This trial is active, not recruiting.

Condition parkinson's disease
Treatments osteopathic manipulative medicine treatment, light touch sham
Sponsor New York Institute of Technology
Start date February 2013
End date November 2015
Trial size 50 participants
Trial identifier NCT01636011, BHS-808


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
osteopathic manipulative medicine treatment
Osteopathic Manipulative Medicine Treatment
(Sham Comparator)
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.
light touch sham
Light Touch sham

Primary Outcomes

Pulmonary Function tests
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease
Principal investigator Sheldon Yao, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by New York Institute of Technology.