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

Primary Purpose

Parkinson's Disease, Constipation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OMM treatment
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

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

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

Sites / Locations

  • New York Institute of Technology- Academic Health Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OMM treatment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Constipation Scoring System (Cleveland Criteria)
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

Bristol Stool Scale
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©
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©
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

Full Information

First Posted
January 16, 2015
Last Updated
November 3, 2021
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02344485
Brief Title
Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
Official Title
Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMM treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will continue with their routine care. No OMM will be performed during this study period
Intervention Type
Procedure
Intervention Name(s)
OMM treatment
Other Intervention Name(s)
OMM (Osteopathic Manipulative Medicine), OMT (Osteopathic Manipulative Treatment), Osteopathic manipulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Constipation Scoring System (Cleveland Criteria)
Description
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
Time Frame
11 week period
Secondary Outcome Measure Information:
Title
Bristol Stool Scale
Description
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
Time Frame
11 week period
Title
PAC-SYM©
Description
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
Time Frame
11 week period
Title
PAC-QOL©
Description
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
Time Frame
11 week period
Other Pre-specified Outcome Measures:
Title
Stool analysis
Description
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
Time Frame
11 week period
Title
Mouth analysis
Description
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
Time Frame
11 week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayme Mancini, D.O.
Phone
516-686-1237
Email
jmancini@nyit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayme Mancini, D.O.
Organizational Affiliation
New York Institute of Technology- Academic Health Care Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology- Academic Health Care Center
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Harper, M.D.
Phone
516-686-1300
Email
bharper@nyit.edu
First Name & Middle Initial & Last Name & Degree
Sheldon Yao, D.O.
First Name & Middle Initial & Last Name & Degree
To Shan Li, D.O.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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