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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 : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Tracking Information
First Submitted Date  ICMJE January 16, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date May 4, 2020
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2015)
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: January 22, 2015)
Stool analysis [ Time Frame: 11 week period ]
Subjects will have the option of submitting stool samples up to nine 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
 
Descriptive Information
Brief Title  ICMJE Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
Official Title  ICMJE Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Constipation
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: OMM treatment
  • No Intervention: Control
    Subjects will continue with their routine care. No OMM will be performed during this study period
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: To Shan Li, D.O. 516-686-3933 comomm1@nyit.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344485
Other Study ID Numbers  ICMJE BHS-1065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New York Institute of Technology
Study Sponsor  ICMJE New York Institute of Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: To Shan Li, D.O. New York Institute of Technology- Academic Health Care Center
PRS Account New York Institute of Technology
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP