Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJuly 2, 2019
July 1, 2019
5 years
February 18, 2014
July 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Motor Function
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.
baseline and 5 weeks
Secondary Outcomes (1)
Change in Quality of Life
baseline and 5 weeks
Study Arms (2)
OMM alone
ACTIVE COMPARATORSubjects who are not receiving botulinum treatment consenting to Osteopathic Manipulative Medicine intervention
OMM plus Botulinum
ACTIVE COMPARATORSubjects who are receiving botulinum treatment and will have osteopathic manipulative medicine intervention.
Interventions
Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.
Eligibility Criteria
You may qualify if:
- clinical diagnosis of cervical dystonia or spasmodic torticollis
- ages 2-100
You may not qualify if:
- no clinical diagnosis of cervical dystonia or spasmodic torticollis
- symptoms beginning over the age of 40
- pregnant women are excluded from Aim 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Institute of Technology
Old Westbury, New York, 11568, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayme Mancini, DO
New York Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2014
First Posted
April 17, 2015
Study Start
February 1, 2014
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
July 2, 2019
Record last verified: 2019-07