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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Osteopathic Manipulative Medicine (OMM), a hands-on treatment by specially trained doctors, might reduce constipation in people with Parkinson's disease. Researchers aim to determine if OMM affects bacteria in the mouth and gut. Participants will receive OMM treatment in the trial's second half. Individuals with both Parkinson's disease and constipation may be suitable for this study. As an unphased trial, it offers a unique opportunity to explore potential benefits of OMM for Parkinson's-related constipation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that OMM treatment is safe for people with Parkinson's disease?

Research shows that Osteopathic Manipulative Medicine (OMM) is a safe and gentle treatment. Studies have found that most side effects from OMM are mild. Patients often express satisfaction with the treatment and rarely encounter serious side effects. For example, patients with conditions like ALS reported no negative effects after receiving OMM. Overall, OMM is considered safe and well-tolerated for various conditions, including Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OMM (Osteopathic Manipulative Medicine) treatment for Parkinson's disease because it offers a hands-on approach to alleviate constipation, a common issue in Parkinson's patients. Unlike traditional medications that often focus on brain chemistry, this treatment uses manual manipulation techniques to potentially improve gut function and patient comfort. By integrating OMM with routine care, there's hope for a more holistic management of Parkinson's symptoms, addressing both motor and non-motor challenges.

What evidence suggests that OMM treatment might be an effective treatment for constipation in Parkinson's disease?

Research has shown that Osteopathic Manipulative Medicine (OMM) might help people with Parkinson's disease. Studies have found that OMM can improve movement and reduce some symptoms of Parkinson's. For example, some patients experienced better movement and balance after receiving OMM. Another study reported significant improvements in scores related to Parkinson's symptoms after treatment. While these studies mainly focus on movement, they also suggest possible benefits for other symptoms, like constipation. In this trial, participants in the experimental arm will receive OMM treatment specifically for constipation in Parkinson's disease, while those in the control arm will continue with their routine care without OMM. OMM uses gentle hands-on techniques, making it a promising option for those seeking additional treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Jayme Mancini, D.O.

Principal Investigator

New York Institute of Technology- Academic Health Care Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02107638

Effect of Osteopathic Manipulative Medicine on Parkinson ... OMM is a gentle hand-on manual therapy. The research team created a protocol coined "PARK-OMM" protocol. These techniques aim to help treat myofascial ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34547197/

Efficacy of osteopathic manipulative treatment in patients ... OMT has demonstrated the greatest efficacy on managing motor-related and neurologic symptoms and assists in treating the greater prevalence of somatic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9750800/

Preliminary Effects of Osteopathic Manipulative Medicine ... OMT has been shown to benefit individuals with PD as well as other older individuals suffering from postural and balance issues as well as ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877573X13000154

An evidence-based osteopathic approach to Parkinson ... OMT can be particularly helpful in treating patients with PD when supporting functional gains or minimizing decline over time. Considering the promising results ...

5. cureus.com cureus.com/articles/402906-application-of-osteopathic-manipulative-treatment-omt-in-neurodegenerative-disorders-a-scoping-review

Application of Osteopathic Manipulative Treatment (OMT) ... Statistically significant improvements in UPDRS scores post OMM treatment (p=0.021). Clinically significant improvements in motor function and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642050/

Defining the landscape of patient harm after osteopathic ... The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05884944

Effects Of Osteopathic Manipulative Medicine(OMM) On ... Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.