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

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.

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