course of less than 1 year,13 cases had 1 to 5 years,and 0 cases had more than 5 years.In the weak stimulation group,there were 13 males and 18 females;they were 21–57 years old,with an average of(33.23±8.57)years old;19 cases had a course of less than 1 year,12 cases had 1 to 5 years,and 0 cases had more than 5 years.There was no statistically significant difference in general information between the two groups of patients(P>0.05),and they were comparable.

Methods

Treatment methods

Point selection.The selection of acupoints is based on the textbookAcupuncture and Moxibustion[6]of the national higher school of Chinese medicine.The selection of acupoints for neck type cervical spondylosis:Jingjiaji 5–7(cervical acupoints EX-B2 C5–C7),Tianzhu(BL10)on both sides,Houxi(SI3)on both sides,Hegu(LI4)on both sides,Geshu(BL17)on both sidesand Ashi points.The acupoint positioning is based on the positioning standards in the“National Standards of the People’s Republic of China·Part of Meridians and Acupoints”.

Method of operation.Strong stimulation group:use 0.25 mm×40 mm(1.5 inches,Huatuo brand,Suzhou Medical Supplies Factory Co.,Ltd.)acupuncture needles,the patient is in a sitting position.The doctor uses an alcohol cotton ball to disinfect all acupoints first,and then the doctor’s hands are disinfected.Tianzhu(BL10),Jingjiaji 5–7(cervical acupoints EX-B2 C5–C7),Geshu(BL17)straight 0.8 cun;Houxi(SI3),Hegu(LI4),Ashi points straight 1 cun.After the acupuncture has“arrival of Qi”,the method of flattening,replenishing and reducing is performed,the twisting angle is 90°–180°,the frequency is 60–90 times/min,and each acupoint is acupuncture for 1 minute.The needle was retained for 30 minutes,and the above-mentioned method of replenishing,replenishing and reducing was performed once every 10 minutes.After the end,the dry cotton ball presses up the needle.

Weak irritation group:use 0.18 mm×40 mm(1.5 inches,Huatuo brand,Suzhou Medical Supplies Factory Co.,Ltd.)acupuncture needles,the patient adopts a sitting position.The doctor uses an alcohol cotton ball to disinfect all acupoints first,and then the doctor’s hands are disinfected.Tianzhu(BL10),Jingjiaji 5–7(cervical acupoints EX-B2 C5–C7),Geshu(BL17)straightly 0.3 inch;Houxi(SI3),Hegu(LI4),Ashi points 0.5 inch straight.After acupuncture has deqi,the method of flattening,replenishing and reducing is performed,the twist angle is 60°–90°,the frequency is 30–60 times/min,and each acupuncture point is acupuncture for 10 seconds.The needle was retained for 30 minutes,and no needle manipulation was performed during the retention period.After the end,the dry cotton ball presses up the needle.

Patients in both groups were treated once every 1 to 2 days,3 times a week for 2 weeks.Follow-up for 1 month after the end of all treatments.

Observation indicators and methods

(1)Short-form McGill pain questionnaire(SF-MPQ)scores,including:pain rating index score,visual analogue scale(VAS)score,present pain intensity score.(2)Neck disability index(NDI)scale.

Efficacy criteria

Refer to the 2002“Guiding Principles for Clinical Research of New Chinese Medicines”[7],the details are as follows.

Clinical recovery:after treatment,the symptoms and signs disappeared or basically disappeared(the curative effect index≥95%).

Significantly effective:after treatment,the symptoms and signs are significantly improved(95%>curative effect index≥70%).

Effective:after treatment,the symptoms and signs have improved(70%>the efficacy index≥30%).

Invalid:after treatment,the symptoms and signs are not significantly improved(the curative effect<30%).

The curative effect index(using nimodipine method):((integral before treatment-integral after treatment)÷integral before treatment)×100%.

