Recruiting

Osteopathic Manipulative Medicine

Sponsor:

New York Institute of Technology

Code:

NCT02344485

Conditions

Parkinson's Disease

Constipation

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

OMM treatment

Study Details

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.

Conditions

Parkinson's Disease

Constipation

Study ID

NCT02344485

Start date

Jan 1, 2015

Status verified date

Nov, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Control

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

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

Primary outcome measure

  • Constipation Scoring System (Cleveland Criteria) [ Time Frame: 11 week period ]

Central Contacts and Locations

Central contacts

Jayme Mancini, D.O.

516-686-1237jmancini@nyit.edu

Locations

New York Institute of Technology- Academic Health Care Center

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Brian Harper, M.D.

516-686-1300bharper@nyit.edu

More Information

Sponsor

New York Institute of Technology

Last update posted

Nov 13, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2023-11-13.