Specialized Physiotherapy Program for Cervical Dystonia

This study has been completed.
Sponsor:
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00703287
First received: June 19, 2008
Last updated: February 1, 2013
Last verified: February 2013

June 19, 2008
February 1, 2013
January 2008
May 2010   (final data collection date for primary outcome measure)
To compare different types of physiotherapy for treating condition [ Time Frame: Review at 1 month, 3 months & 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00703287 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Specialized Physiotherapy Program for Cervical Dystonia
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:

  1. 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?
  2. 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?
  3. What are the economic implications of the specialized physiotherapy programme?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Dystonia
  • Other: Physiotherapy
    Specialized physiotherapy programme developed by Jean-Pierre Bleton
    Other Name: Jean-Pierre Bleton
  • Other: Physiotherapy
    Generic physiotherapy
  • Sham Comparator: A2
    Generic physiotherapy
    Intervention: Other: Physiotherapy
  • Experimental: A1
    Specialized Physiotherapy
    Intervention: Other: Physiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00703287
SN07NE039
No
Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
Dr Donald Grosset
University of Aberdeen
Not Provided
South Glasgow University Hospitals NHS Trust
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP