Osteopathic Manual Medicine Treatment in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Sham OMM; Osteopathic Manual Medicine (Body Therapy)
Intervention type(s): Other; Other
Intervention description(s): Sham Osteopathic Manual Medicine (OMM).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders