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Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02344485
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief Summary:
The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. OMM is a safe and gentle manual treatment provided by osteopathic physicians. All participants will receive OMM during the second half of the eleven week trial.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Constipation Procedure: OMM treatment Not Applicable

Detailed Description:

PD is a progressive neurodegenerative disorder which includes motor and non-motor (autonomic) symptoms, such as constipation. OMM has been shown to improve constipation symptoms in non-diseased subjects and cerebral palsy subjects. Constipation will be measured before, during, and after treatment by a constipation scoring system (Cleveland Criteria) to measure the severity of constipation and by the Bristol Stool Scale to measure colonic transit time. The study subjects' assessment of their constipation symptoms (PAC-SYM) and quality of life (PAC-QOL) will also be measured throughout the study.

Studies have also shown that there is a difference in the gut and oral bacterial flora of constipated versus healthy adults, so subjects will be given the option to provide weekly stool samples for analysis to track bacterial colonies and to observe for any flora changes over the study period. This will provide data to determine if bacterial colonies in stool are altered by OMM.

The study will require ten weekly on-site visits over the course of eleven weeks. For the first half of the study, surveys and optional stool tests will be performed without OMM treatment for four weeks to obtain baseline data. For the second half of the study, all subjects will receive OMM for four weeks along with surveys and optional stool microbial tests to obtain the experimental data.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
Study Start Date : January 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OMM treatment
Subject will receive osteopathic manipulative treatment protocol for constipation in Parkinson's disease once a week for 4 weeks, in addition to continuing with their routine care
Procedure: OMM treatment
OMM is a gentle hands-on treatment that helps to reduce myofascial restrictions and improve joint range of motion. In doing so, it can address the mechanical, neurologic, and respiratory functions of the body
Other Names:
  • OMM (Osteopathic Manipulative Medicine)
  • OMT (Osteopathic Manipulative Treatment)
  • Osteopathic manipulation

No Intervention: Control
Subjects will continue with their routine care. No OMM will be performed during this study period



Primary Outcome Measures :
  1. Constipation Scoring System (Cleveland Criteria) [ Time Frame: 11 week period ]
    A standardized form measuring bowel movement patterns will be completed by the subject five times over the study period to see if there is a difference in constipation severity between the period with no OMT and the period with OMT


Secondary Outcome Measures :
  1. Bristol Stool Scale [ Time Frame: 11 week period ]
    A visual standardized stool chart will be used by the subject and study investigator nine times over the study period to visually categorize the shape of the stools to see if there is a difference in colonic transit time between the period with no OMT and the period with OMT

  2. PAC-SYM© [ Time Frame: 11 week period ]
    A standardized form will be completed by the subject five times over the study period to assess constipation symptoms to see if there is a difference between the period with no OMT and the period with OMT

  3. PAC-QOL© [ Time Frame: 11 week period ]
    A standardized form will be completed by the subject five times over the study period to assess the impact of constipation on daily life to see if there is a difference between the period with no OMT and the period with OMT


Other Outcome Measures:
  1. Stool analysis [ Time Frame: 11 week period ]
    Subjects will have the option of submitting stool samples up to five times over the study period to see if there is a difference in the gut bacterial flora between the period with no OMT and the period with OMT

  2. Mouth analysis [ Time Frame: 11 week period ]
    Subjects will have the option of submitting mouth samples (ie. cheek swabs) up to five times over the study period to see if there is a difference in the oral bacterial flora between the period with no OMT and the period with OMT



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically diagnosed with Parkinson's disease
  • Medically diagnosed with constipation (according to Rome III criteria)
  • Be over 40 years old

Exclusion Criteria:

  • No diagnosis of Parkinson's disease
  • No diagnosis of constipation that satisfies Rome III criteria
  • Medically diagnosed with irritable bowel syndrome
  • Another diagnosed cause for chronic constipation
  • Currently pregnant
  • Have another diagnosed neurologic condition (excluding headache or migraine, headache, migraine, dysautonomia, depression or other mood disorders (unless severe or uncontrolled), dementia or cognitive changes (unless severe), diffuse lewy body dementia, REM sleep behavior disorder, normal pressure hydrocephalus, multiple system atrophy P and C types, progressive supranuclear palsy, vascular parkinsonism, corticobasal ganglionic degeneration, and drug induced parkinsonism)
  • Spinal cord abnormality or lesion
  • Cancer of the gastrointestinal tract, abdomen, or pelvis
  • Anemia that has not been evaluated
  • Unexplained weight loss, fever, night sweats, rectal bleeding, or black stools in past 2 months
  • Active hepatitis, infectious mononucleosis, or enlarged spleen
  • Abdominal aortic aneurysm
  • Congenital malformation of the gastrointestinal tract
  • Abdominal or pelvic surgery within the past 6 weeks
  • Unable or unwilling to receive OMT.
  • Unable or unwilling to rate one's own stools using a visual chart or to bring a picture of one's stool to each visit

Information from the National Library of Medicine

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): NCT02344485


Contacts
Contact: To Shan Li, D.O. 516-686-3933 comomm1@nyit.edu

Locations
United States, New York
New York Institute of Technology- Academic Health Care Center Recruiting
Old Westbury, New York, United States, 11568
Contact: Brian Harper, M.D.    516-686-1300    bharper@nyit.edu   
Sub-Investigator: Sheldon Yao, D.O.         
Sub-Investigator: Jayme Mancini, D.O.         
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: To Shan Li, D.O. New York Institute of Technology- Academic Health Care Center

Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT02344485     History of Changes
Other Study ID Numbers: BHS-1065
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms