Botulinum Toxin Injection Efficiency

Muscle Spasticity Clinical Trial

Official title:

Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01041157
• Other study ID #: KSKS
• 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

• Muscle Spasticity
• Torticollis

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