Aligned Acupuncture at Muscle Regions plus Cutaneous Needle for Upper Limb Spasticity After Stroke: A Multicenter Randomized Controlled Trial

1 No.252 Hospital of the Chinese People's Liberation Army, Baoding 071000, China

2 Wangdu Hospital of Traditional Chinese Medicine, Hebei Province, Wangdu 072450, China

3 Baoding No.1 Hospital of Traditional Chinese Medicine, Baoding 071000, China

4 Affiliated Hospital of Hebei University, Baoding 071000, China

SPECIAL TOPIC STUDY

Aligned Acupuncture at Muscle Regions plus Cutaneous Needle for Upper Limb Spasticity After Stroke: A Multicenter Randomized Controlled Trial

Hou Li-jun1, Han Shu-kai2, Gao Wei-na2, Xu Yu-na2, Yang Xin-wei3, Yang Wei-hong4

1 No.252 Hospital of the Chinese People's Liberation Army, Baoding 071000, China

2 Wangdu Hospital of Traditional Chinese Medicine, Hebei Province, Wangdu 072450, China

3 Baoding No.1 Hospital of Traditional Chinese Medicine, Baoding 071000, China

4 Affiliated Hospital of Hebei University, Baoding 071000, China

Author: Hou Li-jun, associate chief physician

Objective: To evaluate the clinical efficacy of aligned acupuncture at the muscle regions plus cutaneous needle for post-stroke upper limb spasticity.

Methods: By adopting a design of multicenter randomized controlled clinical trial, 488 patients with post-stroke upper limb spasticity were randomized into a treatment group and a control group, 244 in each group. In addition to rehabilitation training, the treatment group received aligned acupuncture at the muscle regions plus cutaneous needle therapy and the control group received conventional Western medicine. After successive 3-week treatments, the clinical efficacy, spasticity degree of the upper limb, joint function, and neurological defect degree were evaluated in the two groups.

Results: The total effective rate was 93.4% in the treatment group versus 61.5% in the control group, and the difference was statistically significant (P＜0.05). The upper-limb spasticity degree, joint function, and neurological defect degree were improved significantly in both groups after intervention (P＜0.05), and the improvements in the treatment group were more significant than those in the control group (P＜0.05 orP＜0.01).

Conclusion: Aligned acupuncture at the muscle regions plus cutaneous needle therapy is effective in treating post-stroke upper limb spasticity.

Musculature of 12 Meridians； Cutaneous Acupuncture； Stroke；Complications； Spasm； Randomized Controlled Trial

As a commonly encountered disease, cerebrovascular accident (CVA) has high incidence, disability, and relapse rates, seriously threatening the health of people. Approximately 89% of the survivors suffer from dysfunctions of varying degrees. Spastic cerebral palsy is a pathogenic state during the recovery of stroke, commonly seen in the neurology department. An improper treatment may seriously affect the recovery of limb function, not only bringing great pain to patients, but also heavy burden to the family and society. In normal people, upper limbs usually undertake 80% of the activities, which is to say, the quality of daily life largely depends on the function of upper limbs. Therefore, it’s become the key problem to relieve upper-limb spasticity, control abnormal movement pattern, and promote coordinating movement. In recent years, based on the concept of holism of traditional Chinese medicine, and the theories of the twelve muscle and cutaneous regions, we treated post-stroke upper limb spasticity with aligned acupuncture at muscle regions plus cutaneous needle therapy. The report is now given as follows.

1 Clinical Materials

1.1 Diagnostic criteria

The diagnosis of cerebral stroke was based on theKey Diagnostic Points for Cerebrovascular Diseasesby the Fourth Chinese Cerebrovascular Diseases Conference[1], and in reference to the results of head CT scan or MRI examination. The diagnosis of upper limb spasticity was in reference to the key diagnostic points for spasticity in theClinical Guidelines for Diagnosis and Treatment: Physiotherapy and Rehabilitationby the Chinese Medical Association[2]: muscle hypertonia during the passive movement of arm, and extensor or flexor stiffness in severe spasticity； aches in topical joint and muscle, and contracture resulting from long-term spasms；increased tendon reflexes； impaired motor function and activities of daily living.

1.2 Inclusion criteria

Conforming to the above diagnostic criteria； age 47-80 years old； stable vital signs and clear consciousness； spasticity degree Ⅰ-Ⅳ (according to the modified Ashworth scale, MAS) and Ⅱ-Ⅴ stage (according to Brunnstrom stage)； disease duration within 3 months； willing to participate the study and having signed the informed consent form.

1.3 Exclusion criteria

Critical or unstable condition, accompanied by disturbance of consciousness or severe cognitive impairment； severe disease of heart, lung, liver or kidney, diabetes, or severe hemorrhagic tendency；use of sedatives or relaxants recently.

1.4 Dropout criteria

Disobeying the rules or bad compliance； severe adverse effects or events； severe complications or aggravated conditions.

1.5 Design of trial

This study adopted a design of multicenter randomized controlled clinical trial. In each of the four centers, a treatment group and a control group were developed, a minimum of 60 subjects were recruited in each group, and 480 subjects were required in total. Based on a dropout rate of 15%, the sample size was expanded to be 552. Grouping process was running simultaneously in the four centers, by generating random numbers with Visual Basic 6.0, and the ratio between the treatment group and control group was 1:1. The random protocol was concealed by an envelope. The study began when approved by the Ethics Committee and officially agreed by the subjects. In order to achieve a high quality, the study results were evaluated repeatedly by trained staff.

1.6 Statistical analyses

The statistical analyses were conducted by the research group. The eligible subjects who had good compliance and finished the whole required treatments as well as the case report form were included for the final data analyses. The SPSS 14.0 was used. The measurement data were expressed asThe inter-group comparisons and pre-/posttreatment comparisons in the same group were processed byt-test. Regarding the enumeration data, the categorical data were analyzed by using Chi-square test, while the ranked data were by rank sum test orRidittest.

1.7 General data

During March 2007 and March 2013, the four study centers, No.252 Hospital of the Chinese People's Liberation Army, Wangdu Hospital of Traditional Chinese Medicine, Affiliated Hospital of Hebei University, and Baoding No.1 Hospital of Traditional Chinese Medicine, had finished the observation in totally 488 subjects and established the database, 122 subjects in each center. Of the 488 subjects, 362 were inpatients while 126 were outpatients. The 488 subjects were randomized into a treatment group and a control group, 244 in each group. In the treatment group, the subjects’ age ranged 45-72 years old, and disease duration 7 d-2.1 months. In the control group, the subjects’ age ranged 47-81 years old, and disease duration 6 d-2.1 months. According to the statistical analysis, there were no significant differences in comparing the general data between the two groups (P＞0.05), indicating the comparability (Table 1).

2 Treatment Methods

The two groups both conducted rehabilitation training for spasticity, such as the appropriate limb position, maintaining of joint movement, relief of the spasms around the motor control points, static stretch of muscles, passive movements and massage.

Table 1. Comparison of general data

2.1 Treatment group

According to the exterior-interior relationship, the meridians were divided into 3 groups: the Lung Meridian of Hand Taiyin and Large Intestine Meridian of Hand Yangming, Pericardium Meridian of Hand Jueyin and Triple Energizer Meridian of Hand Shaoyang, Heart Meridian of Hand Shaoyin and Small Intestine Meridian of Hand Taiyang. A cutaneous needle was used to puncture the three yin meridians of hand first, followed by aligned acupuncture at muscle regions of the three yang meridians of hand.

2.1.1 Cutaneous needle therapy

Treated areas: The Lung Meridian, Pericardium Meridian and Heart Meridian were tapped by cutaneous needle along the meridians, especially at the Five Shu-Transmitting, Yuan-Primary, Luo-Connecting, Xi-Cleft points, and the affected joints. The interior edge of the scapular was also treated for internal rotation of upper limb.

Operation: Hold the plum-blossom needle in the right hand, and pinch the needle handle with the thumb and middle finger while place the index finger at the top of the middle of the handle and fix the tail of the handle at the hypothenar with the ring finger and little finger. After routine sterilization with 75% alcohol, perpendicularly tap the topical area with moderate force (majorly use the wrist force and make the topical skin reddish but without bleeding). Every time, two meridians were chosen to treat, once every day, 7 sessions as a treatment course.

