- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041157
Botulinum Toxin Injection Efficiency
December 30, 2009 updated by: Jyväskylä Central Hospital
Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jyväskylä, Finland
- Central Finland Helth Care District
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
resistance training
|
Neck muscle trainings effect on botulinum toxin efficiency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle tone in splenius capitis muscle
Time Frame: five months
|
five months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain in the neck
Time Frame: five months
|
five months
|
Mobility in the neck
Time Frame: five months
|
five months
|
Neck muscle strength
Time Frame: five months
|
five months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jari Ylinen, MD, PhD, Senior Physician
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 30, 2009
First Posted (Estimate)
December 31, 2009
Study Record Updates
Last Update Posted (Estimate)
December 31, 2009
Last Update Submitted That Met QC Criteria
December 30, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSKS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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