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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02344485
• Other study ID #: BHS-1065
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: New York Institute of Technology
• Contact: Jayme Mancini, D.O.
• Phone: 516-686-1237
• Email: jmancini[@]nyit.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• OMM treatment
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

Locations

Country	Name	City	State
United States	New York Institute of Technology- Academic Health Care Center	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stool analysis	Subjects will have the option of submitting stool samples up to five times over the study period to see if there is a difference in the gut bacterial flora between the period with no OMT and the period with OMT	11 week period
Other	Mouth analysis	Subjects will have the option of submitting mouth samples (ie. cheek swabs) up to five times over the study period to see if there is a difference in the oral bacterial flora between the period with no OMT and the period with OMT	11 week period
Primary	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	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
Secondary	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
Secondary	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