Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder - Full Text View

Purpose

We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.

Condition	Intervention	Phase
Autistic Disorder Autism	Procedure: Tongue Acupuncture (Procedure)	Phase III

MedlinePlus related topics:

Acupuncture Autism

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.

Estimated Enrollment:

50

Detailed Description:

In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).

Eligibility

Ages Eligible for Study:	3 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with diagnosis of autism 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 and with a score for Childhood Autism Rating Scale (CARS) greater than 30.

Exclusion Criteria:

Children with associated neurological disorders and epilepsy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352248

Locations


Hong Kong
	Duchess of Kent of Children Hospital
	Hong Kong, Hong Kong

Sponsors and Collaborators

The University of Hong Kong

Investigators


Principal Investigator:	Wong Virginia	University of Hong Kong

More Information

Study ID Numbers:	9608944339555027
First Received:	July 13, 2006
Last Updated:	July 13, 2006
ClinicalTrials.gov Identifier:	NCT00352248
Health Authority:	HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster

Keywords provided by The University of Hong Kong:

Alternative Medicine (AM)

Traditional Chinese Medicine

Tongue Acupuncture

Autistic Spectrum Disorder

Autism

Children

Study placed in the following topic categories:

Child Development Disorders, Pervasive

Developmental Disabilities

Mental Disorders

Autistic Disorder

Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	The University of Hong Kong
Information provided by:	The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00352248