Use of Acupuncture In Children With Autistic Spectrum Disorder
Primary Purpose
Autism, Autistic Disorder
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Tongue Acupuncture (Procedure)
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Traditional Chinese Medicine (TCM), Alternative Medicine (AM), Tongue Acupuncture (TAC), Autism Spectrum Disorder (ASD), Autism, Children
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Sites / Locations
- Duchess of Kent of Children Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00352352
First Posted
July 13, 2006
Last Updated
July 13, 2006
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00352352
Brief Title
Use of Acupuncture In Children With Autistic Spectrum Disorder
Official Title
Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
This is a study of the efficacy of acupuncture in children with autism.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autistic Disorder
Keywords
Traditional Chinese Medicine (TCM), Alternative Medicine (AM), Tongue Acupuncture (TAC), Autism Spectrum Disorder (ASD), Autism, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Tongue Acupuncture (Procedure)
Primary Outcome Measure Information:
Title
Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wong Virginia
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duchess of Kent of Children Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
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Use of Acupuncture In Children With Autistic Spectrum Disorder
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