search
Back to results

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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Medicine Treatment
Light Touch sham
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's Disease, Osteopathic Manipulative Medicine, Speech, Pulmonary Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYIT NYCOM Academic Health Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OMM Treatment

Light Touch sham

Arm Description

In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.

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.

Outcomes

Primary Outcome Measures

Pulmonary Function tests

Secondary Outcome Measures

Full Information

First Posted
July 5, 2012
Last Updated
October 13, 2017
Sponsor
New York Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT01636011
Brief Title
Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease
Official Title
Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Osteopathic Manipulative Medicine, Speech, Pulmonary Function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMM Treatment
Arm Type
Experimental
Arm Description
In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
Arm Title
Light Touch sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Medicine Treatment
Intervention Description
Osteopathic Manipulative Medicine Treatment
Intervention Type
Other
Intervention Name(s)
Light Touch sham
Intervention Description
Light Touch sham
Primary Outcome Measure Information:
Title
Pulmonary Function tests
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Yao, DO
Organizational Affiliation
NYIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYIT NYCOM Academic Health Care Center
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8838905
Citation
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.
Results Reference
background
PubMed Identifier
6725033
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
8407387
Citation
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.
Results Reference
background
PubMed Identifier
16255396
Citation
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.
Results Reference
background
PubMed Identifier
10835931
Citation
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.
Results Reference
background
PubMed Identifier
11422431
Citation
Polatli M, Akyol A, Cildag O, Bayulkem K. Pulmonary function tests in Parkinson's disease. Eur J Neurol. 2001 Jul;8(4):341-5. doi: 10.1046/j.1468-1331.2001.00253.x.
Results Reference
background
PubMed Identifier
11215597
Citation
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. doi: 10.1002/1531-8257(200101)16:13.0.co;2-h.
Results Reference
background
PubMed Identifier
15372591
Citation
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. doi: 10.1002/mds.20213.
Results Reference
background
PubMed Identifier
20809811
Citation
Rapaport MH, Schettler P, Breese 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 Oct;16(10):1079-88. doi: 10.1089/acm.2009.0634.
Results Reference
background
PubMed Identifier
17596587
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs