Osteopathic Manipulative Medicine for Parkinson's Disease (NCT05884944)
Trial Overview
Mermaid diagram (expand to render)
| 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:
Myofascial Release: OMT may release tension in muscles and fascia, reducing rigidity
Joint Mobility Improvement: Manual techniques can improve range of motion in affected joints
Neuromuscular Re-education: May help reset abnormal muscle tone patterns
Autonomic Regulation: OMT may influence autonomic function affecting muscle tone
Pain Reduction: By addressing somatic dysfunction, OMT may reduce pain associated with rigidityRationale for Lower Extremity Focus
Lower extremity dysfunction significantly impacts:
- Gait and balance
- Falls risk
- Independence in daily activities
- Quality of life
The trial focuses on hip, knee, and ankle joints bilaterally, targeting muscles that are critical for mobility and posture.
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
Muscle energy technique is a direct active treatment where the subject moves their joint in a direction against a counterforce by the treatment provider for 3 seconds, repeated 3 times, followed by a passive stretch applied by the provider.
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:
Reduced Muscle Stiffness: Objective measurement via MyotonPro
Improved Gait Parameters: Step length, symmetry, cycle time
Enhanced Range of Motion: Hip, knee, ankle mobility
Better Functional Outcomes: Improved TUG and LEFS scores
Non-Pharmacological Option: Complementary to dopaminergic medicationsClinical 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
[ClinicalTrials.gov - NCT05884944](https://clinicaltrials.gov/study/NCT05884944)bfe67bb53c3c532ef4237fa3323691ae27404769