Osteopathic Manual Medicine Treatment in Autism

Autism Spectrum Disorders Clinical Trial

— OMMA  

Official title:

Osteopathic Manual Medicine Treatment in Autism, A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676389
• Other study ID #: BHS-760
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: January 19, 2016
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Sham OMM
Sham Osteopathic Manual Medicine (OMM).
• 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.

Locations

Country	Name	City	State
United States	Family Care Center - New York Institute of Technology College of Osteopathic Medicine	Central Islip	New York
United States	Academic Health Care Center at Old Westbury	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (20)

Bertoglio K, Hendren RL. New developments in autism. Psychiatr Clin North Am. 2009 Mar;32(1):1-14. doi: 10.1016/j.psc.2008.10.004. Review. — View Citation

Committee on Children With Disabilities. American Academy of Pediatrics: The pediatrician's role in the diagnosis and management of autistic spectrum disorder in children. Pediatrics. 2001 May;107(5):1221-6. — View Citation

Degenhardt BF, Kuchera ML. Update on osteopathic medical concepts and the lymphatic system. J Am Osteopath Assoc. 1996 Feb;96(2):97-100. Review. — View Citation

Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. — View Citation

Frymann VM, Carney RE, Springall P. Effect of osteopathic medical management on neurologic development in children. J Am Osteopath Assoc. 1992 Jun;92(6):729-44. — View Citation

Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12. — View Citation

Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8. — View Citation

Huffman LC, Sutcliffe TL, Tanner IS, Feldman HM. Management of symptoms in children with autism spectrum disorders: a comprehensive review of pharmacologic and complementary-alternative medicine treatments. J Dev Behav Pediatr. 2011 Jan;32(1):56-68. doi: 10.1097/DBP.0b013e3182040acf. Review. — View Citation

Hundscheid HW, Pepels MJ, Engels LG, Loffeld RJ. Treatment of irritable bowel syndrome with osteopathy: results of a randomized controlled pilot study. J Gastroenterol Hepatol. 2007 Sep;22(9):1394-8. — View Citation

Jackson KM, Steele TF, Dugan EP, Kukulka G, Blue W, Roberts A. Effect of lymphatic and splenic pump techniques on the antibody response to hepatitis B vaccine: a pilot study. J Am Osteopath Assoc. 1998 Mar;98(3):155-60. — View Citation

Jerome J, Foresman B, D'Alonzo G. Biobehavioral Research in A. Chila (ed): Foundations of Osteopathic Medicine 2011Lipincott Williams & Wilkins, Phila. 1064-1074

Kidd PM. Autism, an extreme challenge to integrative medicine. Part: 1: The knowledge base. Altern Med Rev. 2002 Aug;7(4):292-316. Review. — View Citation

Lee MS, Kim JI, Ernst E. Massage therapy for children with autism spectrum disorders: a systematic review. J Clin Psychiatry. 2011 Mar;72(3):406-11. doi: 10.4088/JCP.09r05848whi. Epub 2010 Dec 28. Review. — View Citation

Levy SE, Hyman SL. Complementary and alternative medicine treatments for children with autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):803-20, ix. doi: 10.1016/j.chc.2008.06.004. Review. — View Citation

Saggio G, Docimo S, Pilc J, Norton J, Gilliar W. Impact of osteopathic manipulative treatment on secretory immunoglobulin a levels in a stressed population. J Am Osteopath Assoc. 2011 Mar;111(3):143-7. — View Citation

Silva LM, Schalock M, Ayres R. A model and treatment for autism at the convergence of Chinese medicine and Western science: first 130 cases. Chin J Integr Med. 2011 Jun;17(6):421-9. doi: 10.1007/s11655-011-0635-0. Epub 2011 Jun 10. — View Citation

Vargas DL, Nascimbene C, Krishnan C, Zimmerman AW, Pardo CA. Neuroglial activation and neuroinflammation in the brain of patients with autism. Ann Neurol. 2005 Jan;57(1):67-81. Erratum in: Ann Neurol. 2005 Feb;57(2):304. — View Citation

Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. Review. — View Citation

Warren Z, Veenstra-VanderWeele J, Stone W, Bruzek JL, Nahmias AS, Foss-Feig JH, Jerome RN, Krishnaswami S, Sathe NA, Glasser AM, Surawicz T, McPheeters ML. Therapies for Children With Autism Spectrum Disorders. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Apr. — View Citation

Weber DO. Complementary and alternative medicine. Considering the alternatives. Physician Exec. 1998 Nov-Dec;24(6):6-14. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No