Specialized Physiotherapy Program for Cervical Dystonia

Cervical Dystonia Clinical Trial

Official title:

Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703287
• Other study ID #: SN07NE039
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: February 1, 2013
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: South Glasgow University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Other:
• Physiotherapy
Specialized physiotherapy programme developed by Jean-Pierre Bleton
• Physiotherapy
Generic physiotherapy

Locations

Country	Name	City	State
United Kingdom	Southern General Hospital, 1345 Govan Road	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
Dr Donald Grosset	University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare different types of physiotherapy for treating condition		Review at 1 month, 3 months & 12 months	No