2.1.2 Aligned acupuncture at muscle regions

Points: Five Shu-Transmitting points of the three yang meridians of hand, Jianjing (GB 21), Jianliao (TE 14), and Jianzhen (SI 9).

Operation: The patient took a supine position. Filiform needles of 0.25 mm in diameter and 50 mm in length were used. The Jing-Well points were treated with bloodletting therapy, while the other points were punctured perpendicularly till the superficial layer of tendons. Between each two points, needles were inserted by distance of 1-2 cun, generally 5-7 needles for each meridian. After qi arrived, reinforcing manipulations were adopted, and the needles were manipulated every 10 min and retained for 30 min. The treatment was given once every day, 7 times as a treatment course.

2.2 Control group

The control group was intervened by intravascular injection with Piracetam injection 4 g (Shandong Lukang Cisen Pharmaceutical Co., Ltd., No. H20045019), Cerebroprotein Hydrolysate 20 mL, mixed into 0.9% normal saline 250 mL, once each day, 7 sessions as a treatment course.

The therapeutic efficacies of the two groups were evaluated after 3 treatment courses.

3 Evaluation of Therapeutic Efficacy

3.1 Observation indexes and methods

3.1.1 Spasticity degree of upper limb

The upper-limb spasticity was estimated by MAS[3].

3.1.2 Upper limb joint function

The improvements of the motor function of the upper-limb joints (shoulder adduction, pronation of the forearm, flexion of the elbow, flexion of the wrist, flexion of the fingers) were compared and analyzed between the two groups.

3.1.3 Neurological defect degree

TheCriteria of Neurological Defect Degree for Post-stroke Patientswere adopted for evaluation[1].

0 degree: the upper limb is unable to move； Ⅰdegree: the angle between upper limb and the bodydegree:the angle between the upper limb and bodydegree:the upper limb is able to lift up to the level of shoulder or slightly below； Ⅳdegree: the upper limb is able to lift up higher than shoulder；degree:the upper limb is able to lift normally but unable to defend against forces； Ⅵdegree: normal.

The above degrees were marked respectively 0, 1, 2, 3, 4, 5, 6 scores.

3.2 Criteria of therapeutic efficacy

By referring to the relevant literatures[4], the criteria of the therapeutic efficacy were made according to the reduction of muscle tone.

Recovery: The muscle tone was back to normal level.

Markedly effective: The muscle tone was not back to normal level, but decreased by 2 levels.

Improved: The muscle tone decreased by 1 level.

Invalid: The muscle tone was not improved after intervention.

3.3 Treatment result

3.3.1 Comparison of the MAS

After treatment, the two groups both had significant improvements in muscle tone after intervention (P＜0.05), and the improvement in the treatment group was more significant than that in the control group (P＜0.05), (Table 2).

Table 2. Comparison of MAS degree (case)

3.3.2 Comparison of the motor function of the upperlimb joints

The motor functions of the upper-limb joints in the two groups were improved significantly after interventions (P＜0.05), and the improvement rate in the treatment group was significantly higher than that in the control group (P＜0.05), indicating that the treatment group is superior to the control group in improving the motor function of the upper-limb joints (Table 3).

Table 3. Comparison of upper limb joint function (case)

3.3.3 Comparison of neurological defect

The neurological defects were ameliorated significantly in both groups after interventions (P＜0.05), and the inter-group difference in comparing the amelioration was statistically significant (P＜0.05), indicating that the two treatment protocols both can improve the neurological defect, but the treatment group is superior to the control group (Table 4).

3.3.4 Comparison of clinical efficacy

The total effective rate was 93.4% in the treatment group versus 61.5% in the control group, and the difference was statistically significant (P＜0.05), suggesting that the therapeutic efficacy of the treatment group should be better than that of the control group (Table 5).

Table 4. Comparison of neurological defect

Table 5. Comparison of clinical efficacy (case)

4 Discussion

The upper-limb spastic hemiplegia is one of the major post-stroke dysfunctions, manifested by spastic flexors and flaccid paralysis of extensors of the upper limb. The hypermyotonia and continuous spasticity will disturb the restoration of normal motor pattern. Therefore, it has become the key problem to relieve muscle spasticity, correct abnormal motor pattern, and promote the separate movements for the rehabilitation of patients. According to its clinical manifestations, the etiology is concluded to be blockage of wind-phlegm in collaterals, dysregulation of qi and blood, malnutrition of tendons, and imbalance between yin and yang. The basic characteristic is flaccidity of the yang aspect and spasticity of the yin aspect. The three yang meridians of hand belong to the Fu organs and connect with the Zang organs, while the three yin meridians of hand belong to the Zang organs and connect with the Fu organs. They are exteriorly-interiorly related with and corresponding to each other. The treatment principle is to supplement deficiency and reduce excess, and to regulate yin and yang.

We selected the Five Shu-Transmitting points as the major points, because the specific points are suggested to have biophysical and effective specificities[5]. The along-meridian points of the affected upper limb were added to increase the stimulation and promote the conduction of meridians[6-8]. The Five Shu-Transmitting points are located around joints, where the muscle regions are gathered. Traditional Chinese medicine holds that themuscle regions are the joint area of meridian qi and blood, the connecting part of the twelve meridians with the peripheral system of human body, and also a crucial part of motor system. The muscle regions run on a comparatively superficial layer, and thus tend to contract external pathogens. Phlegm, deficiency, and stagnation are three major pathogenic factors. Problems will occur when the twelve muscle regions are invaded by external pathogens, causing phlegm and stagnation, and malnutrition of tendons and vessels. Therefore, the three yang meridians of hand were selected treated with aligned acupuncture method to regulate qi and blood, supplement the yang meridians, strengthen the function of tendons of yang meridians； it can also unblock meridians and collaterals, smoothen the joints, activate the flaccid tendons and restore the function. Stroke is diseased at brain, usually caused by blockages in cerebral vessels due to various reasons. The three yang meridians of hand all run upward to head. When treated by acupuncture, they can wake up mind and open orifices, nourish muscle regions, and restore the upper-limb motor function[9-10]. Combined with aligned acupuncture at muscle regions, it can stimulate the upper limb nerves, improve the nutrition of nerves, promote the metabolism of tissues, enhance the excitability, and benefit the recovery of the diseased nerves. Meanwhile, it can also boost the topical blood circulation, and enhance the hypomyotonia by inducing muscle contraction.

The cutaneous regions are the manifested muscle regions of the twelve meridians on skin. Disease starts from the cutaneous regions, and then invades internal organs through meridians and collaterals； at the same time, the diseases of internal organs can also manifest on the cutaneous regions. It’s found that there are node-like products along the three yin meridians of hand in patients with post-stroke upper limb spasticity. Therefore, cutaneous needle was adopted to stimulate the cutaneous regions, minute collaterals, meridians, and Zang-fu organs, for activating the activities of qi-blood, restoring the balance between Zang-fu organs and brain. Besides, for the yin-yang imbalance led by the spasticity of yin meridians, cutaneous needling along the three yin meridians of hand can reduce the pathogens and relieve the spasticity of tendons, regulate the functions of Zang-fu organs and meridians, and lead to the balance between excitability and inhibition.

As involving both deficiency and excess, post-stroke upper limb spasticity is intractable to treat only by single method. Aligned acupuncture at muscle regions plus cutaneous needle makes up for the limitation of single treatment method, aligned acupuncture treats the root by reinforcing yang meridians and regulating qi and blood； cutaneous needling treats the superficial by reducing yin meridians. When used together, these two methods can complement and restrict each other, thus achieving the balance among the exterior and interior, Zang-fu organs, and yin-yang.

Conflict of Interest

There was no conflict of interest in this article.

Acknowledgments

This work was supported by Scientific Research Project of Hebei Provincial Administration Bureau of Traditional Chinese Medicine (No. 2009180).

Statement of Informed Consent

Informed consent was obtained from all individual participants included in this study.

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Translator:Hong Jue

Han Shu-kai, associate chief physician of traditional Chinese medicine.

E-mail: hanshukai1975@163.com

R246.6

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Date:February 16, 2014