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?

The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured. Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Participants will be randomly assigned to a control or experimental group. After a visit with the treating physician, both groups will have muscle stiffness tested using a myotonometry meter via a MyotonPRO device, gait measured while walking on a treadmill for 2 minutes before and after treatment, and range of motion tested using a goniometer. One week after the visit, participants will be asked to complete a brief survey over the phone with one of the study investigators.

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.

Is Osteopathic Manipulative Medicine (OMM) safe for humans?

Osteopathic Manipulative Medicine (OMM) is generally considered safe for humans, as it is a hands-on therapy used to treat various conditions, including neurological disorders like Parkinson's disease. While there are still questions about its effectiveness, it is suggested as a safe complementary treatment to promote physical wellness. ^{1 2 3 4 5}

How is Osteopathic Manipulative Medicine (OMM) different from other treatments for Parkinson's disease?

Osteopathic Manipulative Medicine (OMM) is a hands-on treatment that focuses on improving body function and balance by addressing somatic dysfunctions (issues with muscles and tissues). Unlike standard drug treatments for Parkinson's disease, which often focus on managing symptoms through medication, OMM uses manual techniques to enhance physical wellness and improve movement, such as gait and balance, in patients. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Osteopathic Manipulative Medicine (OMM) for Parkinson's Disease?

Research indicates that Osteopathic Manipulative Medicine (OMM) can improve balance and gait (the way someone walks) in people with Parkinson's Disease, suggesting it may help manage movement difficulties associated with the condition. ^{1 2 3 4 6}

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 receive oral medication.

I can lie on my back and stomach comfortably.

I can walk on my own for tests.

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

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]

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]

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]

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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Osteopathic manipulation as a complementary approach to Parkinson's disease: A controlled pilot study. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of osteopathic manipulative treatment in patients with Parkinson's disease: a narrative review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A retrospective study of cranial strain patterns in patients with idiopathic Parkinson's disease. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Use of complementary therapies and non-prescribed medication in patients with Parkinson's disease. [2019]