Clinical trial NCT00703287: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dystonia
Lead sponsor: South Glasgow University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Aberdeen
First posted: 2008-06-23
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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?


Eligibility criteria: 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.

Primary outcomes:
measure: To compare different types of physiotherapy for treating condition
timeFrame: Review at 1 month, 3 months & 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Southern General Hospital, 1345 Govan Road
state: Scotland
Study officials:
References: