Osteopathic Manual Medicine Treatment in Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Other: Osteopathic Manual Medicine (Body Therapy); Other: Sham OMM

• Registration Number: NCT01676389
• Lead Sponsor: New York Institute of Technology

Brief Summary

The purpose of this study is to determine how osteopathic manual medicine (OMM) will affect core autism features including social and communication deficits. The investigators believe that OMM approaches can positively influence some features associated with Autism/Autism Spectrum Disorder (ASD).

Detailed Description

Autism is a complex neuro-developmental disorder of early childhood onset characterized by impairments in the core triad of social interaction, repetitive-stereotypes behaviors, and verbal/nonverbal communication. This major public health concern exerts an enormous toll on the quality of life of affected individuals, families, and society. Though there are medications available for use in managing autism associated behaviors, including aggression, self-injury and hyperactivity, there are no medical treatments of proven benefit in treating core autistic features such as social and communication deficits. Complementary and alternative medical treatments(CAM) are commonly used by individuals with a wide variety of medical diseases including autism despite little evidence-based support for their efficacy. Recent surveys reveal the prevalence of CAM use in children with autism to be between 30% and 95%. Osteopathic Manual Medicine (OMM) is one of the most well studied CAM treatments, achieving widening acceptance with increasing evidence of safety and efficacy, as an adjunct in the treatment of a number of conditions. OMM appears to be a safe treatment modality in the pediatric population when administered by physicians with expertise in OMM. At a physiologic level, OMM has been proposed to elicit some of its therapeutic and biomechanical effects through an ability to mobilize body fluids, increase removal of metabolic waste, and boost immune function. OMM has been shown to have favorable effects on neuro-endocrine and immunologic function. As theories of autism pathogenesis often revolve around immune dysregulation including lowered IgA levels, and accumulation of metabolic and xenobiotic agents, there are theoretical mechanisms through which OMM can exert therapeutic effects. In practice, OMM has been shown to improve sensory and motor performance with neurological problems, including autism. Additionally, studies of manual medicine techniques similar in principle to OMM, including Qigong massage and Tuina, have yielded favorable outcomes on a number of core autistic features including social, language, sensory, cognition and self-care domains as measured by the Autism Behavior Checklist (ABC) and Functional Independence Measures for Children(WeeFIM). 30 subjects will be randomized to receive OMM or sham treatments. Standardized assessment tools for autism symptom severity (ABC and WeeFIM) will be administered pre- and post-study to compare treatment efficacy between arm. Saliva samples will be collected pre- and post-treatment sessions to evaluate biochemical response and to catalog genetic markers that could provide insight into subsets exhibiting differential response.

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Study Start: 2013-01
• Status Verified: 2014-09
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• clinical diagnosis of Autism
• ages 3-11 years

Exclusion Criteria

• individuals outside the age range
• inability to provide documentation verifying Autism diagnosis
• currently receiving or previously received osteopathic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMM Hands-On Treatment	Osteopathic Manual Medicine (Body Therapy)	The Osteopathic Manual Medicine (OMM) Hands-On Treatment group will be receiving an osteopathic structural exam along with 7 gentle, non-thrusting techniques during each treatment session that lasts 20-30 minutes. The Sham treatment group will be receiving only an osteopathic structural exam that will be slowed down in order to be a similar duration to the full treatment group session (approximately 20-30 minutes).
Sham OMM	Sham OMM	Sham Osteopathic Manual Medicine (OMM)

Primary Outcome Measures

Name	Time	Method
Autism Behavior Checklist (ABC)	Enrollment, following treatment 4 (within 4-8 weeks post enrollment), and two weeks post completion of treatment 4 (within 6-10 weeks post enrollment)	This outcome measure is measuring the change from before and after each of the four treatments are administered. This is one of three primary outcomes being measured.
Salivary IgA and Salivary Cortisol	Change in baseline following treatment session 1, 2, 3 and 4 (Day 7, 14, 21, 28)	This outcome measure is measuring the change from before and after each of the four treatments are administered. This is one of three primary outcomes being measured.
WeeFIM measurement of child's functional abilities	Enrollment, following treatment 4 (within 4-8 weeks post enrollment), and two weeks post completion of treatment 4 (within 6-10 weeks post enrollment)	This outcome measure is measuring the change from before and after each of the four treatments are administered. This is one of three primary outcomes being measured.

Trial Locations

Locations (2)

Family Care Center - New York Institute of Technology College of Osteopathic Medicine; 🇺🇸 Central Islip, New York, United States

Academic Health Care Center at Old Westbury; 🇺🇸 Old Westbury, New York, United States