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

Phase 3

Completed

• Conditions: Autistic Disorder; Autism

• Registration Number: NCT00352248
• Lead Sponsor: The University of Hong Kong

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).

Study Timeline

• Status Verified: 1999-07
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Last Update Submitted: 2006-07-13
• Study First Posted: 2006-07-14
• Last Update Posted: 2006-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duchess of Kent of Children Hospital; 🇭🇰 Hong Kong, Hong Kong