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

Primary Purpose

Autistic Disorder, Autism

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Tongue Acupuncture (Procedure)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Alternative Medicine (AM), Traditional Chinese Medicine, Tongue Acupuncture, Autistic Spectrum Disorder, Autism, Children

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duchess of Kent of Children Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2006
Last Updated
July 13, 2006
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00352248
Brief Title
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
Official Title
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Autism
Keywords
Alternative Medicine (AM), Traditional Chinese Medicine, Tongue Acupuncture, Autistic Spectrum Disorder, Autism, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Tongue Acupuncture (Procedure)
Primary Outcome Measure Information:
Title
Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Title
Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Title
Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Title
Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Title
Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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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Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

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