Osteopathic treatment for constipation in Parkinson's disease
Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
This study is testing if osteopathic treatment can help people with Parkinson's disease who are struggling with constipation feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | New York Institute of Technology Academic / other |
| Locations | 1 site (Old Westbury, New York) |
| Trial ID | NCT02344485 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of Osteopathic Manipulative Medicine (OMM) on alleviating constipation symptoms in individuals diagnosed with Parkinson's disease. Participants will undergo OMM treatment during the second half of an eleven-week trial, with assessments of constipation severity and quality of life conducted throughout the study. Additionally, optional stool samples will be collected to analyze changes in gut and oral bacterial flora. The study aims to provide insights into the efficacy of OMM in managing constipation associated with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with a medical diagnosis of Parkinson's disease and constipation.
Not a fit: Patients with other diagnosed causes of chronic constipation or additional neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for managing constipation in patients with Parkinson's disease.
How similar studies have performed: Previous studies have shown positive outcomes of OMM in improving constipation symptoms in other populations, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Old Westbury, New York
- New York Institute of Technology- Academic Health Care Center — Old Westbury, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jayme Mancini, D.O. — New York Institute of Technology- Academic Health Care Center
- Study coordinator: Jayme Mancini, D.O.
- Email: jmancini@nyit.edu
- Phone: 516-686-1237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.