Botulinum Toxin Injection Efficiency

December 30, 2009 updated by: Jyväskylä Central Hospital

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jyväskylä, Finland
        • Central Finland Helth Care District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
resistance training
Neck muscle trainings effect on botulinum toxin efficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle tone in splenius capitis muscle
Time Frame: five months
five months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain in the neck
Time Frame: five months
five months
Mobility in the neck
Time Frame: five months
five months
Neck muscle strength
Time Frame: five months
five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jari Ylinen, MD, PhD, Senior Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2009

Last Update Submitted That Met QC Criteria

December 30, 2009

Last Verified

December 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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