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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01041157
Other study ID # KSKS
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received December 8, 2009
Last updated December 30, 2009
Start date September 2008
Est. completion date December 2011

Study information

Verified date December 2009
Source Jyväskylä Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date December 2011
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Resistance training
Neck muscle trainings effect on botulinum toxin efficiency

Locations

Country Name City State
Finland Central Finland Helth Care District Jyväskylä

Sponsors (2)

Lead Sponsor Collaborator
Jyväskylä Central Hospital Eurostars

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle tone in splenius capitis muscle five months No
Secondary Pain in the neck five months No
Secondary Mobility in the neck five months No
Secondary Neck muscle strength five months No
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