Clinical trial NCT02107638: Effect of Osteopathic Manipulative Medicine on Parkinson Disease
Official title: Effect of Osteopathic Manipulative Medicine on Motor Function, Balance, and Neuroprotective Serum Markers in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Osteopathic Manipulative Medicine
Falls
Balance
Motor function
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2014-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that affects the patient's mobility, balance and cognition. Tremor, slowed movements, and rigidity are physical symptoms which contribute to postural and gait abnormalities seen in many PD patients. Other symptoms include loss of balance and restricted range of motion, increasing the risk of falling. Osteopathic manipulative medicine (OMM) is a form of manual treatment provided by osteopathic physicians. 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 impact of OMM on balance, motor function, and falling in PD patients. We are also going to screen for serum biomarker changes to investigate the potential effects of OMM. Our research team and institution have experience in providing osteopathic care and physical rehabilitation for PD patients. In this study, balance and motor function will be evaluated for each subject throughout the study period. We will also keep track of the number of falls. Balance will be measured using Sensory Organization Test (SOT) and motor function will be measured using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Both tools are non-invasive and clinically proven methods for measuring balance and motor function.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of falls
timeFrame: 10 week period
Secondary outcomes:
measure: Balance
timeFrame: 10 weeks
Other outcomes:
measure: Motor function
timeFrame: 10-weeks
measure: Serum biomarkers
timeFrame: 6 weeks
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology - Academic Health Care Center
state: New York
Study officials:
affiliation: NYIT College of Osteopathic Medicine
name: Sheldon Yao, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.