Osteopathic Manipulative Medicine for Parkinson's Disease (NCT05884944)

Osteopathic Manipulative Medicine for Parkinson's Disease (NCT05884944)

Trial Overview

Osteopathic Manipulative Medicine for Parkinson's Disease (NCT05884944)

Trial Overview

| Field | Value |
|-------|-------|
| NCT Number | NCT05884944 |
| Status | RECRUITING |
| Phase | Not Applicable |
| Sponsor | New York Institute of Technology |
| Study Type | Interventional |
| Allocation | Randomized |
| Intervention | Osteopathic Manipulative Medicine (OMM) - Muscle Energy Technique |
| Conditions | Parkinson's Disease, Osteopathy in Diseases Classified Elsewhere |
| Enrollment | 20 participants (estimated) |
| Start Date | July 6, 2023 |
| Primary Completion | December 2025 (estimated) |

Principal Investigator

Sheldon Yao, DO — Chair, Professor, Department of Osteopathic Manipulative Medicine, New York Institute of Technology

Contact: syao@nyit.edu | (516) 686-1300

Location

NYIT College of Osteopathic Medicine, Old Westbury, New York, United States

Scientific Rationale

Parkinson's Disease and Mobility

Parkinsonism, most commonly caused by Parkinson's disease (PD), is characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit independence and community engagement for those with PD. Pain ranks among the most troublesome non-motor symptoms associated with PD, and rigidity is commonly associated with pain in patients with PD.

Osteopathic Medicine Approach

Osteopathic medicine treats somatic dysfunction — impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) aims to restore proper function by addressing these interconnected systems.

Theoretical Mechanisms:

Rationale for Lower Extremity Focus

Lower extremity dysfunction significantly impacts:

• Gait and balance
• Falls risk
• Independence in daily activities
• Quality of life

Study Design

Methodology

• Design: Randomized, parallel-group, single-blind interventional study
• Purpose: Treatment
• Masking: Single-blind (investigator masked)

Arms and Interventions

Experimental Group: OMM - Muscle Energy Technique

For the OMM treatment group, an osteopathic manipulative treatment protocol is 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:

• Hip: Adductor, extensor, and flexor muscles
• Knee: Extensors and flexors
• Ankle: Plantar and dorsiflexion muscles

Control Group: Sham - Light Touch

The sham group receives passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching the joint physiologic barrier. This mimics the OMM treatment duration and physical contact without providing the therapeutic intervention.

Based on Wells et al. (1999) sham procedure protocol.

Outcome Measures

Primary Outcomes (Pre and Post Intervention - 1 Hour)

| Measure | Instrument | Description |
|---------|------------|-------------|
| Mechanical Stress Relaxation Time | MyotonPro | [ms] |
| Dynamic Stiffness | MyotonPro | [N/m] |
| Step Cycle Time | Biodex Gait Trainer 3 | Cycles/second during 2-minute walk |
| Average Step Length | Biodex Gait Trainer 3 | [cm] during 2-minute walk |
| Step Symmetry | Biodex Gait Trainer 3 | Time on each foot [%] |
| Hip ROM (Flexion/Extension) | Goniometer | Degrees |
| Knee ROM (Flexion/Extension) | Goniometer | Degrees |
| Ankle ROM (Dorsiflexion/Plantarflexion) | Goniometer | Degrees |
| Timed Up & Go (TUG) | 3-meter walk | Seconds |

Secondary Outcomes (Pre and 1 Week Post Intervention)

| Measure | Instrument | Description |
|---------|------------|-------------|
| Lower Extremity Functional Scale (LEFS) | Questionnaire | Scale 9-80; higher = less disability |

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Parkinson's disease as per a neurologist
• Hoehn and Yahr (H-Y) Scale severity of 2-4
• Able to receive OMM
• Able to be in supine and prone position for MyotonPRO measurements
• Able to ambulate for gait measurements
• Have musculoskeletal complaints of leg pain/cramping or gait abnormalities due to PD

Exclusion Criteria

• Presence of severe fasciculations (interferes with measurements)
• Gait disorders not attributed to PD
• Presence of other neurological diagnoses affecting outcome measures (stroke, multiple sclerosis, etc.)

Demographic Requirements

• Sex: All
• Minimum Age: 18 years
• Healthy Volunteers: No

Therapeutic Implications

Potential Benefits of OMT in PD

If successful, this trial could demonstrate:

Clinical Translation

Positive results would support:

• Integration of OMT into multidisciplinary PD care teams
• Development of standardized OMT protocols for neurodegenerative diseases
• Combination approaches with standard PD pharmacotherapy
• Patient-accessible complementary therapy options

Comparison to Other Physical Therapies

This trial uses objective instrumentation (MyotonPro, Biodex Gait Trainer) to quantify changes, which is more rigorous than many physical therapy studies relying solely on clinical scales.

Cross-References to NeuroWiki Mechanisms

• [Parkinson's Disease](/diseases/parkinsons-disease) — Primary condition
• [Tremor and Rigidity in Parkinsonian Disorders](/mechanisms/tremor-mechanisms-parkinsonian) — Motor symptom target
• [Gait and Balance Disorders](/mechanisms/psp-gait-balance-disorders) — Functional outcome
• [Rigidity in Parkinson's Disease](/mechanisms/pd-rigidity) — Symptom target
• [Gait and Freezing in Parkinson's Disease](/mechanisms/pd-gait-freezing) — Functional outcome
• [Non-Motor Symptoms in Parkinson's Disease](/mechanisms/pd-non-motor-symptoms) — Pain component
• [Dopamine Signaling Pathway](/mechanisms/dopamine-signaling-pathway) — Underlying pathology
• [Physical Therapy for Parkinson's Disease](/therapeutics/physical-therapy-parkinsons) — Related intervention
• [Exercise and Physical Activity Neuroprotection](/therapeutics/exercise-physical-activity-neuroprotection) — Broader context
• [Complementary and Alternative Medicine in Neurodegeneration](/therapeutics/cam-neurodegeneration) — Integrative approaches

Related Pages

• [Physical Exercise in Parkinson's Disease](/therapeutics/physical-exercise-parkinsons) — Evidence-based exercise approaches
• [Physical Therapy and Rehabilitation](/therapeutics/physical-therapy-rehabilitation) — General rehabilitation
• [Osteopathic Medicine](/therapeutics/osteopathic-medicine) — OMT context
• [Complementary and Alternative Medicine in Neurodegeneration](/therapeutics/cam-neurodegeneration)

References

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