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

Parkinson's Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT02344485
• Study type: Interventional
• Source: New York Institute of Technology
• Contact: Jayme Mancini, D.O.
• Phone: 516-686-1237
• Email: jmancini@nyit.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2015
• Completion date: December 31, 2024