Total effective rate=(number of clinically cured cases+number of markedly effective cases+number of effective cases)/total number of cases×100%

Safety evaluation

At any time,record the adverse events such as stuck needles,fainting needles,bleeding or hematoma,broken needles,infections during the acupuncture treatment,as well as major safety events and cardiovascular and cerebrovascular diseases that are causally related to the subject.

Statistical method

The data were input by Excel 2010 and analyzed by SPSS 22.0 statistical software.Description of data:counting data were tested by chi-square test.Measurement data of normal distribution were expressed as mean and standard deviation(x±s),and measurement data of skewness distribution were expressed as median and quad spacing M(P25,P75).The enumerative data are expressed as constituent ratios.Normally distributed data:analysis of variance was used for comparison between groups.Skewness distribution data:K-W test in nonparametric test was used for comparison between groups.Repeated measurement data were analyzed using Mixed Linear model,and α=0.05 was taken as the test level.P<0.05 was considered statistically significant difference between the two groups tested.

Results

During the course of treatment,1 case in the strong stimulation group dropped out,the patient required to withdraw from the trial due to faint during acupuncture treatment.One case in the weak stimulation group fell off due to personal reasons.Finally,62 patients were included in the statistical analysis,31 in each group.

Comparison of the total clinical effective rate between the two groups

14 cases in the strong stimulation group were cured,14 cases were improved,and 3 cases were not cured,with a total effective rate of 90.32%.In the weak stimulation group,7 cases were cured,19 cases were improved,and 5 cases were not cured,with a total effective rate of 83.87%.By rank sum test of frequency distribution of each efficacy interval,the efficacy of the strong stimulation group was significantly better than that of the weak stimulation group,and the difference was statistically significant(P<0.05)(Table 1).

Comparison of total SF-MPQ score,VAS score and NDI scale score between 2 groups

There was no statistically significant difference in the above indicators between the two groups of patients before treatment(P>0.05),indicating that the data of the two groups of patients are comparable.

The comparison of the total scores of the SF-MPQ between the two groups showed that there was no interaction effect at the time point of the group(P>0.05).Comparison of SF-MPQ between the two groups of patients:compared with before treatment,the changes in scores of the two groups after treatment and follow-up were statistically significant(P<0.05).Compared with the weak stimulation group,the total score of SF-MPQ in the strong stimulation group decreased significantly,and the difference was statistically significant(P<0.05).

The comparison of VAS scores between the two groups showed no interaction effect at the time point of group(P>0.05).Comparison of the VAS scores of the two groups of patients within the group:compared with before treatment,the score changes of the two groups after treatment and during follow-up were statistically significant(P<0.05).Comparison between groups:compared with the weak stimulation group,the VAS score of the strong stimulation group decreased significantly,and the difference was statistically significant(P<0.05).

The comparison of the total NDI scores between the two groups showed that there was no interaction effect at the time point of the group(P>0.05).Comparison of NDI between the two groups in the total group:compared with before treatment,the score changes of the two groups after treatment and during follow-up were statistically significant(P<0.05).Comparison between groups:compared with the weak stimulation group,the NDI total score of the strong stimulation group was significantly decreased,and the difference was statistically significant(P<0.05)(Table 2).

Table 1 Comparison of clinical efficacy between the two groups after treatment

Table 2 Changes in the scores of the two groups of patients

Safety evaluation

Among the 64 patients included in this study,1 patient in the strong stimulation group suffered from fainting during acupuncture treatment.Due to the mental tension of the patient,the patient appeared pale,palpitation and sweating,so the acupuncture was stopped immediately and all the needles were lifted.The patient was allowed to lie on his back for about 15 minutes and returned to normal.The patient asked to withdraw from the study.The other 63 patients had no adverse reactions,such as acupuncture fainting,acupuncture delay,broken needles,and acupuncture site infection.The results indicated that the two treatment methods were safe.A small number of patients have mild subcutaneous stasis after acupuncture,no obvious hematoma,patients have no discomfort.

Discussion

Neck type cervical spondylosis belongs to the categories of“Xiangbi”,“Xiangqiang”,“Jinbi”and“Bi syndrome”in Chinese medicine.Meridians and collaterals are located in the meridians,and the pathogenesis is mostly caused by the invasion of external pathogens and the bowing of the head for long periods of time.Stagnation of qi and blood stasis,impaired blood vessels leads to pain;the body fluid is blocked,the muscles and veins are not nourished,and the loss of nourishment leads to pain.Clinical manifestations mainly of neck stiffness,pain,limited mobility as the features.In the treatment,the main principles are relaxation of tendons and collaterals,activating blood and relieving pain.Therefore,this study selected local acupuncture points Jingjiaji 5–7(cervical acupoints EX-B2 C5–C7),Tianzhu(BL10)and Ashi points to clear the Qi and blood of the meridian and relieve pain in the affected area,which embodies the connotation of acupuncture“where the points are,where the main treatment is”.The Houxi(SI3)is used to relieve pain by easing the menstrual flow,which embodies the acupuncture connotation of“the meridian passes,the main treatment is reached”.The Houxi(SI3)is Shu-Stream acupoint for the Small Intestine Meridian of Hand-Taiyang,and it is also a point at the crossing acupoint of the eight meridians,which connects the governor meridian.“The Shu-Stream acupoints are mainly used to treat the diseases of heavy body and joint pain”,“if the patient of neck stiffness,severe headache,should be selected after the Houxi(SI3)”.The Hegu(LI4)is matched with Geshu(BL17)to promote qi and blood circulation to relieve pain.

Western medicine treatment of this disease is generally symptomatic and supportive treatment,which cannot fundamentally treat the disease,and there are certain side effects,which are relatively limited[8].In recent years,studies[9–13]have found that acupuncture has a long history of treatment of neck type cervical spondylosis and has a significant effect,and the amount of acupuncture stimulation is a key factor affecting the effect.Studies[14,15]have shown that needles,acupuncture techniques,arrival of Qi,the time to retain the needle and the interval between two times are the key points that affect the amount of acupuncture stimulation,and the acupuncture technique is the core.

This study started from clinical practice and adjusted the amount of acupuncture stimulation from five aspects:needle,twist angle,frequency,operation time,and acupuncture depth.The study found that after acupuncture,the VAS score,the total scores of SF-MPQ and NDI scores of the two groups were significantly lower than those before the treatment.Follow-up 1 month after the end of all treatments,the curative effect can still be maintained.The VAS score,total SF-MPQ score,and the total NDI score of the strong stimulation group were significantly lower than those of the weak stimulation group.SF-MPQ is to evaluate the nature,degree and psychological factors of the patient’s pain in detail[16].The higher the score,the more severe the pain and the worse the psychological condition.Among them,the VAS score is the most simple,easy and intuitive method of pain intensity assessment recognized at home and abroad.Its subjective and quantitative assessment method of pain is generally recognized and widely used in clinical practice.The NDI scale focuses on evaluating the impact of patients’cervical spine dysfunction on daily life and work.This study used the above scale for comprehensive evaluation,which can more accurately and objectively reflect the condition of cervical pain and cervical spine dysfunction,and make the research results more reliable.

Mixed linear model is based on Akaike information criterion value or Schwarz Bayesian information criterion to select the best model results.The smaller the Akaike information criterion value and the Bayesian information criterion value,the better the model fit.The mixed linear model effects model is a simple,easy and effective method to process longitudinal data[17].

For neck type cervical spondylosis,strong stimulation can effectively improve the circulation of qi and blood after reaching a certain degree and time,and exert a better analgesic effect.The weak stimulus has a gentler effect and produces a certain cumulative effect of acupuncture over time,so it also has a certain effect.

This study shows that acupuncture treatment of patients with neck type cervical spondylosis with strong stimulation can more effectively reduce the patient’s neck pain,improve the functional activities of the cervical spine,and has high safety,which is worthy of clinical promotion.