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OpenTrials
Completed

NCT Number: NCT01676389

Osteopathic Manual Medicine Treatment in Autism

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).

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham OMM

Other

Sham Osteopathic Manual Medicine (OMM).

Osteopathic Manual Medicine (Body Therapy)

Other

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.

Primary outcomes

  1. Autism Behavior Checklist (ABC)

    Time frame: 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.

  2. Salivary IgA and Salivary Cortisol

    Time frame: 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.

  3. WeeFIM measurement of child's functional abilities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

Osteopathic Manual Medicine Treatment in Autism, A Pilot Study

Acronym: OMMA

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 30, 2012
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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