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

Dr Donald Grosset1 site in 1 country110 target enrollmentJanuary 2008

ConditionsCervical Dystonia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cervical Dystonia
Sponsor: Dr Donald Grosset
Enrollment: 110
Locations: 1
Primary Endpoint: To compare different types of physiotherapy for treating condition
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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?

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

December 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr Donald Grosset

Responsible Party

Sponsor Investigator

Principal Investigator

Dr Donald Grosset

Consultant Neurologist

South Glasgow University Hospitals NHS Trust

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.
•Unable to comply with visits for physiotherapy and assessment.