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

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ClinicalTrials.gov Identifier: NCT02420106
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Procedure: Osteopathic Manipulative Medicine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia
Study Start Date : February 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: OMM alone
Subjects who are not receiving botulinum treatment consenting to Osteopathic Manipulative Medicine intervention
Procedure: Osteopathic Manipulative Medicine
Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.

Active Comparator: OMM plus Botulinum
Subjects who are receiving botulinum treatment and will have osteopathic manipulative medicine intervention.
Procedure: Osteopathic Manipulative Medicine
Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.




Primary Outcome Measures :
  1. Change in Motor Function [ Time Frame: baseline and 5 weeks ]
    Motor function will be assessed by Vicon 3-Dimensional analysis of the subjects' biomechanics while walking and 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.


Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: baseline and 5 weeks ]
    Quality of Life will be assessed by the CDIP-58 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420106


Contacts
Contact: Jayme Mancini, DO 631-686-1237 jmancini@nyit.edu

Locations
United States, New York
New York Institute of Technology Recruiting
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: Jayme Mancini, DO New York Institute of Technology

Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT02420106     History of Changes
Other Study ID Numbers: BHS-983
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by New York Institute of Technology:
cervical dystonia
neck pain
OMM
spasmodic torticollis

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases