- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107638
Effect of Osteopathic Manipulative Medicine on Parkinson Disease
Effect of Osteopathic Manipulative Medicine on Motor Function, Balance, and Neuroprotective Serum Markers in Parkinson Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Annually, 60,000 people within the United States are diagnosed with PD.1 The cardinal features of PD include resting tremor, rigidity, asymmetric onset, and bradykinesia.2 These characteristics appear to affect balance. Balance is a complex system that involves maintaining posture, facilitating movement, and recovering equilibrium to control one's body within its limits of stability. Balance involves the coordination of vestibular, visual, auditory, motor, and high level premotor systems, many of which are compromised in PD.3 Previous research found that 46% of the PD subjects fell within a three month period, and that 21% of subjects had their first fall during the three month period.4 Postural instability is a hallmark sign of PD that compromises balance control and increases the risk of falling.5,6
Many falls in PD occur because of postural instability and their inability to organize sensory information. The SOT identifies abnormalities in postural control, somatosensory, visual, and vestibular sensory systems. It offers a composite score that is a percentage based on normal age controls. We recently presented an abstract at the World Parkinson's Conference in Montreal, Canada that showed individual's with PD (n=20) who were categorized as fallers, scored lower on the SOT than non-fallers with PD.7
The pathogenesis of PD is a progressive neurologic depletion of dopaminergic neurons from the basal ganglia which manifests as common motor or extrapyramidal signs: tremor, bradykinesia, and rigidity. As the severity of PD progresses there is frequently postural instability and further disability. There have been relatively few studies investigating the effect of OMM on PD patients. One previous research study demonstrated that a single session of osteopathic manipulative medicine protocol on 10 PD subjects improved gait compared to age-matched sham-controls, particularly stride length, cadence, and maximum velocities of upper and lower extremities.8 Other studies on non-PD subjects have shown that OMM can improve subject balance. In a pilot study 20 elderly subjects with OMM protocol applied weekly for four weeks showed an improvement in postural instability, as measured by changes in anterior-posterior and medial-lateral sway on force plate observations.9 OMM has also been shown to improve subjects with dizziness. The outcomes were measured using the SMART Balance Master©. It was found that the composite score on the SMART Balance Master© significantly improved immediately after intervention as well as one week later. (P<.001)10
OMM utilized in improving gait in PD patients addressed muscle hypertonicity and joint motion restrictions by using muscle energy and articulatory techniques for the spine and the extremities.8 OMM techniques that were used to address balance focused on removing muscle spasms and restrictions of the spine and cranium. Based on our experience of treating PD patients in our clinical practice and the improvement of symptoms in the forementioned studies we developed a PARK-OMM protocol to utilize in this study. The protocol starts with a CV4 technique, which helps to address cranial restrictions, and can potentially affect patient's autonomic function.11,12 The protocol then proceeds to address each major spinal region and the extremities by decreasing muscle hypertonicity and increasing joint range of motion with direct OMM articulatory and muscle energy techniques. These techniques were selected due to their document efficacy in improving joint mobility in the general population as well as in PD both in clinical practice and documented prior studies.13
Hypothesis: OMM treatments twice a week over a 6-week period on PD subjects using a defined OMM protocol will produce a prolonged improvement in motor function measured by the Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and balance measured by the NeurCom SMART Balance Master© Sensory Organization Test (SOT) leading to a reduced number of falls. We are also going to screen for serum biomarker changes to investigate the potential effects of OMM. We expect that the OMM cohort will have significantly improved motor function scores, balance, and an associated decrease in falls. This would help to establish the role of OMM in the treatment of PD. Positive findings may also lead to additional studies investigating how OMM impacts the quality of life in PD patients. It could also promote further investigation on the potential mechanisms of OMM amongst the PD population.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568
- New York Institute of Technology - Academic Health Care Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medically diagnosed with Parkinson's Disease
- Over the age of 40
Exclusion Criteria:
- no clinical diagnosis of Parkinson's Disease
- having other diagnosed neurological diseases or disorders
- being completely wheelchair bound or having physical deformities that would prevent completion of the assessment tools
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OMM treatment arm
Subject will receive osteopathic manipulative treatment protocol for Parkinson's disease (PARK-OMM), twice a week for 6 weeks.
|
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 restrictions and improve joint range of motion.
