Wang Jun, Sun Ke-xing, Wu Xu-bo

1 Rehabilitation Department, Tianshan Hospital of Traditional Chinese Medicine, Changning District of Shanghai, Shanghai 200051, China

2 Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

Effect of Individualized Needling on Gross Motor Function in Cerebral Palsy Infants

Wang Jun1, Sun Ke-xing2, Wu Xu-bo2

1 Rehabilitation Department, Tianshan Hospital of Traditional Chinese Medicine, Changning District of Shanghai, Shanghai 200051, China

2 Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

Objective: To observe the effect of individualized needling protocol (on the basis of functional brain mapping and standardized syndrome differentiation in Chinese medicine) on gross motor functions of infants with cerebral palsy (CP) and thus study the innovative means of combining acupuncture with rehabilitation management technique.

Methods: A total of 74 CP infants were randomized into a treatment group and a control group, 37 in each group. Combined individualized needling and rehabilitation training were used in the treatment group, versus combined Jin’s needling (16 brain-benefiting points) and rehabilitation training in the control group. For both groups, acupuncture treatment was conducted once every other day and rehabilitation training every day. The dynamic changes of gross motor functions before treatment and after every 1-month treatment were measured and assessed using the Gross Motor Function Measure (GMFM)-66.

Results:After treatment, the GMFM scores were significantly increased in both groups (P＜0.01); there were no between-group statistical differences in increase range of the GMFM scores (P＞0.05); the treatment protocol was not interacted with the treatment time; and the GMFM scores for spastic CP infants were better in the treatment group than that in the control group (P＜0.05).

Conclusion: Combined scalp acupuncture and rehabilitation training can produce positive effects on gross motor functions of CP infants. Individualized needling can obtain better effects than 16 brain-benefiting points in improving the gross motor functions of spastic CP infants.

Scalp Acupuncture; Scalp Stimulation Areas; Cerebral Palsy; Syndrome Differentiation Treatment; Standardization of Syndrome Differentiation; Child, Preschool

Cerebral palsy (CP) is a common nervous system disease in infants. It is distinctively characterized by motor dysfunction[1]. To date, there is little evidence suggesting that the brain damage in CP infants is reversible and the impaired function is recoverable. Due to their motility limitation, CP infants need lifelong rehabilitation care[2].

Scalp acupuncture has been extensively applied in the treatment of CP children. This includes Jiao style, Tang style, Jin style and Lin style[3-5]. The underlying theories of these different styles are Zang-xiang (Visceral Manifestation) theory in Chinese medicine, functional brain mapping and neurophysiology in modern medicine. In addition, point combination, needle insertion layers, manipulation and time of needle retaining vary in different styles. Generally, some acupuncturists mainly use one style, but some use twoor more styles. Since acupuncturists have their own experience in using certain styles, this study aims to investigate the corresponding association between scalp and brain, observe the effect of point areas in different styles, application and protocol of two or more styles, and combined scalp acupuncture and rehabilitation training, and thus explore more effective needling therapy to target the motor dysfunction in clinical practice.

1 Clinical Data

1.1 General material

A total of 74 CP cases who met the inclusion criteria were outpatients from the Clinical Rehabilitation Base in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine and Acupuncture & Tuina College, Shanghai University of Traditional Chinese Medicine between July 2007 and January 2009. Parents of these children all agreed to participate in this study and signed the informed consent. These CP cases were classified using the Gross Motor Function Classification System (GMFCS)[6]according to the age-motor function matching principle.

These CP cases were numbered by their visit sequences and then randomized into a treatment group (37 cases) and a control group (37 cases) according to the random digit table by GMFCS. There were no between-group statistical differences in general material, causative factors, disability types, classification and accompanying symptoms (P＞0.05), so the two groups were comparable (table1-4). The flow chart of clinical procedures in two groups was shown in Fig.1.

