Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Osteopathic Manipulative Medicine
Intervention type(s): Procedure
Intervention description(s): Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical dystonia; neck pain; OMM; spasmodic torticollis