Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease - Full Text View

Purpose

The purpose of this study is to investigate the effect of selected Osteopathic Manipulative Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD) in comparison to light touch. Effectiveness will be measured through pulmonary function tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned to one of the two groups: OMM treatment group or light touch group. Although OMM treatment has been used on PD patients, a randomized controlled study has not been done to establish its effect on PD respiratory function. The authors believe that this study will show OMM's effectiveness.

Condition	Intervention
Parkinson's Disease	Other: Osteopathic Manipulative Medicine Treatment Other: Light Touch sham

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

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

Primary Outcome Measures:

Pulmonary Function tests [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	88
Study Start Date:	February 2013
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OMM Treatment In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.	Other: Osteopathic Manipulative Medicine Treatment Osteopathic Manipulative Medicine Treatment
Sham Comparator: Light Touch sham In this group the physician uses the dorsum of his hand to the same areas and for the same time that the OMM treatment arm receives.	Other: Light Touch sham Light Touch sham

Detailed Description:

Osteopathic Manipulative Medicine (OMM) on the thoracic cage and diaphragm is commonly used in clinical practice to address myofascial imbalances, including muscle spasms to improve thoracic cage excursion. Prior research has demonstrated that manual approaches applied to the thoracic cage have positive results with lung function and reducing inflammation.

Parkinson's disease (PD) is a common disabling and progressive neuro-degenerative disorder. Morbidity and mortality are frequently associated with pulmonary dysfunction in patients with PD. Pulmonary function tests (PFT) have been utilized to document respiratory impairment in PD patients. Researchers estimate that 89% of people with PD have speech and voice disorders including disorders of laryngeal, respiratory and articulatory function.

These authors hypothesize that performing OMM on the thoracic cage of PD subjects will show improvement in PFT, chest expansion, and speech production. Subjects with PD meeting the criteria for the study will be randomly assigned to either an OMM treatment or light touch control group. Each subject will be involved in one treatment visit. During this visit, the following will be measured before and after OMM or light touch procedures: maximal and minimal chest circumference; sound pressure, duration, and perceptual measures during sustained vowel phonation and Rainbow Reading; Forced Vital Capacity (FVC), Forced Expiratory Volume/1 second (FEV1), Peak Expiratory Flow (PEF), Forced Expiratory Flow 25%-75% (FEF25-75%), and Maximal Voluntary Ventilation (MVV). Data analysis will be performed with SPSS using Analysis of Covariance to measure significance.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Medically diagnosed with Parkinson's Disease
on a stable medication dose
over the age of 18

Exclusion Criteria:

no clinical diagnosis of Parkinson's Disease
inability to withhold Parkinson's Disease morning medication dose to perform the study
medication that might cause pulmonary dysfunction
inability to perform PFT because of anatomical abnormalities
clinical signs of dementia
pacemaker that interferes with pectoral traction
metastatic cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636011

Contacts

Contact: Sheldon Yao, DO

516-686-3754

syao@nyit.edu

Locations

United States, New York
NYIT NYCOM Academic Health Care Center	Recruiting
Old Westbury, New York, United States, 11568
Principal Investigator: Sheldon Yao, DO

Sponsors and Collaborators

New York Institute of Technology

Investigators

Principal Investigator:

Sheldon Yao, DO

NYIT

More Information

Publications:

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

Belcastro MR, Backes CR, Chila AG. Bronchiolitis: a pilot study of osteopathic manipulative treatment, bronchodilators, and other therapy. J Am Osteopath Assoc. 1984 May;83(9):672-6.

Sleszynski SL, Kelso AF. Comparison of thoracic manipulation with incentive spirometry in preventing postoperative atelectasis. J Am Osteopath Assoc. 1993 Aug;93(8):834-8, 843-5.

Sathyaprabha TN, Kapavarapu PK, Pall PK, Thennarasu K, Raju TR. Pulmonary functions in Parkinson's disease. Indian J Chest Dis Allied Sci. 2005 Oct-Dec;47(4):251-7.

Yamada H, Murahashi M, Takahashi H, Kai K, Shibuya S, Jimi T, Wakayama Y, Yamada M. [Respiratory function impairment in patients with Parkinson's disease--a consideration on the possible pathogenetic relation to autonomic dysfunction]. Rinsho Shinkeigaku. 2000 Feb;40(2):125-30. Japanese.

Polatli M, Akyol A, Cildag O, Bayülkem K. Pulmonary function tests in Parkinson's disease. Eur J Neurol. 2001 Jul;8(4):341-5.

Ramig LO, Sapir S, Fox C, Countryman S. Changes in vocal loudness following intensive voice treatment (LSVT) in individuals with Parkinson's disease: a comparison with untreated patients and normal age-matched controls. Mov Disord. 2001 Jan;16(1):79-83.

Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8.

Rapaport MH, Schettler P, Bresee C. A Preliminary Study of the Effects of a Single Session of Swedish Massage on Hypothalamic-Pituitary-Adrenal and Immune Function in Normal Individuals. J Altern Complement Med. 2010 Sep 1. [Epub ahead of print]

Bockenhauer SE, Chen H, Julliard KN, Weedon J. Measuring thoracic excursion: reliability of the cloth tape measure technique. J Am Osteopath Assoc. 2007 May;107(5):191-6.

Responsible Party:	New York Institute of Technology
ClinicalTrials.gov Identifier:	NCT01636011 History of Changes
Other Study ID Numbers:	BHS-808
Study First Received:	July 5, 2012
Last Updated:	April 28, 2013
Health Authority:	United States: Department of Health and Human Services United States: Institutional Review Board

Keywords provided by New York Institute of Technology:

Parkinson's Disease
Osteopathic Manipulative Medicine
Speech
Pulmonary Function

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013