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

NCT ID: NCT02344485

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Parkinson's Disease; Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMM treatment

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

Group Type: EXPERIMENTAL

OMM treatment

Intervention Type: PROCEDURE

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

Control

Subjects will continue with their routine care. No OMM will be performed during this study period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

OMM (Osteopathic Manipulative Medicine); OMT (Osteopathic Manipulative Treatment); Osteopathic manipulation

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayme Mancini, D.O.

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology- Academic Health Care Center

Locations

New York Institute of Technology- Academic Health Care Center

Old Westbury, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jayme Mancini, D.O.

Role: CONTACT

jmancini@nyit.edu

516-686-1237

Facility Contacts

Brian Harper, M.D.

Role: primary

bharper@nyit.edu

516-686-1300

Other Identifiers

BHS-1065

Identifier Type: -

Identifier Source: org_study_id