Specialized Physiotherapy Program for Cervical Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by South Glasgow University Hospitals NHS Trust. Recruitment status was Active, not recruiting

First Received on June 19, 2008. Last Updated on February 6, 2009 History of Changes

Sponsor:	South Glasgow University Hospitals NHS Trust
Collaborator:	University of Aberdeen
Information provided by:	South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00703287

Purpose

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?

Condition	Intervention
Cervical Dystonia	Other: Physiotherapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

Further study details as provided by South Glasgow University Hospitals NHS Trust:

Primary Outcome Measures:

To compare different types of physiotherapy for treating condition [ Time Frame: Review at 1 month, 3 months & 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: A2 Generic physiotherapy	Other: Physiotherapy Generic physiotherapy
Experimental: A1 Specialized Physiotherapy	Other: Physiotherapy Specialized physiotherapy programme developed by Jean-Pierre Bleton Other Name: Jean-Pierre Bleton

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703287

Locations

United Kingdom
Southern General Hospital, 1345 Govan Road
Glasgow, Scotland, United Kingdom, G51 4TF

Sponsors and Collaborators

South Glasgow University Hospitals NHS Trust

University of Aberdeen

More Information

No publications provided

Responsible Party:	Dr Donald Grosset, NHS Greater Glasgow & Clyde
ClinicalTrials.gov Identifier:	NCT00703287 History of Changes
Other Study ID Numbers:	SN07NE039
Study First Received:	June 19, 2008
Last Updated:	February 6, 2009
Health Authority:	Scotland: Scottish Executive Health Department

Additional relevant MeSH terms:

Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012