Specialized Physiotherapy Program for Cervical Dystonia

NCT00703287 | Completed

• 1 other identifier: SN07NE039
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.What are the economic implications of the specialized physiotherapy programme?

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• To compare different types of physiotherapy for treating condition

  Review at 1 month, 3 months & 12 months

Study Arms (2)

A2

SHAM COMPARATOR

Generic physiotherapy

Other: Physiotherapy

A1

EXPERIMENTAL

Specialized Physiotherapy

Other: Physiotherapy

Interventions

Physiotherapy OTHER

Specialized physiotherapy programme developed by Jean-Pierre Bleton

Also known as: Jean-Pierre Bleton

A1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Donald Grosset: lead
• University of Aberdeen: collaborator

Study Sites (1)

Southern General Hospital, 1345 Govan Road

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Torticollis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 4, 2013

Record last verified: 2013-02

Locations

GB (1)