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Trial record 80 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Botulinum Toxin Injection Efficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041157
Recruitment Status : Unknown
Verified December 2009 by Jyväskylä Central Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2009
Last Update Posted : December 31, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Torticollis Muscle Spasticity Other: Resistance training Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
Study Start Date : September 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: 1
resistance training
Other: Resistance training
Neck muscle trainings effect on botulinum toxin efficiency

Primary Outcome Measures :
  1. Muscle tone in splenius capitis muscle [ Time Frame: five months ]

Secondary Outcome Measures :
  1. Pain in the neck [ Time Frame: five months ]
  2. Mobility in the neck [ Time Frame: five months ]
  3. Neck muscle strength [ Time Frame: five months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041157

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

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Responsible Party: Ylinen Jari, Jyvaskylä Central Hospital Identifier: NCT01041157     History of Changes
Other Study ID Numbers: KSKS
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: December 31, 2009
Last Verified: December 2009

Keywords provided by Jyväskylä Central Hospital:
Botulinum Toxins

Additional relevant MeSH terms:
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Dystonic Disorders
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs