Osteopathic Manual Medicine Treatment in Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Osteopathic Manual Medicine Treatment in Autism, A Pilot Study

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Other: Sham OMM
* Other: Osteopathic Manual Medicine (Body Therapy)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMM Hands-On Treatment<br>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). | Other: Osteopathic Manual Medicine (Body Therapy)<br>* OMM techniques include the following - paraspinal soft tissue myofascial release, rib raising, cervical spine soft tissue myofascial release, suboccipital inhibition, thoracic balanced ligamentous tension technique, thoracic lymphatic pump and pedal lymphatic pump.<br>|
| Placebo Comparator: Sham OMM<br>Sham Osteopathic Manual Medicine (OMM) | Other: Sham OMM<br>* Sham Osteopathic Manual Medicine (OMM).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Behavior Checklist (ABC) | 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. | Enrollment, following treatment 4 (within 4-8 weeks post enrollment), and two weeks post completion of treatment 4 (within 6-10 weeks post enrollment) | 
| Salivary IgA and Salivary Cortisol | 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. | Change in baseline following treatment session 1, 2, 3 and 4 (Day 7, 14, 21, 28) | 
| WeeFIM measurement of child's functional abilities | 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. | Enrollment, following treatment 4 (within 4-8 weeks post enrollment), and two weeks post completion of treatment 4 (within 6-10 weeks post enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorders