Botulinum Toxin Injection Efficiency

Phase 1

• Conditions: Muscle Spasticity; Torticollis

• Registration Number: NCT01041157
• Lead Sponsor: Jyväskylä Central Hospital

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.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-30
• Last Update Submitted: 2009-12-30
• Study First Posted: 2009-12-31
• Last Update Posted: 2009-12-31
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Muscle tone in splenius capitis muscle	five months

Secondary Outcome Measures

Name	Time	Method
Neck muscle strength	five months
Mobility in the neck	five months
Pain in the neck	five months

Trial Locations

Locations (1)

Central Finland Helth Care District; 🇫🇮 Jyväskylä, Finland