Specialized Physiotherapy Program for Cervical Dystonia

Not Applicable

Completed

• Conditions: Cervical Dystonia
• Interventions: Other: Physiotherapy

• Registration Number: NCT00703287
• Lead Sponsor: Dr Donald Grosset

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Primary Completion: 2010-05
• Study Completion: 2010-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Physiotherapy	Generic physiotherapy
A1	Physiotherapy	Specialized Physiotherapy

Primary Outcome Measures

Name	Time	Method
To compare different types of physiotherapy for treating condition	Review at 1 month, 3 months & 12 months

Trial Locations

Locations (1)

Southern General Hospital, 1345 Govan Road; 🇬🇧 Glasgow, Scotland, United Kingdom