Specialized Physiotherapy Program for Cervical Dystonia

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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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern General Hospital, 1345 Govan Road

Glasgow, Scotland, G51 4TF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

Specialized physiotherapy programme developed by Jean-Pierre Bleton

Other names: Jean-Pierre Bleton

Primary outcomes

To compare different types of physiotherapy for treating condition

Time frame: Review at 1 month, 3 months & 12 months

Sponsors and collaborators

Lead sponsor

Dr Donald Grosset

Other

Collaborators

University of Aberdeen

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jun 23, 2008
Registry last updated: Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed