OMM for Parkinson's Disease

Overseen By Sheldon Yao, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Severe fasciculations, Stroke, Multiple sclerosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Osteopathic Manipulative Medicine (OMM) affects muscle stiffness, range of motion, and walking in people with Parkinson's disease. Researchers will divide participants into two groups: one will receive real OMM treatments focused on the legs, while the other will undergo a light-touch procedure that doesn't target muscle barriers. This trial is ideal for individuals diagnosed with Parkinson’s who experience leg pain or walking difficulties. Participants will attend one session in New York and complete a follow-up survey by phone. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of OMM for Parkinson’s symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical assessments and treatments, so you may not need to change your medication routine.

What prior data suggests that Osteopathic Manipulative Medicine is safe for Parkinson's Disease patients?

Research shows that Osteopathic Manipulative Medicine (OMM) is generally well-tolerated for conditions like Parkinson's Disease. Studies have found that OMM can help manage symptoms such as muscle stiffness and joint movement issues. This treatment uses hands-on techniques to improve muscle and joint function.

Researchers have identified and categorized any side effects of OMM, allowing for safety comparisons across different studies. While no treatment is completely without risk, OMM is usually considered safe, with no severe side effects commonly reported. This suggests that, for most people, it is a low-risk option.

OMM is a non-drug therapy, avoiding many side effects associated with medications. For those considering joining a trial for OMM, the existing safety data is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Osteopathic Manipulative Medicine (OMM) for Parkinson's disease because it offers a non-drug approach that focuses on improving physical function through manual techniques. Unlike typical treatments involving medications like levodopa that mainly aim to manage symptoms, OMM uses muscle energy techniques to enhance mobility and flexibility in the lower extremities by specifically targeting muscles around the hip, knee, and ankle. This hands-on method can potentially complement existing therapies, offering a holistic approach that directly addresses physical limitations associated with Parkinson's.

What evidence suggests that Osteopathic Manipulative Medicine is effective for Parkinson's Disease?

This trial will compare Osteopathic Manipulative Medicine (OMM) with a sham treatment. Studies have shown that OMM can help manage symptoms related to movement and nerve conditions. OMM reduces muscle spasms and improves joint mobility. Research suggests it may aid walking by enhancing blood flow to nerves. Although some studies haven't found significant changes in certain body indicators, study limitations might explain this. Overall, OMM is considered a promising method for managing symptoms of long-term conditions like Parkinson's Disease. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients who can walk and have leg pain or gait issues because of their condition. They should be at a moderate stage (2-4 on the H-Y Scale) and able to lie down for tests. People with severe muscle twitching, non-PD related walking problems, or other neurological conditions like stroke or MS cannot join.

Inclusion Criteria

I can walk on my own for tests.

I have Parkinson's disease with a moderate severity level.

I experience leg pain, cramping, or walking difficulties due to Parkinson's disease.

Exclusion Criteria

My walking difficulties are not caused by Parkinson's disease.

I have severe muscle twitches that affect tests.

I do not have neurological conditions like stroke or multiple sclerosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Osteopathic Manipulative Treatment (OMT) or a sham control procedure to the lower extremities, with assessments of muscle stiffness, range of motion, and gait.

1 day

1 visit (in-person)

Follow-up

Participants complete a brief survey over the phone to assess outcomes one week after the treatment session.

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Medicine
• Sham- Light touch, not reaching restrictive barrier

Trial Overview The study compares Osteopathic Manipulative Medicine (OMM), which involves hands-on techniques to improve muscle function, against a sham treatment that mimics OMM without active intervention. Muscle stiffness, walking ability, and joint movement are measured before and after sessions.

How Is the Trial Designed?

Group I: Interventional Group- OMM- Muscle energy Experimental Treatment 1 Intervention

For the OMM treatment group, an osteopathic manipulative treatment protocol will be applied to the lower extremities, specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated

Group II: Control Group- Sham- Light touch, not reaching restrictive barrier Placebo Group 1 Intervention

Joint articulation without engaging joint barriers The sham group will serve as the control group and will receive a sham-control procedure as outlined in the paper by Wells, et al in which they will undergo voluntary ROM and then passive movement with the same joint movements without reaching their barrier and no isometric contraction (Wells et al. 1999) The proposed sham procedure will occupy the same amount of time as MET treatment.

Osteopathic Manipulative Medicine is already approved in United States for the following indications:

Approved in United States as Osteopathic Manipulative Medicine for:

• Chronic Lower Back Pain
• Musculoskeletal Causes of Back Pain

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Published Research Related to This Trial

A single session of osteopathic manipulative treatment (OMT) significantly improved gait parameters such as stride length, cadence, and maximum velocities in 10 patients with Parkinson's disease, indicating its potential efficacy in managing motor deficits.

In contrast, the sham-control group showed no significant changes, highlighting that the improvements in the treated group were likely due to the OMT rather than placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. Wells, MR., Giantinoto, S., D'Agate, D., et al.[2019]

In a randomized controlled trial involving 11 participants with Parkinson's disease, bi-weekly Osteopathic Manipulative Medicine (OMM) treatments for 6 weeks led to significant improvements in motor function as measured by the MDS-UPDRS scale.

While there were no significant changes in balance as assessed by the Mini-BESTest and Sensory Organization Test, the study suggests that OMM may still be a useful complementary therapy for enhancing motor function in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manipulation as a complementary approach to Parkinson's disease: A controlled pilot study. DiFrancisco-Donoghue, J., Apoznanski, T., de Vries, K., et al.[2018]

Osteopathic manipulative treatment (OMT) has shown significant efficacy in managing motor-related and neurological symptoms in patients with Parkinson's disease, which is crucial for maintaining their quality of life.

Despite the promising results, research on OMT for Parkinson's disease is still limited, highlighting the need for further studies to explore its full potential and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of osteopathic manipulative treatment in patients with Parkinson's disease: a narrative review. Li, R., Jose, A., Poon, J., et al.[2022]

Osteopathic manipulative treatment (OMT) is a hands-on therapy that may help improve physical wellness in patients with neurological disorders like Parkinson's disease and multiple sclerosis, addressing symptoms such as motor issues, fatigue, and chronic pain.

While OMT is considered a safe adjunct treatment, there is still a need for more research to fully understand its efficacy in neurorehabilitation, highlighting the importance of further studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back to the Future: An Appraisal of the Role of Osteopathic Manipulative Treatment in Patients with Neurological Diseases. Bonanno, M., Calabrò, RS.[2023]

Patients with Parkinson's disease exhibited significantly higher frequencies of specific cranial strain patterns, such as bilateral occipitoatlantal compression (87% vs. 50%) and bilateral occipitomastoid compression (40% vs. 10%), compared to age-matched normal controls.

Osteopathic manipulative treatment effectively reduced the frequency of these cranial strain patterns in Parkinson's patients over subsequent visits, bringing them down to levels similar to those found in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of cranial strain patterns in patients with idiopathic Parkinson's disease. Rivera-Martinez, S., Wells, MR., Capobianco, JD.[2013]

In a UK Parkinson's disease clinic study involving 80 patients, 54% reported using at least one form of complementary therapy or non-prescribed medication, with 38.7% using it specifically for Parkinson's disease.

The most popular complementary therapies among patients were massage and aromatherapy, and younger patients at diagnosis were more likely to use these therapies, indicating a potential trend in seeking alternative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of complementary therapies and non-prescribed medication in patients with Parkinson's disease. Ferry, P., Johnson, M., Wallis, P.[2019]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02107638

Effect of Osteopathic Manipulative Medicine on Parkinson ... This form of treatment aims to help decrease muscle spasms and improve joint range of motion and movement. We are proposing a pilot study to investigate the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844025019516

The role of osteopathic manipulative treatment in ... Osteopathic manipulative treatment (OMT) should be considered a promising holistic treatment to manage better pain and symptoms related to the chronic stages ...

4. osteopathic.org osteopathic.org/2022/05/07/effects-of-osteopathic-manipulative-treatment-vs-osteopathic-cranial-manipulative-medicine-on-parkinsonian-gait/

Effects of osteopathic manipulative treatment vs. ... Osteopathic cranial manipulative medicine (OCMM) can improve gait performance by improving circulation to the affected nervous tissue.

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

Preliminary Effects of Osteopathic Manipulative Medicine ... OMT used in this study did not significantly affect the chosen oxidative stress biomarkers, however many limitations of the study may have impeded possible ...

6. cureus.com cureus.com/articles/402906-application-of-osteopathic-manipulative-treatment-omt-in-neurodegenerative-disorders-a-scoping-review.pdf?email=

Application of Osteopathic Manipulative Treatment (OMT) ... An additional non-pharmacologic therapy being investigated to manage neurodegenerative diseases is osteopathic manipulative treatment (OMT).

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

Defining the landscape of patient harm after osteopathic ... This work conceptualized a model for identifying and grading post-OMT AEs, which should facilitate future comparisons between institutions.