Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
研究概览
简要总结
This is a study of the efficacy of acupuncture in children with autism.
详细描述
Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior.
Acupuncture had been practiced in China for over two millennia. In Traditional Chinese Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. The approach in TCM, in sharp contrast to western medical concept, was a "holistic" approach with a philosophical background of balancing the "Yin-and-Yang". The main objective of TCM was to improve health of body and mind by deblocking the flow of "Qi" in the body. The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" or "Qi" ["de-qui" in Chinese]. The effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. Thus, acupuncture is especially effective in chronic disorders, especially neurological ones.
As there is no TCM concept of mental retardation or autism, we propose that ASD is part of the spectrum of the TCM concept of the "Four Delayed Syndrome" in children with "delay in motor skills, speech, hair and teeth eruption" according to TCM concept. Thus, we approach ASD according to TCM concept as part of the lower intelligence due to imbalance of "Heart meridian and Kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem and "Liver meridian" (yin-yang imbalance) leading to behavioral problems.
Our objective is to use a different approach in looking at ASD and to assess the efficacy of TCM model in improving the functional status of these children. Specific acupoints corresponding to various organs and meridians were used for ASD. The organ and meridian concept in TCM model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of ASD or autism was made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised (ADI-R).
- •The diagnosis of autism was made if it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).
排除标准
- •Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
结局指标
主要结局
Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Functional Independence Measure for children (WeeFIM) consists of 18 questions concerning on the Functional Independence Measure for children, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Parental Stress Index (PSI) consists of child domain, parent domain and a total domain, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Clinical Global Impression Scale (CGIS) is a measure in a Likert scale of 0 - 7, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
次要结局
未报告次要终点