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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Constipation
• Intervention / Treatment: Procedure: OMM treatment

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
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jayme Mancini, D.O.; Phone Number: 516-686-1237; Email: jmancini@nyit.edu

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • Recruiting
      • New York Institute of Technology- Academic Health Care Center
      • Sub-Investigator: Sheldon Yao, D.O.
      • Sub-Investigator: To Shan Li, D.O.
      • Contact: Brian Harper, M.D.; Phone Number: 516-686-1300; Email: bharper@nyit.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Osteopathic manipulation; OMM (Osteopathic Manipulative Medicine); OMT (Osteopathic Manipulative Treatment)
No Intervention: Control; Subjects will continue with their routine care. No OMM will be performed during this study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	11 week period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	11 week period
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	11 week period
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	11 week period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool analysis	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	11 week period
Mouth analysis	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	11 week period

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Jayme Mancini, D.O., New York Institute of Technology- Academic Health Care Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Constipation
• Other Study ID Numbers: BHS-1065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No