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

Study Overview
=================
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.

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

Conditions
-----------------
Parkinson's Disease, Constipation

Intervention / Treatment
-----------------
* Procedure: OMM treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMM treatment<br>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<br>* 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<br>* Other names: Osteopathic manipulation;|
| No Intervention: Control<br>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 |