1.2 Diagnostic criteria

This was based on the diagnostic criteria established in the Second Conference of National Children Rehabilitation and the Ninth Conference of National Infantile Cerebral Palsy[7].

Table 1. Between-group comparison of CP causes (case)

Fig.1 Flow chart of clinical procedures in the two groups

Table 2. Between-group comparison of accompanying symptoms (case)

Table 3. Between-group comparison of age and disease duration ()

Table 3. Between-group comparison of age and disease duration ()

GroupsnGender (case) Disease duration (case) Male Female Average age (month) ＜1 year 1-2 years 2-3 years Treatment 37 23 14 34.3±19.6 19 12 6 Control 37 18 19 30.7±19.6 19 12 6

Table 4. Between-group comparison of pattern and classification (case)

1.3 Inclusion criteria

Those who met the above diagnostic criteria; aged 4-72 months.

1.4 Exclusion criteria

Those who could not tolerate needling; with complication of uncontrolled epilepsy; with hemorrhagic tendency and a poor coagulation function; and those with visual, hearing or intelligence disorders that might affect rehabilitation measurement and assessment.

1.5 Termination criteria

Those who could not continue the trial due to severe adverse reactions or other unexpected events; those with an increasingly aggravated condition during the trial; and families of CP infants were reluctant to continue the trial.

1.6 Rejection and dropout criteria

Those who did not receive standard treatment; with less than 1/2 of a treatment course; those who spontaneously dropped out during the trial; and researchers assumed that continuing trial might harm the subjects.

2 Treatment Methods

2.1 Treatment group

Major acupoints: Sishencong (EX-HN 1), Motor Area (Jiao style, selecting corresponding segments according to dysfunctional areas) and Balance Area (Jiao style).

Adjunct acupoints: Add Premotor Area (Lin style) and Ashi points (tendon spindle area of spastic muscle groups) for spastic CP; added Usage Area (Jiao style) and Three Temporal Needles (Lin style) for involuntary movement CP; added Usage Area (Jiao style) for a poor motor coordination; added Five Forehead Needles (Lin style) for mental retardation; and added Premotor Area (Lin style) for hypertonia.

Based on syndrome differentiation, combine with Shenshu (BL 23) and Taixi (KI 3) for kidney deficiency and combine with Zusanli (ST 36) and Taixi (KI 3) for deficiency of the spleen and kidney.

Operation: Puncture the above body acupoints using sterile needles of 0.30 mm in diameter, conduct 10 times of lifting, thrusting and twirling and then withdraw the needles. For scalp points/area, puncture 0.5-0.8 cun with filiform needles of 25 mm in length, conduct 10 times of twirling and retain the needles for 1 h. For Ashi points, first extend the spastic muscle groups to a maximum degree and then puncture towards the eccentric contraction using filiform needles of 50 mm in length, conduct heavy lifting and thrusting for a couple of times and withdraw the needles upon the feeling of immediate relief of hypertonia.

The above acupuncture treatment was performed once every other day.

2.2 Control group

Major acupoints: Jin’s 16 brain-benefiting points, including Three Wisdom Needles, Sishencong (EX-HN 1), Three Temporal Needles (both sides), and Three Brain Needles.

Operation: Same as the treatment group, once every other day.

2.3 Observation indexes

These include modified Ashworth Scale and GMFM-66. Trained specialists or therapists who were not involved in the grouping and treatment recorded and evaluated each item of CP infants according to the GMFM-66 assessment method and scoring standard[8-9]. In addition, each evaluation form was examined and verified by personnel who were not involved in the grouping and treatment.

2.4 Treatment safety evaluation

Possible accidents including faint from needling, bent, stuck or broken needles, subcutaneous hemorrhage and abnormal sensations after needling were honestly recorded in details, followed by an analysis and subsequent prevention and management principles and methods. Subjects can suspend or terminate the trial in case they do not feel well. The safety evaluation criteria are as follows.

