Specialized Physiotherapy Program for Cervical Dystonia
This study has been completed.
University of Aberdeen
Information provided by (Responsible Party):
Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
First received: June 19, 2008
Last updated: February 1, 2013
Last verified: February 2013
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?
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).
Primary Outcome Measures:
- To compare different types of physiotherapy for treating condition [ Time Frame: Review at 1 month, 3 months & 12 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
Sham Comparator: A2
Specialized physiotherapy programme developed by Jean-Pierre Bleton
Other Name: Jean-Pierre Bleton
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
- Unable to comply with visits for physiotherapy and assessment.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00703287
|Southern General Hospital, 1345 Govan Road
|Glasgow, Scotland, United Kingdom, G51 4TF |
Dr Donald Grosset
University of Aberdeen
||Dr Donald Grosset, Consultant Neurologist, South Glasgow University Hospitals NHS Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 19, 2008
||February 1, 2013
||Scotland: Scottish Executive Health Department
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2016
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms