Specialized Physiotherapy Program for Cervical Dystonia

This study has been completed.
Sponsor:
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00703287
First received: June 19, 2008
Last updated: February 1, 2013
Last verified: February 2013
  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:

  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?

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:


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 ]

Enrollment: 110
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: May 2010 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dr Donald Grosset
University of Aberdeen
  More Information

No publications provided

Responsible Party: Dr Donald Grosset, Consultant Neurologist, South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00703287     History of Changes
Other Study ID Numbers: SN07NE039
Study First Received: June 19, 2008
Last Updated: February 1, 2013
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 July 24, 2014