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Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00352248
First received: July 13, 2006
Last updated: NA
Last verified: July 1999
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Resource links provided by NLM:

U.S. FDA Resources

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 The University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00352248     History of Changes
Other Study ID Numbers: 9608944339555027
Study First Received: July 13, 2006
Last Updated: July 13, 2006
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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013