Specialized Physiotherapy Program for Cervical Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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?

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Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A2

Generic physiotherapy

Group Type SHAM_COMPARATOR

Physiotherapy

Intervention Type OTHER

Generic physiotherapy

A1

Specialized Physiotherapy

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type OTHER

Specialized physiotherapy programme developed by Jean-Pierre Bleton

Interventions

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Physiotherapy

Specialized physiotherapy programme developed by Jean-Pierre Bleton

Intervention Type OTHER

Physiotherapy

Generic physiotherapy

Intervention Type OTHER

Other Intervention Names

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Jean-Pierre Bleton

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes