Back to resultsBotulinum Toxin Injection Efficiency
Primary Purpose
Torticollis, Muscle Spasticity
Status
Unknown status
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Torticollis focused on measuring Torticollis, Botulinum Toxins
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of cervical dystonia
- Spasticity in splenius capitis muscle
- Regular treatment with botulinum toxin injection
Exclusion Criteria:
- Don't want to take part the Trial
- Very long distance from home to Jyväskylä Central Hospital
Sites / Locations
- Central Finland Helth Care District
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
resistance training
Outcomes
Primary Outcome Measures
Muscle tone in splenius capitis muscle
Secondary Outcome Measures
Pain in the neck
Mobility in the neck
Neck muscle strength
Full Information
NCT ID
NCT01041157
First Posted
December 8, 2009
Last Updated
December 30, 2009
Sponsor
Jyväskylä Central Hospital
Collaborators
Eurostars
1. Study Identification
Unique Protocol Identification Number
NCT01041157
Brief Title
Botulinum Toxin Injection Efficiency
Official Title
Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Jyväskylä Central Hospital
Collaborators
Eurostars
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.
Detailed Description
The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torticollis, Muscle Spasticity
Keywords
Torticollis, Botulinum Toxins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
resistance training
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Neck muscle trainings effect on botulinum toxin efficiency
Primary Outcome Measure Information:
Title
Muscle tone in splenius capitis muscle
Time Frame
five months
Secondary Outcome Measure Information:
Title
Pain in the neck
Time Frame
five months
Title
Mobility in the neck
Time Frame
five months
Title
Neck muscle strength
Time Frame
five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of cervical dystonia
Spasticity in splenius capitis muscle
Regular treatment with botulinum toxin injection
Exclusion Criteria:
Don't want to take part the Trial
Very long distance from home to Jyväskylä Central Hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Ylinen, MD, PhD
Organizational Affiliation
Senior physician
Official's Role
Study Director
Facility Information:
Facility Name
Central Finland Helth Care District
City
Jyväskylä
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Injection Efficiency
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