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Open Access Study protocol

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

Joost van den Dool12, Bart Visser2, J Hans TM Koelman3, Raoul HH Engelbert45 and Marina AJ Tijssen1*

Author Affiliations

1 Department of Neurology, University Medical Centre Groningen, University of Groningen, Hanzeplein 1, Groningen, 9700 RB, The Netherlands

2 Department Exercise Therapy, Amsterdam School of Health Professions, Tafelbergweg, Amsterdam, 51,1105 BD, The Netherlands

3 Department of Neurology, Academic Medical Centre Amsterdam, Meibergdreef 9, Amsterdam, 1100 DD, The Netherlands

4 Department of Physiotherapy, Amsterdam School of Health Professions, Tafelbergweg 51, Amsterdam, 1105 BD, The Netherlands

5 Department of Rehabilitation, Academic Medical Center, Meibergdreef 9, Amsterdam, 1100 DD, The Netherlands

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BMC Neurology 2013, 13:85  doi:10.1186/1471-2377-13-85

Published: 15 July 2013

Abstract

Background

Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions.

Methods/design

The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter.

Discussion

Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia.

Trial registration

Number Dutch Trial registration (Nederlands Trial Register): NTR3437

Keywords:
Cervical dystonia; Spasmodic torticollis; Physical therapy; Botulinum toxin; Activities of daily living; Quality of life