Clinical trial NCT02344485: 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
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Constipation
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Constipation Scoring System (Cleveland Criteria)
timeFrame: 11 week period
Secondary outcomes:
measure: Bristol Stool Scale
timeFrame: 11 week period
measure: PAC-SYM©
timeFrame: 11 week period
measure: PAC-QOL©
timeFrame: 11 week period
Other outcomes:
measure: Stool analysis
timeFrame: 11 week period
measure: Mouth analysis
timeFrame: 11 week period
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology- Academic Health Care Center
state: New York
Study officials:
affiliation: New York Institute of Technology- Academic Health Care Center
name: Jayme Mancini, D.O.
role: PRINCIPAL_INVESTIGATOR
References: