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

• ClinicalTrials.gov Identifier: NCT01636011
• Recruitment Status: Completed
• First Posted: July 10, 2012
• Last Update Posted: October 16, 2017
• Sponsor: New York Institute of Technology
• Information provided by (Responsible Party): New York Institute of Technology

Tracking Information

• First Submitted Date: July 5, 2012
• First Posted Date: July 10, 2012
• Last Update Posted Date: October 16, 2017
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 9, 2012): Pulmonary Function tests [ Time Frame: 1 day ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Parkinson's Disease

Intervention

• Other: Osteopathic Manipulative Medicine Treatment
  Osteopathic Manipulative Medicine Treatment
• Other: Light Touch sham
  Light Touch sham

Study Arms

• Experimental: OMM Treatment
  In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
  Intervention: Other: 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.
  Intervention: Other: Light Touch sham

Publications *

• 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.
• 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.
• 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, 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 19, 2016): 50
• Original Estimated Enrollment (submitted: July 9, 2012): 88
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01636011
• Other Study ID Numbers: BHS-808
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: New York Institute of Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: New York Institute of Technology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sheldon Yao, DO; NYIT

• PRS Account: New York Institute of Technology
• Verification Date: October 2017