OMM Treatment for Parkinson's Disease

Overseen By Sheldon Yao, D.O.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Irritable bowel syndrome, Pregnancy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jayme Mancini, D.O.

Principal Investigator

New York Institute of Technology- Academic Health Care Center

Eligibility Criteria

This trial is for individuals over 40 with Parkinson's disease who also suffer from constipation as defined by the Rome III criteria. It aims to help those looking for non-drug treatments.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

I am over 40 years old.

I have been medically diagnosed with constipation.

Exclusion Criteria

I have been diagnosed with irritable bowel syndrome.

My cancer is located in my digestive system, abdomen, or pelvis.

I have a diagnosed reason for my long-term constipation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Observation

Surveys and optional stool tests are performed without OMM treatment to obtain baseline data

4 weeks

4 visits (in-person)

Treatment

Participants receive OMM treatment once a week for 4 weeks along with surveys and optional stool microbial tests

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in constipation symptoms and bacterial flora after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• OMM treatment

Trial Overview The study tests Osteopathic Manipulative Medicine (OMM), a gentle manual treatment, to see if it reduces constipation in Parkinson's patients and possibly affects mouth and gut bacteria.

Participant Groups

Group I: OMM treatment Experimental Treatment 1 Intervention

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 II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+