Osteopathic Manual Medicine Treatment in Autism (OMMA)

January 19, 2016 updated by: New York Institute of Technology

Osteopathic Manual Medicine Treatment in Autism, A Pilot Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Central Islip, New York, United States, 11722
        • Family Care Center - New York Institute of Technology College of Osteopathic Medicine
      • Old Westbury, New York, United States, 11568
        • Academic Health Care Center at Old Westbury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMM Hands-On Treatment
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)
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.
Placebo Comparator: Sham OMM
Sham Osteopathic Manual Medicine (OMM)
Other: Sham OMM
Sham Osteopathic Manual Medicine (OMM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Change in baseline following treatment session 1, 2, 3 and 4 (Day 7, 14, 21, 28)
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.
Enrollment, following treatment 4 (within 4-8 weeks post enrollment), and two weeks post completion of treatment 4 (within 6-10 weeks post enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Institute of Technology

Investigators

  • Principal Investigator: David Tegay, D.O., New York Institute of Technology College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHS-760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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