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Clinical study of thumb-tack needle therapy for cervical radiculopathy based on meridian differentiation

2020-04-21ZhaoYu赵煜YuNiantang俞年塘LaiZhongtao赖忠涛

关键词:杭州市计划科技

Zhao Yu (赵煜), Yu Nian-tang (俞年塘), Lai Zhong-tao (赖忠涛)

1 Tonglu TCM Hospital, Hangzhou 311500, China

2 Anhui University of Chinese Medicine, Hefei 230038, China

Abstract Objective: To observe the clinical efficacy and eligibility of thumb-tack needle therapy based on meridian differentiation in treating cervical radiculopathy.Methods: A total of 70 patients with cervical radiculopathy were randomized into an observation group and a control group,with 35 cases in each group. Patients in the control group received thumb-tack needle based on conventional point selection, while those in the observation group received thumb-tack needle according to meridian differentiation. The visual analog scale (VAS) and clinical symptom scores in the two groups were compared before and after treatment, and the clinical efficacy of the two treatments was observed.Results: After treatment, the VAS score in both groups dropped significantly (both P<0.01), and the VAS score in the observation group was lower than that in the control group (P<0.01). The clinical symptoms score in both groups dropped significantly (all P<0.01), and the clinical symptoms score in the observation group was lower than that in the control group(P<0.01). The total effective rate in the observation group was higher than that in the control group (P<0.05).Conclusion: Thumb-tack needle therapy based on meridian differentiation can reduce pain score, improve clinical symptoms in patients with cervical radiculopathy, and produce more significant efficacy compared with conventional thumb-tack needle therapy.

Keywords: Acupuncture Therapy; Embedding Therapy; Intradermal Needle Therapy; Cervical Spondylopathy; Neck Pain;Radiculopathy; Running Course of Meridian; Syndrome Differentiation of Meridian

Cervical radiculopathy is a common type of cervical spondylopathy, and its common symptoms include neck pain, root muscle dysfunction and abnormal tendon reflex[1], which may cause grave impact on patients’mental and physical health. The cause of cervical radiculopathy is regarded as the intervertebral disc protrusion or bone hyperplasia compressing the nerve root. Besides, traumatic arthritis, narrowed nerve canal and inflammation around cervical vertebrae all play a role in the onset of cervical radiculopathy[2].Pathologically, cervical radiculopathy is characterized as non-bacterial inflammation, soft tissue edema, and narrowed intervertebral foramen or intervertebral space[3]. Physically, cervical radiculopathy is mainly manifested as change in cervical curvature, limited movement and restricted limb function of the affected side. Until now, cervical radiculopathy still lacks unified treatment. Western medicine treatment for cervical radiculopathy is based on surgery, and facilitated by medicine, contraction and blocking therapy. Whereas surgery bears a high risk, and it may even cause paralysis in severe cases. Medications may cause liver and kidney dysfunctions or digestive tract hemorrhage or other side reactions, and thus restrict its long-term administration[4-5]. Therefore, it’s of great importance to search for a better treatment for cervical radiculopathy.Latest research showed thumb-tack needle can effectively alleviate pain in patients with cervical radiculopathy, and its mild treatment method is conductive for long-term treatment[6]. Moreover,according to the studies by Huang XY, et al[7]and Jiang YH[8], thumb-tack needle for cervical radiculopathy based on meridian differentiation produced better clinical efficacy than that based on conventional point selection. To further investigate the clinical advantages of such method, we have treated 70 cervical radiculopathy patients with thumb-tack needle based on meridian differentiation. The report is now given as follows.

1 Clinical Materials

1.1 Diagnostic criteria

It was based on the diagnostic criteria of cervical radiculopathy in the Guiding Principles for Clinical Study of New Chinese Medicines[9]: continuous neck and shoulder pain, typical nerve root compression symptoms and reduced grip force; X-ray result showed changed cervical curvature, narrowed intervertebral distance and bone hyperplasia of the uncovertebral joint; CT and MRI results showed protrusion of intervertebral disc or narrowed intervertebral canal.

1.2 Inclusion criteria

Conformed to the diagnostic criteria of cervical radiculopathy; aged between 18 and 65 years old;informed consent.

1.3 Exclusion criteria

Accompanied by bone fracture in cervical, thoracic or shoulder region; with serious organic or mental disorders; undergoing other treatment for cervical spondylosis within 1 month or participated in other clinical studies within 3 months; women during pregnancy or lactation.

1.4 Exclusion and drop-out criteria

Those with poor compliance, changed to other treatment method during study, or didn’t conform to the treatment scheme or insufficient clinical data which may influence clinical efficacy or safety evaluation;those didn’t finish the whole treatment scheme or used other treatment method during study.

1.5 Statistical methods

Used SPSS version 21.0 software for statistical analysis. Measurement data conforming to normal distribution were described as mean ± standard deviation (x ±s), with independent sample t-test for inter-group comparison, and paired t-test for intra-group comparison. Data not conforming to normal distribution were compared using non-parametric test.Comparison of ranked data was processed using rank sum test. Nonhierarchical data were described as frequency or percentage and compared by Chi-square test. A P-value less than 0.05 was considered statistically significant.

1.6 General data

All cases were recruited between July 1st, 2018 and March 30th, 2019 in Tonglu TCM Hospital. All 70 cervical radiculopathy cases conforming to the inclusion criteria were randomized into an observation group and a control group by the random number table method,with 35 cases in each group. The patients aged between 38 and 61 years in the observation group, and their disease course ranged between 1 and 19 months. The cases aged between 37 and 60 years in the observation group, and their disease course ranged between 2 and 21 months. Between-group comparisons of the gender,age, course and pathogenesis showed no statistical significance (all P>0.05), indicating the comparability(Table 1).

Table 1. Comparison of the general data between the two groups

2 Treatment Methods

2.1 Control group

Patients in the control group received thumb-tack needle based on conventional point selection method.The point selection was based on the treatment principle for cervical spondylopathy in the Science of Acupuncture and Moxibustion[10].

Acupoints: Fengchi (GB 20), Tianzhu (BL 10), cervical Jiaji (EX-B 2), Jianjing (GB 21), Houxi (SI 3), Hegu (LI 4)and Waiguan (TE 5) on the affected side.

Methods: Took a supine position with exposition of the surrounding area. After routine sterilization,pressed the thumb-tack needle on the acupoint and fixed it with a piece of stick. Took one needle for each acupoint and retained it for 2 d, at a 2-day interval between two treatments. Six treatments were considered as 1 course, and the whole scheme lasted 1 course.

2.2 Observation group

Patients in the observation group received thumbtack needle based on meridian differentiation pointselection method.

Point-selection: Pressed acupoints including Renying(ST 9), Tianzhu (BL 10), Futu (LI 18), Fengchi (GB 20),Tianchuang (SI 16) and Tianyou (TE 16) on the affected side with the thumb and index finger of the right hand.Marked the point as positive tender point if patients felt pain, muscle tension or nodule around the affected area. The affected meridian was considered as where the positive tender point was located. If it was located on Renying (ST 9) accompanied by stomach discomfort,the affected meridian was the Stomach Meridian of Foot Yangming; if located on Tianzhu (BL 10) with back pain, the meridian was the Bladder Meridian of Foot Taiyang; if located on Futu (LI 18) with numbness in the radial side of forearm, or thumb or index finger, the meridian was the Large Intestine Meridian of Hand Yangming; if located on Fengchi (GB 20) with dizziness or bitter mouth, the meridian was the Gallbladder Meridian of Foot Shaoyang; if located on Tianyou (TE 16)with numbness in the middle or ring finger, the meridian was the Triple Energizer Meridian of Hand Shaoyang.

Acupoints: On the basis of what had been selected in the control group, the positive tender points on the affected side, Luo-Connecting points of the affected meridian and its exteriorly-interiorly related meridian on the unaffected side were chosen to be stimulated for patients in the observation group. If the Bladder Meridian was affected, Tianzhu (BL 10) and Feiyang(BL 58) on the affected side were chosen together with Dazhong (KI 4) from the Kidney Meridian of the healthy side. If the Gallbladder Meridian was affected, Fengchi(GB 20) and Guangming (GB 37) on the affected side,and Ligou (LR 5) from the Liver Meridian of the healthy side were chosen. If the Triple Energizer Meridian was affected, Tianyou (TE 16) and Waiguan (TE 5) on the affected side, and Neiguan (PC 6) from the Pericardium Meridian of the healthy side were chosen. If the Small Intestine Meridian was affected, Tianchuang (SI 16) and Zhizheng (SI 7) on the affected side, and Tongli (HT 5)from the Heart Meridian of the healthy side were chosen. If the Large Intestine Meridian was affected,Futu (LI 18) and Pianli (LI 6) on the affected side, and Lieque (LU 7) from the Lung Meridian of the healthy side were chosen. If the Stomach Meridian was affected,Renying (ST 9) and Fenglong (ST 40) on the affected side,and Gongsun (SP 4) from the Spleen Meridian of the healty side were chosen.

Methods: Took a supine position with full exposure of the acupoint. After routine sterilization, applied thumb-tack needle to the acupoint and fixed it with a paste. Took one needle for each acupoint and retained it for 2 d, at a 2-day interval between two treatments.Six treatments were considered as 1 course, and the whole scheme lasted 1 course.

3 Therapeutic Efficacy Evaluation

3.1 Observation items

The visual analog scale (VAS) and clinical symptoms scores were measured before and after treatment for both groups.

3.1.1 VAS

A ruler with a length of 10 cm was used to measure the pain severity, 0 indicating no pain, and 10 indicating unbearable pain. Patients were told to select a number to represent their pain intensity, and a higher score indicated a higher pain intensity.3.1.2 Clinical symptoms score

This was based on the Guiding Principles for Clinical Study of New Chinese Medicines[9], including neck and shoulder pain; wandering numbness and pain in the upper limb of the affected side; reduced grip force of the affected side; aversion to cold in the axillary region;positive Spurling’s test; positive Eaton test. For the items above, a score of 3 indicated severe, 2 indicated moderate and 1 indicated mild, and 0 indicated no symptom. The sum of all items was the clinical symptoms score, and the total score ranged from 0 to 18, and a higher score indicated a worse case.Therapeutic efficacy evaluation was calculated by the improvement rate of symptoms including pain and numbness. The improvement rate of symptoms including pain and numbness = (Score before treatment - Score after treatment) ÷ Score before treatment × 100%. See Table 2.

3.2 Therapeutic efficacy evaluation criteria

It was based on the Guiding Principles for Clinical Study of New Chinese Medicines[9].

Cured: Improvement rate of symptoms including pain and numbness ≥95%.

Marked effect: Improvement rate of symptoms including pain and numbness ≥70%, but <95%.

Effective: Improvement rate of symptoms including pain and numbness ≥30%, but <70%.

Invalid: Improvement rate of symptoms including pain and numbness <30%.

3.3 Results

3.3.1 Comparison of clinical efficacy

The total effective rate in the observation group was 97.1%, versus 82.9% in the control group, indicating that both methods had satisfactory therapeutic efficacy for cervical radiculopathy. After treatment, by nonparameter test, between-group comparison of total effective rate showed statistical significance (P<0.05),indicating that the treatment efficacy of thumb-tack needle therapy based on meridian differentiation was superior to that of the same therapy based on conventional point selection. See Table 3.

Table 2. Clinical symptoms evaluation items

Table 3. Comparison of clinical efficacy between the two groups (case)

3.3.2 Comparison of VAS score

The VAS scores of the two groups were compared both before and after treatment. By paired sample t-test, VAS score in both groups dropped significantly by the end of the treatment (both P<0.01), indicating that both methods can obviously improve patients’ pain.Before treatment, between-group comparison of the VAS score showed no statistical significance (P>0.05) by independent sample t-test. After treatment, betweengroup comparison of VAS score showed statistical significance (P<0.01) by independent sample t-test,indicating that thumb-tack needle based on meridian differentiation was superior to that based on conventional point selection in alleviating pain. See Table 4.

Table 4 Comparison of VAS score between the two groups( x±s, point)

3.3.3 Comparison of the clinical symptoms score

The clinical symptoms scores of the two groups were compared both before and after treatment. By paired sample t-test, clinical symptoms scores in both groups dropped significantly by the end of the treatment (all P<0.01), indicating that both methods can obviously improve patients’ clinical symptoms. Before treatment,between-group comparison of the clinical symptoms score showed no statistical significance (P>0.05) by independent sample t-test. After treatment, betweengroup comparison of the clinical symptoms score showed statistical significance (P<0.01) by independent sample t-test, indicating that thumb-tack needle therapy based on meridian differentiation was superior to that based on conventional point selection in improving clinical symptoms. See Table 5.

Table 5 Comparison of the clinical symptoms score (x ±s,point)

4 Discussion

Cervical spondylopathy pertains to Bi-impediment syndrome in traditional Chinese medicine (TCM), and causative factors include wind, cold and dampness invasion, disharmony between Ying-nutrient and Wei-defensive qi, obstruction of meridian qi, which lead to improper nourishment of limbs, and subsequently,pain and numbness around the shoulder and neck.Therefore, treatment of cervical radiculopathy should be focused on unblocking meridians and dispersing stasis. Acupuncture can regulate qi and blood and unblock meridians[11]. Therefore, for pain generated by the stagnation of qi and blood, acupuncture can eliminate pain by unblocking. Thus, we applied acupuncture theory in the treatment of cervical radiculopathy. We used Fengchi (GB 20), Tianzhu (BL 10)and Jianjing (GB 21) as local points to disperse stagnation according to the proximal treatment function of acupoints. And we used Waiguan (TE 5),Hegu (LI 4) and Houxi (SI 3) as the distal points to dredge meridian and cease pain by the distant treatment function of acupoints. For patients in the observation group, we also used positive tender points,the Luo-Connecting points of the affected meridian and its exteriorly-interiorly related meridian on the unaffected side in the spirit of meridian differentiation,to observe the clinical advantages of thumb-tack needle therapy based on meridian differentiation for the treatment of cervical radiculopathy.

To investigate the advantages of thumb-tack needle based on meridian differentiation for cervical radiculopathy, we included 70 cases in the randomized controlled trial. Results showed that compared with thumb-tack needle therapy based on conventional point selection, thumb-tack needle therapy based on meridian differentiation had a better effect in alleviating pain and improving clinical symptoms in cervical radiculopathy patients, together with a higher total effective rate. Therefore, thumb-tack needle based on meridian differentiation had more significant efficacy for cervical radiculopathy patients than that based on conventional point selection.

Thumb-tack needle therapy is an important branch of acupuncture therapy, and can be categorized into intradermal needle. Records about puncturing skin to treat Bi-impediment syndrome can be dated back to ancient times. As it’s recorded in Ling Shu (Spiritual Pivot): intradermal puncturing is used to treat superficial Bi-impediment syndrome. Thumb-tack needling is a branch of the retaining needle technique recorded in Nei Jing (Classic of Internal Medicine), which is characterized by a long duration of slight stimulation to skin around certain acupoints. By doing so, acupoint can be stimulated for a long time to guarantee a satisfactory middle-long term therapeutic efficacy of acupuncture[12]. Meanwhile, thumb-tack needle therapy is also convenient and safe, together with its pain-free manipulation. Such treatment only reaches skin without interfering deeper layer, which won’t cause harm to internal organs, vessels or nerves[13].Thumb-tack needle has a specific treatment value in treating Bi-impediment syndrome, especially in the field of middle-long term analgesia[14]. Clinical investigation reported that acupuncture based on meridian differentiation can improve the clinical efficacy[15]. Zhou YN, et al[16]found the effective rate of acupuncture based on meridian differentiation was as high as 93.3%.Therefore, we chose thumb-tack needle based on meridian differentiation to treat cervical radiculopathy patients. We hold that puncturing thumb-tack needle into relevant acupoints with a retention of 2-3 d can achieve a sustainable stimulation to certain acupoints,which was conductive to promoting excitement of acupoint and had a positive value for dredging meridians and regulating qi and blood flow[17-18]. In the view of modern science, retaining thumb-tack needle beneath skin can stimulate the micro-electronic wave and change the topical potential. At the same time,organ can release microelement and further function on the related nerves and tissues to cease pain[19].Moreover, compared with conventional filiform needle,thumb-tack needle is small in size with a shallow puncturing depth, so that, it can be easily accepted by patients. Besides, it is also effective for a series of chronic and acute diseases[20-21]. Therefore, thumb-tack needle has gained its clinical popularization in treating pain-related or chronic diseases, and always worked as a facilitation method to promote rehabilitation[22-24].

Above all, thumb-tack needle based on meridian differentiation had a satisfactory clinical effect in improving symptoms and increasing effective rate in treating cervical radiculopathy patients. Besides, its mild stimulation can be easily accepted by patients. This method can guarantee safety and effectiveness at the same time, and thus is worth clinical popularization.

Conflict of Interest

The authors declare that there is no potential conflict of interest in this article.

Acknowledgments

This work was supported by 2018 Science and Technology Development Project of Hangzhou (2018 年杭州市科技发展计划项目, No. 20181228Y172).

Statement of Informed Consent

Informed consent was obtained from the patients in this study.

Received: 14 August 2019/Accepted: 24 September 2019

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