Use of Acupuncture In Children With Autistic Spectrum Disorder
|First Received Date ICMJE||July 13, 2006|
|Last Updated Date||July 13, 2006|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Use of Acupuncture In Children With Autistic Spectrum Disorder|
|Official Title ICMJE||Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder|
This is a study of the efficacy of acupuncture in children with autism.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Tongue Acupuncture (Procedure)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||3 Years to 15 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Hong Kong|
|NCT Number ICMJE||NCT00352352|
|Other Study ID Numbers ICMJE||3469296479554546|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The University of Hong Kong|
|Collaborators ICMJE||Not Provided|
|Information Provided By||The University of Hong Kong|
|Verification Date||July 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP