Han Shu-kai (韓淑凱), Hao Hai-yan (郝海燕), Liu Feng-hui (劉鳳輝), Li Qing (李卿), Li Xue-fei (李學(xué)飛), Yang Wei-hong (楊偉紅)

1 Wangdu County Hospital of Chinese Medicine, Hebei 072450, China

2 Laishui County Hospital, Hebei 074100, China

3 Gaoling Township Health Center, Wangdu County, Hebei 072450, China

4 Dingxing County Hospital, Hebei 072650, China

5 Affiliated Hospital of Hebei University, Hebei 071000, China

Clinical Study

Effect of row needling in muscle regions combined with seven-star needle tapping on cognitive function and quality of life in patients with post-stroke upper limb spasticity

Han Shu-kai (韓淑凱)1, Hao Hai-yan (郝海燕)2, Liu Feng-hui (劉鳳輝)2, Li Qing (李卿)3, Li Xue-fei (李學(xué)飛)4, Yang Wei-hong (楊偉紅)5

1 Wangdu County Hospital of Chinese Medicine, Hebei 072450, China

2 Laishui County Hospital, Hebei 074100, China

3 Gaoling Township Health Center, Wangdu County, Hebei 072450, China

4 Dingxing County Hospital, Hebei 072650, China

5 Affiliated Hospital of Hebei University, Hebei 071000, China

Objective:To observe the effect of row needling in muscle regions combined with seven-star needle tapping on cognitive function and quality of life (QOL) in patients with post-stroke upper limb spasticity.

Methods:A total of 448 eligible cases were randomly allocated into a treatment group and a control group, 244 in each group. Based on standard conventional treatment, cases in the treatment group received row needling in muscle regions combined with seven-star needle tapping, whereas cases in the control group took oral Western medication. After 3 weeks of treatment, the cognitive functions were assessed using comprehensive functional assessment (CFA) and mini-mental state examination (MMSE). The QOL was evaluated using the Chinese-version 36-item short-form health survey (SF-36).

Results:After treatment, the CFA and MMSE scores were significantly improved in both groups (P＜0.05); and there were between-group statistical differences (P＜0.05), showing a better effect in the treatment group than that in the control group. In addition, there were between-group statistical significances in scores of QOL (P＜0.05, P＜0.01).

Conclusion:Row needling in muscle regions combined with seven-star needle tapping can significantly improve the cognitive function and QOL of patients with post-stroke upper limb spasticity.

Acupuncture Therapy; Cutaneous Acupuncture; Muscle Spasticity; Poststroke Syndrome; Cognition Disorders; Quality of Life

Stroke severely affects general population in China. It is characterized by high rates of morbidity, disability and relapse, and greatly endangers human health. Approximately 89% stroke survivors may develop functional disturbances in varying degrees. Spastic paralysis is a common pathologic process during stroke recovery. Muscle spasticity in most stroke patients affects recovery of the limb function. The daily quality of life (QOL) relies on normal motor function of the upper limbs. As a result, the upper limb spasticity often affects the patients’ QOL.To explore an effective treatment protocol for poststroke upper limb spasticity, we’ve adopted a multicenter randomized controlled clinical trial to measure and evaluate how row needling in muscle regions combined with seven-star needle tapping improves the patients’ cognitive function and QOL. The results are now summarized as follows.

1 Clinical Data

1.1 Diagnostic criteria

The diagnosis of cerebral infarction and cerebral hemorrhage was based on the Key Diagnostic Points for Cerebrovascular Diseases[1], coupled with skull CT scan or MRI examination. The diagnosis of upper limb spasticity was based on Clinical Practice Guidelines: Physical Medicine and Rehabilitation[2]: increased resistance in passive motion of the upper limb, joint rigidity in flexion or extension in severe spasticity; local joint and muscle pain and muscle or tendon contracture induced by long-time spasm; tendon hyperreflexia of the spastic upper limb; and limitations of the upper limb motor function and daily activities.

1.2 Inclusion criteria

Those who met the above diagnostic criteria; aged between 47 and 80 years with stable vital signs and clear consciousness; grade 1-4 of spasticity (according to modified Ashworth scale (MAS) (including grade 1 but excluding grade 4) and grade II-V of Brunnstrom stages; having a duration of less than 3 months; and voluntarily participated in the study and signed the informed consent.

1.3 Exclusion criteria

Those having unstable, critical or acute medical conditions; having disturbance of consciousness or severe cognitive impairment; having complications of severe heart, lung, liver and kidney conditions, diabetes or hemorrhagic tendency; and having been taking sedatives or muscle relaxants.

1.4 Rejection and termination criteria

Those who failed to follow the treatment protocol with a poor compliance; those who couldn’t continue with the treatment due to severe adverse reactions or events; those who need emergent measures due to severe complications or deterioration.

1.5 Statistical method

1.6 General materials

The therapeutic efficacies of 488 cases treated at Wangdu County Hospital of Chinese Medicine, Affiliated Hospital of Hebei University, Baoding No.1 Hospital of Traditional Chinese Medicine and No.252 Hospital of the Chinese People's Liberation Army between March 2007 and March 2013 were observed and the database of these cases was set up, 122 cases in each center. There were 362 inpatients and 126 outpatients. The 488 cases were randomly allocated into a treatment group and a control group, 244 in each group. Cases in the treatment group were aged between 45 and 72 years, and their duration lasted from 7 d to 2 months. Cases in the control group were aged between 47 and 81 years and their duration lasted from 6 d to 2 months. There were no between-group statistical differences in general materials (all P＞0.05), indicating that the two groups were comparable (Table 1).

Table 1. Between-group comparison of general materials

1.7 Clinical trial design method

This study adopted a multi-center, randomized, controlled clinical trial design. There were four centers, a treatment group and a control group in each center. There were at least 60 cases in each center. A total of 480 cases were recruited. Considering a 15% dropout rate, the samples were expanded to 552 cases. Randomization was performed in each center simultaneously using the Visual-Basic 6.0 version software. The case ratio between the treatment group and the control group was 1:1. With random allocation concealment, patients were allocated into a treatment or control group by random envelope method. The study then started upon approval by the Ethics Committee and signature of patients on the informed content. To ensure the measurement quality, the survey crew was trained prior to the study. This study used multiple observation methods.

2 Treatment Methods

2.1 Treatment group

The meridians in upper limbs were divided into three groups according to interior-exteriorly connected relationship of the twelve regular meridians: the Lung Meridian with the Large Intestine Meridian, the Pericardium Meridian with the Triple Energizer Meridian, and the Heart Meridian with the Small Intestine Meridian.

2.1.1 Seven-star needle tapping

Tapping area: A seven-star needle was used to tap along the Lung, Pericardium and Heart Meridians, especially the Five Shu-Transmitting points, Yuan-Primary points, Luo-Connecting points, Xi-Cleft points and points around the joints. For internal rotation of the upper limb, medial border of the shoulder blade was also tapped.

Method: After sterilizing with 75% alcoholic cotton ball, the practitioner held the handle of the seven-star needle with the thumb and middle finger of the right hand, placed index finger on the upper part of the handle, used the ring and small fingers to immobilize the handle to the hypothenar, and tapped the above areas with moderate force (exerting force from the wrist until the local area turned red but not bled). The needle tip was perpendicular to the skin.

The treatment was done once a day, two meridians for each treatment, and seven times made up a course of treatment.

2.1.2 Row needling in muscle regions

Points: Five Shu-Transmitting (Jing-Well, Ying-Spring, Shu-Stream, Jing-River and He-Sea) points, Jianjing (GB 21), Jianliao (TE 14) and Jianzhen (SI 9).

Methods: The patient took a supine lying position. Filiform needles of 0.25 mm in diameter and 50 mm in length were used in this study. Bloodletting method was applied to Jing-Well points. The other points were needled perpendicularly to the superficial layer of tendons. One needle was inserted every 1-2 cun along the line connecting two adjacent points (5-7 points for each line), followed by reinforcing manipulation upon needling sensation every 10 min. The needles were retained for 30 min. The treatment was done once a day, 7 d for a course of treatment.

The treatment sequence was as follows: tap the three yin meridians of hand with a seven-star needle, row needling in muscle regions and then tap the three yang meridians of hand.

2.2 Control group

Patients received intravenous dripping of 4 g Piracetam Injection (manufactured by Shandong Lukang Cisen Pharmaceutical Co. Ltd., China Food and Drug Administration approval number: H20045019,) and 20 mL Cerebroprotein Hydrolysate in 250 mL 0.9% saline once a day, 7 d for a course of treatment. The therapeutic efficacies were evaluated after 3 courses of treatment.

3 Therapeutic Efficacy Observation

3.1 Measurement parameters

3.1.1 Cognitive function

The cognitive functions of patients in both groups were evaluated using comprehensive functional assessment (CFA)[3-4]and mini-mental state examination (MMSE)[5].

3.1.2 QOL

The Chinese-version 36-item short-form health survey (SF-36)[6]was used to evaluate the patients’ QOL. It covers 36 questions in physical, mental and subjective health summary measures, including an 8-scale profile of functional health and 1 change of health (CH). A higher score defines a more favorable QOL.

Physical function (PF): To evaluate limitations in physical activities because of health problems.

Role-physical (RP): To measure interference with work or other daily activities due to physical problems.

Bodily pain (BP): To measure pain intensity and limitations in daily activities due to pain.

General health (GH): To measure personal perception regarding health status and development tendency.

Vitality (VT): To measure personal perception regarding energy and fatigue.

Social functioning (SF): To measure the degree to which individual’s emotional or physical problems disrupt his/her normal (quantity and quality) social activities.

Role-emotional (RE): To measure the degree to which individual’s emotional problems interfere with his/her work or other daily activities.

Mental health (MH): To measure four categories of mental health items: motivation, depression, anger or emotional outburst and subjective feeling.

Each item was scored according to the score conversion.

Score conversion ＝ (Actual score － The lowest possible score) ÷ (The highest possible score － The lowest possible score) × 100%.

Before the SF-36 form was filled in, it’s necessary to interview with the patients and explain the research objective, followed by one-to-one questionnaire survey to make sure they answer every question according to their actual health state. For illiteracy patients, a nursewas assigned to read each question. It’s important for the nurse to stay neutral and not give any hints while reading questions.

3.2 Results

3.2.1 Between-group comparison of cognitive functions

After treatment, the CFA and MMSE scores were significantly improved in both groups (P＜0.05); and there were between-group statistical differences in CFA and MMSE scores (P＜0.05), indicating a better improvement in cognitive function in the treatment group than that in the control group (Table 2).

3.2.2 Between-group comparison of QOL

After treatment, the scores of QOL in the treatment group were significantly higher than that in the control group (P＜0.05, P＜0.01), indicating a better effect in the treatment group than that in the control group (Table 3).

Table 2. Between-group comparison of cognitive function before and after treatment

Table 2. Between-group comparison of cognitive function before and after treatment

Note: Intra-group comparison before and after treatment, 1) P＜0.05; compared with the control group after treatment, 2) P＜0.05

Group nTime FCA MMSE Treatment 244Before treatment 20.46±5.62 23.59±3.21 After treatment 25.97±7.331)2)28.91±2.011)2)Control 244Before treatment 21.03±6.48 23.06±3.57 After treatment 23.42±6.851)25.12±2.331)

Table 3. Between-group comparison of QOL before and after treatment

Table 3. Between-group comparison of QOL before and after treatment

Note: Compared with the control group, 1) P＜0.05; 2) P＜0.01

Group n PF RP BP GH VT SF RE MH CH Treatment 244 79.4±21.72)52.7±34.21)74.3±16.51)56.9±14.81)72.9±12.21)75.6±12.41)73.1±21.22)79.6±10.32)59.2±13.31)Control 244 60.1±25.7 37.5±21.3 62.1±18.4 46.9±13.7 61.8±13.1 65.9±13.1 54.6±26.3 67.2±11.4 47.7±16.3

4 Discussion

Stroke frequently affects the middle-aged and elderly population and can greatly endanger human health. Approximately 89% of stroke survivors may develop functional disorders. Spastic paralysis is a common pathologic process during stroke recovery. It can severely affect the patient’s limb function and cause economic burden to families and society. In addition to limb function, stroke patients may also manifest dysfunctions in cognitive ability. Over the recent years, along with the transformation of new biopsychosocial medical model, the focuses of evaluation on diseases and clinical efficacy have gradually turned to physiology, psychology and social functioning, especially the patient’s QOL.

In Chinese medicine, post-stroke upper limb spasticity falls under the category of ‘wind stroke’ and ‘spasm syndrome’. Contributing factors include wind-phlegm obstructing the meridians, disorders of qi and blood, malnourishment of tendons and yin-yang imbalance. This condition is characterized by ‘flaccidity in the yang side and spasticity in the yin side’. The three yang meridians of hand pertain to Fu organs and connect with Zang organs, whereas the three yin meridians of hand pertain to Zang organs and connect with fu-organs. The three yang meridians of hand and three yin meridians of hand are internal-externally connected. Consequently, this study established the treatment strategy of reinforcing deficiency, reducing excess and balancing yin and yang by row needling along the muscle regions.

Muscle regions are external connecting parts of the twelve regular meridians, referring to tendons, muscles and regions where qi and blood of the twelve regular meridians gather. They often originate from the four extremities (between finger/toe nails) and terminate over the head and face. Muscle regions act to circulate qi and blood, soften tendons and bones, lubricate joints and contribute to motor system of the body. Since they travel superficially, muscle regions are easily affected by external pathogens. Main pathogenic factors affecting muscle regions include phlegm, deficiency and stasis. Invasion by external pathogens or acute lesion may impair anti-pathogenic qi and result in phlegm-stasis in meridians and subsequently, disorders of muscle regions. This study adopted row needling of muscle regions of the three yang meridians of hand to harmonize qi and blood to alleviate flaccidity and also to unblock meridians and lubricate joints to activate flaccid muscle regions.

The stroke affects the brain. All three yang meridians of hand ascend to the head. Since meridians are indicated for problems along the pathway of meridians, stimulating the muscle regions along the upper limbs can refresh the mind, activate meridian qi and blood and thus nourish muscle regions and benefit recovery of the upper limb functions.

In addition, row needling in muscle regions can extensively stimulate nerves of the upper limb, improve neurotrophy and excitability, boost metabolism of nerve tissue and speed up recovery of affected nerves. This method can also increase local circulation of blood,generate muscle contraction on the flaccid limb and improve the muscle tone.

Cutaneous regions are superficial divisions of the twelve regular meridians on the surface of the body. External pathogenic factors often affect the cutaneous regions first and transmit into Zang-fu organs via meridians. On the other hand, problems of Zang-fu organs may manifest on cutaneous regions via meridians. Consequently, stroke patients may have ropy band of fibers along the pathways of three yin meridians of hand. That’s why we adopted seven-star needling tapping cutaneous regions of the three yin meridians of hand in this study, with the goal of harmonizing Zang-fu organs and brain and balancing excitability and inhibition through optimally stimulating cutaneous regions, minute collaterals, collaterals, meridians and Zang-fu organs. Previous studies have suggested that acupuncture can reflexively excite cerebral cortex, accelerate blood flow, increase brain cell activity, speed up the absorption of focal lesion, and facilitate the compensation of undamaged cells. In addition, it can activate brain cells in an inhibitory state and benefit recovery of the limb function[7].

The study findings regarding the effect of row needling in muscle regions combined with seven-star needling tapping for post-stroke upper limb spasticity have shown that there were between-group statistical differences in comparing CFA and MMSE scores (P＜0.05), indicating that this method can significantly improve the patient’s cognitive function. The SF-36 includes an 8-scale profile of physical and mental health summary measures. It has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments[8]. Accordingly, it has better reliability, validity and reactivity. After treatment, the QOL scores in the treatment group were significantly higher than that in the control (P＜0.05 or P＜0.01), indicating that row needling in muscle regions combined with sevenstar needle tapping can substantially improve the patient’s QOL.

Clinical studies have confirmed the distinctive effect of acupuncture for stroke[9-11]. Based on continuous circulation of qi and blood through meridians and holistic view in Chinese medicine, this study adopted row needling in muscle regions combined with sevenstar needle tapping therapy to regulate the whole body and balance yin and yang. As a result, this method can increase stimulation to points and activate functions of meridians and points. Additionally, the two methods can integrate reinforcing and reducing, connect the interior with the exterior, achieve yin-yang balance and work well for post-stroke upper limb spasticity.

Conflict of Interest

The authors declared that 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 (河北省中醫(yī)藥管理局科研計(jì)劃項(xiàng)目, No. 2009180).

Statement of Informed Consent

All of the patients signed the informed consent.

Received: 30 August 2014/Accepted: 12 October 2014

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Translator: Han Chou-ping (韓丑萍)

經(jīng)筋排刺配合皮膚針療法對腦卒中后上肢痙攣患者認(rèn)知功能及生活質(zhì)量的影響

目的: 觀察經(jīng)筋排刺配合皮膚針療法對腦卒中后上肢痙攣患者認(rèn)知功能及生活質(zhì)量的影響。方法: 將488例腦卒中后上肢痙攣患者隨機(jī)分為治療組和對照組, 每組244例, 在必要康復(fù)治療的基礎(chǔ)上, 治療組給予經(jīng)筋排刺配合皮膚針療法, 對照組給予常規(guī)西藥治療。兩組均連續(xù)治療3星期后觀察療效。采用功能綜合評定量表(functional comprehensive assessment, FCA)和簡易精神狀態(tài)檢查量表(mini-mental state examination, MMSE)評價患者認(rèn)知功能；采用健康狀況調(diào)查問卷(36-item short-form health survey, SF-36)中文版評價患者的生活質(zhì)量。結(jié)果:治療后, 兩組FCA、MMSE評分均較治療前有明顯改善(P＜0.05), 且治療組改善情況均優(yōu)于對照組, 兩組間差異均有統(tǒng)計(jì)學(xué)意義(P＜0.05)。治療組患者各項(xiàng)生活質(zhì)量評分均明顯高于對照組, 差異有統(tǒng)計(jì)學(xué)意義(P＜0.05, P＜0.01)。結(jié)論: 經(jīng)筋排刺配合皮膚針療法能明顯改善腦卒中后上肢痙攣患者的認(rèn)知功能, 提高其生活質(zhì)量。

針刺療法; 皮膚針療法; 肌痙攣; 中風(fēng)后遺癥; 認(rèn)知障礙; 生活質(zhì)量

R246.6 【

】A

in both groups

anti-spasm rehabilitation training, such as placing of normal upper limb position, maintaining the joint range of motion, alleviation of body motion control points around the spasm, static muscle stretch, passive movement and massage.

Author: Han Shu-kai, vice chief physician.

E-mail: hanshukai1975@163.com