Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT01636011 |
Recruitment Status :
Completed
First Posted : July 10, 2012
Last Update Posted : October 16, 2017
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease | Other: Osteopathic Manipulative Medicine Treatment Other: Light Touch sham | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease |
Actual Study Start Date : | February 2013 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
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Experimental: OMM Treatment
In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
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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.
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Other: Light Touch sham
Light Touch sham |
- Pulmonary Function tests [ Time Frame: 1 day ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- - 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636011
United States, New York | |
NYIT NYCOM Academic Health Care Center | |
Old Westbury, New York, United States, 11568 |
Principal Investigator: | Sheldon Yao, DO | NYIT |
Responsible Party: | New York Institute of Technology |
ClinicalTrials.gov Identifier: | NCT01636011 |
Other Study ID Numbers: |
BHS-808 |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | October 16, 2017 |
Last Verified: | October 2017 |
Parkinson's Disease Osteopathic Manipulative Medicine Speech Pulmonary Function |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |