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

NCT01636011 | Completed

• 1 other identifier: BHS-808
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Osteopathic Manipulative Medicine; Speech; Pulmonary Function

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function tests

  1 day

Study Arms (2)

OMM Treatment

EXPERIMENTAL

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

Other: Osteopathic Manipulative Medicine Treatment

Light Touch sham

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.

Other: Light Touch sham

Interventions

Osteopathic Manipulative Medicine Treatment OTHER

Osteopathic Manipulative Medicine Treatment

OMM Treatment

Light Touch sham OTHER

Light Touch sham

Light Touch sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT NYCOM Academic Health Care Center

Old Westbury, New York, 11568, United States

Location

Related Publications (10)

• 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.

  PMID: 8838905 BACKGROUND

• 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.

  PMID: 6725033 BACKGROUND

• 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.

  PMID: 8407387 BACKGROUND

• 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.

  PMID: 16255396 BACKGROUND

• 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.

  PMID: 10835931 BACKGROUND

• 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.

  PMID: 11422431 BACKGROUND

• 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.

  PMID: 11215597 BACKGROUND

• 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.

  PMID: 15372591 BACKGROUND

• 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.

  PMID: 20809811 BACKGROUND

• 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.

  PMID: 17596587 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior

Study Officials

• Sheldon Yao, DO

  NYIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

US (1)