Other Names:
|
Active Comparator: Counseling
Subjects will receive counseling sessions weekly to match the face to face time with a physician during the OMM treatment arm.
No OMM will be performed during this 6 week counseling study period.
|
Patients will be counseled on Parkinson's Disease related issues including prevention of falls, medications, diet, nutrition, exercise, tai-chi, yoga, meditation, and mental health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of falls
Time Frame: 10 week period
|
A fall log will be kept for subjects enrolled to see if there is a difference between those treated the OMM protocol or those who do not
|
10 week period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: 10 weeks
|
Balance will be measured via SOT measurements
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor function
Time Frame: 10-weeks
|
Motor function will be assessed via UPDRS scores
|
10-weeks
|
Serum biomarkers
Time Frame: 6 weeks
|
Blood draws at week 1, 3, 6 to compare changes in serum biomarkers
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheldon Yao, DO, NYIT College of Osteopathic Medicine
Publications and helpful links
General Publications
- Wells MR, Giantinoto S, D'Agate D, Areman RD, Fazzini EA, Dowling D, Bosak A. Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. J Am Osteopath Assoc. 1999 Feb;99(2):92-8. doi: 10.7556/jaoa.1999.99.2.92.
- Lopez D, King HH, Knebl JA, Kosmopoulos V, Collins D, Patterson RM. Effects of comprehensive osteopathic manipulative treatment on balance in elderly patients: a pilot study. J Am Osteopath Assoc. 2011 Jun;111(6):382-8. doi: 10.7556/jaoa.2011.111.6.382.
- Fraix M, Gordon A, Graham V, Hurwitz E, Seffinger MA. Use of the SMART Balance Master to quantify the effects of osteopathic manipulative treatment in patients with dizziness. J Am Osteopath Assoc. 2013 May;113(5):394-403.
- DiFrancisco-Donoghue J, Apoznanski T, de Vries K, Jung MK, Mancini J, Yao S. Osteopathic manipulation as a complementary approach to Parkinson's disease: A controlled pilot study. NeuroRehabilitation. 2017;40(1):145-151. doi: 10.3233/NRE-161400.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-975
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on OMM treatment arm
-
New York Institute of TechnologyRecruitingParkinson's Disease | ConstipationUnited States
-
Western University of Health SciencesCompletedLabyrinthitis | Vertigo | Benign Paroxysmal Positional Vertigo | DizzinessUnited States
-
A.T. Still University of Health SciencesOsteopathic Heritage Foundations; Brentwood Foundation; Colorado Springs Osteopathic... and other collaboratorsCompleted
-
IVIEW Therapeutics Inc.CompletedAdenoviral ConjunctivitisIndia
-
West Virginia School of Osteopathic MedicineUniversity of New England; American Academy of Osteopathy; Osteopathic Research...Completed
-
Fundación Renal Iñigo Alvarez De ToledoEffice Servicios Para la Investigacion S.L.TerminatedChronic Kidney Disease, UnspecifiedSpain
-
Duke UniversityTerumo BCTCompletedAllogenic Transfusion of Platelets During Cardiac SurgeryUnited States
-
Seoul National University HospitalJeysis MedicalNot yet recruiting
-
Baylor College of MedicineNot yet recruitingLymphoma | Leukemia, Myeloid, Acute | Leukemia, T-Cell | Leukemia, B-cellUnited States
-
Cerenovus, Part of DePuy Synthes Products, Inc.Active, not recruitingChronic Subdural HematomaUnited States