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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00703287 |
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Date of registration:
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19/06/2008 |
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Primary sponsor: |
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Public title:
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Specialized Physiotherapy Program for Cervical Dystonia
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Scientific title:
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Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis). |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00703287 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All the following inclusion criteria must be met:
1. Any person over 16 years with primary cervical dystonia causing sufficient
interference in lifestyle that they wish to consider physiotherapy treatment and who
is able to give informed consent.
2. An abnormal neck position (Toronto Western Spasmodic Torticollis Rating Scale [TWSTR]
Part 1A > 0).
3. Patients receiving treatment with botulinum toxin (type A or B) injections (as most
will) provided they are on a stable botulinum toxin regimen (i.e. same dose and
injection pattern over the previous two injections). This includes those newly
diagnosed patients who choose to have botulinum toxin injections OR patients not
receiving botulinum toxin (either because of patient preference or previous lack of
effect) provided they plan to remain off botulinum toxin for the one year duration of
the trial. There will probably be few of these patients but we feel justified in
including them because there are no other treatments on offer and because it is
presently unknown whether physiotherapy requires botulinum toxin to weaken the
muscles in order to have an effect. Anecdotal reports suggest that it can be
effective even without botulinum toxin. However, the small numbers who are not
receiving botulinum toxin will be analysed as a separate subgroup initially to check
whether their response is significantly different to those receiving botulinum toxin.
Exclusion Criteria:
Patients with any of the following criteria will be excluded:
1. Secondary cervical dystonia (e.g. acute onset following trauma or secondary to drugs)
2. A fixed cervical dystonia which may imply a psychogenic component.
3. Radicular or myelopathic features where cervical manipulation may be dangerous.
4. Patients known to have fused cervical vertebrae from previous x-rays
5. Previous use of the Bleton technique.
6. Deep brain stimulation for cervical dystonia.
7. Dementia.
8. Unable to comply with visits for physiotherapy and assessment.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cervical Dystonia
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Intervention(s)
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Other: Physiotherapy
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Primary Outcome(s)
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To compare different types of physiotherapy for treating condition
[Time Frame: Review at 1 month, 3 months & 12 months]
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Secondary ID(s)
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SN07NE039
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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