Level 1: Safe without above abnormal events.

Level 2: Relatively safe and no need for special management of abnormal events.

Level 3: Moderate safety issues but treatment can continue after management.

Level 4: Treatment has to be terminated because of abnormal events.

3 Treatment Outcomes

3.1 Statistical method

The SPSS 13.0 version software was used for statistical analysis, two-sided test for statistical test,P=0.05 for significance level, Chi-square test for numeration data, and () for measurement data. Necessary analysis of variance on repeated measurement data was also used in the study.

3.2 Treatment results

3.2.1 Comparison of GMFM score between the two groups

In summary, 3 cases in the observation group dropped out, while 4 cases dropped out and 2 cases terminated the trial in the control group. During and after the treatments, the initial (1 month after treatment), middle (2 months after treatment) and late-stage (after the treatment course is over) gross motor functions in two groups were measured and assessed using GMFM-66. GMFM score calculation using the GMAE (Version1.0)[8]and statistical analysis on GMFM scores showed that there were intra-group statistical differences (P＜0.01) in the initial, middle and late-stage GMFM scores, indicating that combined acupuncture and rehabilitation training could effectively improve the motor functions of CP infants (table 5).

Table 5. Between-group comparison in GMFM scores (, point)

Table 5. Between-group comparison in GMFM scores (, point)

Note: Compared with the intra-group results before treatment, 1)P＜0.05

GroupsnBefore treatment After treatment 1 month 2 months 3 months Treatment 34 47.0±16.1 49.0±16.31)50.7±15.81)52.3±16.11)Control 31 40.6±17.3 42.9±16.41)44.3±16.41)45.9±16.31)

3.2.2 Modified Ashworth Scale comparison of spastic CP infants

Modified Ashworth Scales were assessed on the muscle tone of bilateral triceps surae muscles (excluding hemiplegia) of 11 spastic CP infants before and after treatments. Results showed that there was statistical significance in modified Ashworth Scales before and after treatments (χ2=10.30,P＜0.05), indicating that combined acupuncture and rehabilitation training could effectively improve the motor functions of spastic CP infants (table 6).

Table 6. Comparison of modified Ashworth scale in spastic CP infants (case)

3.2.3 GMFM score comparison between the spastic CP infants in the two groups

There were 20 spastic CP infants in the treatment group and 15 in the control group. After one course of treatment, the initial, middle and late-stage gross motor functions of spastic CP infants in two groups were measured and assessed using GMFM scale. Results have shown that there were intra-group statistical differences (P＜0.01) in the initial, middle and late-stage GMFM scores, indicating that combined acupuncture and rehabilitation training could effectively improve the motor functions of spastic CP infants. Results also showd that there were between-group statistical differences (P＜0.05) in the initial, middle and late-stage GMFM scores, indicating that individualized acupuncture therapy could relieve the spasticity of CP infants and obtain better effects than the control group in improving the motor functions of spastic CP infants (table 7).

3.2.4 GMFM score comparison of CP infants without spastic between the two groups

There were 15 CP infants without spastic in the treatment group and 15 cases in the control group. After one course of treatment, the initial, middle and late-stage gross motor functions of CP infants without spastic in the two groups were measured and assessed using GMFM scale. Results have shown that there were between-group statistical differences (P＜0.01) in the initial, middle and late-stage GMFM scores, indicating that combined acupuncture and rehabilitation training could effectively improve the motor functions of CP infants without spastic (table 8).

3.3 Safety evaluation of curative effects of CP infants in the two groups

According to the safety evaluation, CP infants receiving acupuncture treatment showed 100% of level 1 and 2 without level 3 and 4, indicating that acupuncture was a safe therapy for CP.

