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Botulinum Toxin Injection Efficiency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Jyväskylä Central Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eurostars
Information provided by:
Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT01041157
First received: December 8, 2009
Last updated: December 30, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Torticollis
Muscle Spasticity
 Other: Resistance training
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by Jyväskylä Central Hospital:

Primary Outcome Measures:
  • Muscle tone in splenius capitis muscle [ Time Frame: five months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain in the neck [ Time Frame: five months ] [ Designated as safety issue: No ]
  • Mobility in the neck [ Time Frame: five months ] [ Designated as safety issue: No ]
  • Neck muscle strength [ Time Frame: five months ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
resistance training
 Other: Resistance training
Neck muscle trainings effect on botulinum toxin efficiency

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041157

Locations
Finland
Central Finland Helth Care District
Jyväskylä, Finland
Sponsors and Collaborators
Jyväskylä Central Hospital
Eurostars
Investigators
Study Director: Jari Ylinen, MD, PhD Senior physician
  More Information

No publications provided

Responsible Party: Ylinen Jari, Jyvaskylä Central Hospital
ClinicalTrials.gov Identifier: NCT01041157     History of Changes
Other Study ID Numbers: KSKS
Study First Received: December 8, 2009
Last Updated: December 30, 2009
Health Authority: Finland: Ethics Committee

Keywords provided by Jyväskylä Central Hospital:
Torticollis
Botulinum Toxins

Additional relevant MeSH terms:
Muscle Spasticity
Torticollis
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dystonic Disorders
 Movement Disorders
Central Nervous System Diseases
Dystonia
Dyskinesias
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013