Status:
COMPLETED
Specialized Physiotherapy Program for Cervical Dystonia
Lead Sponsor:
Dr Donald Grosset
Collaborating Sponsors:
University of Aberdeen
Conditions:
Cervical Dystonia
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The investigators wish to establish on a small scale the effectiveness of adding the physiotherapy programme developed by Jean-Pierre Bleton to the present standard treatment for cervical dystonia wit...
Eligibility Criteria
Inclusion
- All the following inclusion criteria must be met:
- 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.
- An abnormal neck position (Toronto Western Spasmodic Torticollis Rating Scale \[TWSTR\] Part 1A \> 0).
- 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
- Patients with any of the following criteria will be excluded:
- Secondary cervical dystonia (e.g. acute onset following trauma or secondary to drugs)
- A fixed cervical dystonia which may imply a psychogenic component.
- Radicular or myelopathic features where cervical manipulation may be dangerous.
- Patients known to have fused cervical vertebrae from previous x-rays
- Previous use of the Bleton technique.
- Deep brain stimulation for cervical dystonia.
- Dementia.
- Unable to comply with visits for physiotherapy and assessment.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00703287
Start Date
January 1 2008
End Date
December 1 2010
Last Update
February 4 2013
Active Locations (1)
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1
Southern General Hospital, 1345 Govan Road
Glasgow, Scotland, United Kingdom, G51 4TF