4 Discussion

Acupuncture has been extensively used for rehabilitation of CP-related disorders, especially for motor dysfunction. Clinical studies on acupuncture for CP have proven that comprehensive therapy can obtain better effect than a single therapy. However, comprehensive therapy is often nothing but an overlap of simple methods; and few studies are available regarding the modality and means of combination of these methods[10]. Consequently, in addition to showing the effect of individualized acupuncture therapy on gross motor functions of CP infants by the previous small-sample self-controlled study, we also developedthis randomized clinical trial containing a certain sample size.

Table 7. Between-group comparison in spastic CP infants’ GMFM scores (, point)

Table 7. Between-group comparison in spastic CP infants’ GMFM scores (, point)

Note: Compared with the intra-group results before treatment, 1)P＜0.05; compared with the concurrent control group, 2)P＜0.05

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Table 8. Between-group comparison in nonspastic CP infants’ GMFM scores (, point)

Table 8. Between-group comparison in nonspastic CP infants’ GMFM scores (, point)

Note: Compared with the intra-group results before treatment, 1)P＜0.05

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Referring to the correlation factor analysis of International Classification of Functioning (ICF )[11]on CP-related disorders, this study has preliminarily suggested that the direct effect of acupuncture for motor dysfunction of CP infants manifests in structural and somatic dysfunction (abnormal muscles tones including hypertonia, hypotonia or dysmyotonia, limited range of joint motion, sensory perception disturbance and associated symptoms including drooling, epilepsy, visual/hearing disorders, deglutition disorders and mental retardation). Since CP infants are susceptible to other problems such as sleep disorder, indigestion, hypo-immunity and a weak constitution, which can in turn hinder their functional recovery, acupuncture intervention based on the holistic view of Chinese medicine can directly regulate the children’s body and indirectly improve their motor function development. A statistical significance (P＜0.05) in modified Ashworth Scales and constituent ratios of 11 spastic CP infants before and after treatment has demonstrated the positive effect of acupuncture for relief of spasticity. This is consistent with the research findings on acupuncture for CP by Tan CJ, et al[12]. The Premotor Area and Ashi points are mainly used for spastic CP. Clinical observation has shown that Ashi points have significant immediate effect on decreasing the muscle tone. This can probably be explained as follows: a strong needling stimulation activates the Golgi tendon organs within the tendon spindle, the activated impulse is then transmitted to the spinal cord through type Ib nerve fiber, causing antagonist facilitation of spastic muscle groups through the intercalated neurons, and thus inhibiting the prime movers to relieve spasticity[13]. Further studies will be needed to demonstrate the accurate mechanism for spasticity relief.

The CP infants’ compliance was also analyzed in this study: 3 cases in each group dropped out, 2 terminated the trial and 1 obtained clinical recovery. For spastic and nonspastic CP infants who completed the 3-month clinical observation, the curative effect analysis of GMFM has shown that there was no between-group statistical difference in treatment protocols (P＞0.05); however, for two groups of spastic CP infants, there was between-group statistical significance in GMFM scores (P＜0.05). This is probably because the gross motor functions of CP infants without spastic (hypotonia, involuntary movement, ataxia or mixed type) are often worse than spastic CP infants. In addition, due to a small sample size of CP infants without spastic, this study failed to conclude the effect of individualized scalp acupuncture for their gross motor function. An extended time will be needed to further observe the effect of individualized acupuncture on gross motor functions of CP infants without spastic. Additionally, a large-sample multi-center clinical observation will be needed to further investigate the effect of individualized scalp acupuncture on gross motor function of CP groups without spastic.

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Translator: Han Chou-ping

Received Date: November 5, 2012

R246.4

A

s in both groups

physical and occupational therapies. Physiotherapy consists of 45-minute neurodevelopment therapy and occupational therapy consists of 30-minute fine activities of the upper limbs and cognitive training. The physical and occupational therapies were performed once every day, and 3 months made up a course of treatment. The compliance and clinical reactions of CP infants were recorded by personnel who were not involved in the grouping, treatment and assessment.

Author: Wang Jun, physician. E-mail: sunkexing@hotmail.com