NCT01676389

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

July 16, 2012

Last Update Submit

January 19, 2016

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

OMM Hands-On Treatment

EXPERIMENTAL

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)

Sham OMM

PLACEBO COMPARATOR

Sham Osteopathic Manual Medicine (OMM)

Other: Sham OMM

Interventions

Sham OMMOTHER

Sham Osteopathic Manual Medicine (OMM).

Sham 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.

OMM Hands-On Treatment

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of Autism
  • ages 3-11 years

You may not qualify if:

  • individuals outside the age range
  • inability to provide documentation verifying Autism diagnosis
  • currently receiving or previously received osteopathic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Care Center - New York Institute of Technology College of Osteopathic Medicine

Central Islip, New York, 11722, United States

Location

Academic Health Care Center at Old Westbury

Old Westbury, New York, 11568, United States

Location

Related Publications (20)

  • 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. Report No.: 11-EHC029-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK56343/

    PMID: 21834171BACKGROUND

  • 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.

    PMID: 21208598BACKGROUND

  • 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. doi: 10.1542/peds.107.5.1221.

    PMID: 11331713BACKGROUND

  • 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.

    PMID: 21160435BACKGROUND

  • 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.

    PMID: 18775371BACKGROUND

  • 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. doi: 10.1001/jama.280.18.1569.

    PMID: 9820257BACKGROUND

  • 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.

    PMID: 19248913BACKGROUND

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

    PMID: 10351720BACKGROUND

  • 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.

    PMID: 15710659BACKGROUND

  • 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. doi: 10.7556/jaoa.1996.96.2.113.

    PMID: 8838907BACKGROUND

  • 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. doi: 10.1111/j.1440-1746.2006.04741.x.

    PMID: 17716344BACKGROUND

  • 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.

    PMID: 17122030BACKGROUND

  • Degenhardt BF, Kuchera ML. Update on osteopathic medical concepts and the lymphatic system. J Am Osteopath Assoc. 1996 Feb;96(2):97-100. doi: 10.7556/jaoa.1996.96.2.97.

    PMID: 8838905BACKGROUND

  • 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.

    PMID: 9558831BACKGROUND

  • 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.

    PMID: 21464262BACKGROUND

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

    PMID: 12197782BACKGROUND

  • 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. doi: 10.1002/ana.20315.

    PMID: 15546155BACKGROUND

  • 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.

    PMID: 1377192BACKGROUND

  • 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.

    PMID: 21660676BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • David Tegay, D.O.

    New York Institute of Technology College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

August 30, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

January 21, 2016

Record last verified: 2014-09

Locations

US(2)