Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia



Status:Recruiting
Conditions:Neurology, Orthopedic, Women's Studies
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:2 - 100
Updated:10/12/2017
Start Date:February 2014
End Date:August 2018
Contact:Jayme Mancini, DO
Email:jmancini@nyit.edu
Phone:631-686-1237

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The purpose of the proposed research is to determine if Osteopathic manipulative medicine
(OMM) used alone or in combination with the standard treatment of botulinum toxin
intramuscular injections improves motor function and quality of life amongst people with
cervical (neck) dystonia.

Cervical dystonia, also called spasmodic torticollis, is a type of neurological disorder
characterized by spastic muscles in the neck that is largely underdiagnosed despite its
progression to disability during midlife. Cervical dystonia occurs in at least 0.390% of the
United States population in 2007 (390 per 100,000). Symptoms commonly include stiffness,
pain, headaches, difficulty swallowing, fatigue, and difficulty walking. The current standard
treatment is intramuscular botulinum toxin injection every 90 days. The effect of the
botulinum toxin increases gradually, and then it decreases until there is little to no effect
at 90 days post-injection. The purpose of the proposed research is to determine if
Osteopathic manipulative medicine (OMM) used in combination with the standard treatment of
botulinum toxin intramuscular injections improves motor function and quality of life amongst
people with cervical dystonia.

The investigators propose to use Vicon 3-dimensional gait and posture analysis to determine
the biomechanics of subjects with primary cervical dystonia to compare with full body
complaints from a standard spasmodic torticollis/cervical dystonia questionnaire as well as
the osteopathic structural exam. These measures will be assessed before and after four OMM
treatments. In addition, the investigators propose to use osteopathic manual medicine along
with botulinum toxin injection to improve the subjects' pain and motor function as evaluated
by Vicon 3-dimensional gait and posture analysis and questionnaire regarding quality of life.
Preliminary case reports suggest that Osteopathic manipulative medicine without botulinum
toxin injections improved pain, posture, gait, and quality of life in four adult subjects as
well as improved head tilt in two children (two- and five-years old). The central hypothesis
is that osteopathic manual medicine will significantly improve the range of motion, motor
function, and quality of life of subjects with primary cervical dystonia.

Aims:

Aim I. To determine 3-Dimensional gait and posture biomechanics of subjects with untreated
primary cervical dystonia while walking, and to investigate the effectiveness of OMM in
treating abnormal biomechanics in these subjects.

Hypothesis I: People with cervical dystonia have similar abnormalities in posture and
structural exam that significantly alters their gait and full body motor function that can be
significantly improved with OMM.

Experimental approach: Motor function will be assessed by Vicon 3-Dimensional analysis using
34 of the subjects while walking will depict stride length and arm swing on each side of the
body as well as the posture of the shoulder and pelvic girdle with reference to the coronal,
transverse, and sagittal planes. Quality of life will be assessed by the Cervical Dystonia
Impact Profile (CDIP)-58 questionaire. Four weekly OMM diagnosis and treatment will be done,
and then, motor function and quality of life will be reassessed. Total participation in the
study is expected to last for 5-7 weeks.

Expected outcomes: The spasticity in the neck will affect motor function of the whole body.
There will be decreased stride length and arm swing on the side of the body with the neck
muscle spasm. The shoulder girdle and pelvis will be continuously rotated around a vertical
axis the same direction as the head in reference to the feet and direction of walking. The
shoulder and pelvic girdles will be tilted such that they are closer together on one side
than the other side due to side-bending of the torso. We also expect that there will be an
indirect relationship between age and motor function. OMM is expected to significantly
improve motor function and quality of life.

Significance: The impact of the neck muscle spasticity on full body biomechanics of subjects
with primary cervical dystonia is not well understood, and the results can be used to improve
assessment of function as well as management of the disorder.

Aim II. To determine whether osteopathic manual medicine used during the first four weeks
following botulinum toxin intramuscular injection will significantly improve the joint range
of motion, motor function, and quality of life of subjects with primary cervical dystonia .

Hypothesis II: Osteopathic manual medicine will improve the range of motion of the neck,
symmetry of posture and gait, and quality of life of subjects with primary cervical dystonia.

Experimental approach: Subjects being treated with botulinum toxin injections will be
evaluated with a standard spasmodic torticollis form (to be filled out by physician),
cervical dystonia questionnaire regarding quality of life, and Vicon 3-Dimensional gait and
posture analysis before and after four weekly treatments with OMM (n≥8) for comparison with
subjects in a no-OMM control condition (n≥ 8).

Expected outcomes: Subjects will have improved quality of life in regard to head and neck
symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood, and
psychosocial functioning. Subjects will have improved joint range of motion and motor
function.

Significance: Although physicians specializing in osteopathic manual medicine treat patients
with various types of dystonia, the effectiveness of osteopathic manual medicine in treating
primary cervical dystonia is not established, and thus, osteopathic manual medicine is not
recognized or recommended as adjunctive therapy. The botulinum toxin is injected into spastic
neck muscles. However, there is no adjunctive procedure recommended for treating the rest of
the symptoms associated with the illness. 3-dimensional characterization of motor function
has been used in children with cerebral palsy and generalized dystonia before and after
surgical intervention, and using a similar method may demonstrate how OMM can prevent people
from becoming disabled.

Inclusion Criteria:

- clinical diagnosis of cervical dystonia or spasmodic torticollis

- ages 2-100

Exclusion Criteria:

- no clinical diagnosis of cervical dystonia or spasmodic torticollis

- symptoms beginning over the age of 40

- pregnant women are excluded from Aim 2
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Old Westbury, New York 11568
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Old Westbury, NY
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