Specialized Physiotherapy Program for Cervical Dystonia
February 1, 2013 updated by: Dr Donald Grosset
Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).
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 with a view to undertaking a larger UK-wide trial looking at overall cost-effectiveness. Specifically, the investigators wish to establish:
- Whether this specific physiotherapy program for cervical dystonia improves patient outcomes in terms of neck position, pain, disability, and quality of life compared to simple physiotherapy advice?
- What is the minimal clinically important change in the new CDIP-58 quality of life measure for cervical dystonia from a patient's perspective that could then be used to plan a definitive trial of this technique?
- What are the economic implications of the specialized physiotherapy programme?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
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
-
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Scotland
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Glasgow, Scotland, United Kingdom, G51 4TF
- Southern General Hospital, 1345 Govan Road
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-
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
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.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: A2
Generic physiotherapy
|
Specialized physiotherapy programme developed by Jean-Pierre Bleton
Other Names:
Generic physiotherapy
|
|
Experimental: A1
Specialized Physiotherapy
|
Specialized physiotherapy programme developed by Jean-Pierre Bleton
Other Names:
Generic physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare different types of physiotherapy for treating condition
Time Frame: Review at 1 month, 3 months & 12 months
|
Review at 1 month, 3 months & 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 20, 2008
First Posted (Estimate)
June 23, 2008
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
February 1, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SN07NE039
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.