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OMM Treatment for Parkinson's Disease

N/A

Recruiting

Led By To Shan Li, D.O.

Research Sponsored by New York Institute of Technology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically diagnosed with Parkinson's disease

Be over 40 years old

Must not have

Medically diagnosed with irritable bowel syndrome

Cancer of the gastrointestinal tract, abdomen, or pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 week period

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether OMM can decrease constipation symptoms in people with PD, as well as optionally changing the bacterial flora of the mouth and gut.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

OMM is known to be safe with minimal risk of side effects. It involves hands-on techniques that may include stretching, gentle pressure, and resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease.

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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with irritable bowel syndrome.

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

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

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I have not been diagnosed with Parkinson's disease.

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I have a spinal cord abnormality or lesion.

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I have experienced unexplained weight loss, fever, night sweats, rectal bleeding, or black stools recently.

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I have not had abdominal or pelvic surgery in the last 6 weeks.

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I cannot or do not want to receive osteopathic manipulative treatment.

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I have an enlarged area in my lower aorta.

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I have active hepatitis, infectious mononucleosis, or an enlarged spleen.

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I do not have chronic constipation according to Rome III criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 week period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 week period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 week period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Constipation Scoring System (Cleveland Criteria)

Secondary study objectives

Bristol Stool Scale

PAC-QOL©

PAC-SYM©

Other study objectives

Mouth analysis

Stool analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OMM treatmentExperimental Treatment1 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: ControlActive Control1 Intervention

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

0 / 13Eligibility criteria met