Specialized Physiotherapy Program for Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
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.
Sites / Locations
- Southern General Hospital, 1345 Govan Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
A2
A1
Arm Description
Generic physiotherapy
Specialized Physiotherapy
Outcomes
Primary Outcome Measures
To compare different types of physiotherapy for treating condition
Secondary Outcome Measures
Full Information
NCT ID
NCT00703287
First Posted
June 19, 2008
Last Updated
February 1, 2013
Sponsor
Dr Donald Grosset
Collaborators
University of Aberdeen
1. Study Identification
Unique Protocol Identification Number
NCT00703287
Brief Title
Specialized Physiotherapy Program for Cervical Dystonia
Official Title
Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Donald Grosset
Collaborators
University of Aberdeen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A2
Arm Type
Sham Comparator
Arm Description
Generic physiotherapy
Arm Title
A1
Arm Type
Experimental
Arm Description
Specialized Physiotherapy
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Jean-Pierre Bleton
Intervention Description
Specialized physiotherapy programme developed by Jean-Pierre Bleton
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Generic physiotherapy
Primary Outcome Measure Information:
Title
To compare different types of physiotherapy for treating condition
Time Frame
Review at 1 month, 3 months & 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Southern General Hospital, 1345 Govan Road
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
12. IPD Sharing Statement
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Specialized Physiotherapy Program for Cervical Dystonia
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