Osteopathic Manual Medicine Treatment in Autism (OMMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by New York Institute of Technology
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT01676389
First received: July 16, 2012
Last updated: February 11, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Autism Spectrum Disorders
Other: Sham OMM
Other: Osteopathic Manual Medicine (Body Therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Osteopathic Manual Medicine Treatment in Autism, A Pilot Study

Resource links provided by NLM:


Further study details as provided by New York Institute of Technology:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change in baseline following treatment session 1, 2, 3 and 4 (Day 7, 14, 21, 28) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of Autism
  • ages 3-8 years

Exclusion Criteria:

  • individuals outside the age range
  • inability to provide documentation verifying Autism diagnosis
  • currently receiving or previously received osteopathic treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676389

Contacts
Contact: David Tegay, D.O. 516-686-3757 Autismresearch@nyit.edu

Locations
United States, New York
Family Care Center - New York Institute of Technology College of Osteopathic Medicine Recruiting
Central Islip, New York, United States, 11722
Academic Health Care Center at Old Westbury Recruiting
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: David Tegay, D.O. New York Institute of Technology College of Osteopathic Medicine
  More Information

Publications:

Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT01676389     History of Changes
Other Study ID Numbers: BHS-760
Study First Received: July 16, 2012
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York Institute of Technology:
Autism Spectrum Disorders

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014