Use of Acupuncture In Children With Autistic Spectrum Disorder

Autism Clinical Trial

Official title:

Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352352
• Other study ID #: 3469296479554546
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: July 13, 2006

Study information

• Verified date: July 1999
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster
• Study type: Interventional

Clinical Trial Summary

This is a study of the efficacy of acupuncture in children with autism.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Procedure:
• Tongue Acupuncture (Procedure)

Locations

Country	Name	City	State
Hong Kong	Duchess of Kent of Children Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Primary	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.
Primary	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.
Primary	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.