|- candidate number||12362|
|- NTR Number||NTR3437|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2012|
|- Secondary IDs||2012_048 METC AMC|
|- Public Title||Standardized physical therapy for cervical dystonia.|
|- Scientific Title||Effectiveness of a standardized physical therapy program in Cervical Dystonia: A single blind randomized controlled trial.|
|- hypothesis||Disability due to Cervical Dystonia will be more reduced by Botulinum toxin injections in combination with PT according the treatment guideline than by BTX injections in combination with regular PT.|
|- Healt Condition(s) or Problem(s) studied||Disabilities, Functional status, Botulinum toxin, Cervical dystonia, Physical therapy|
|- Inclusion criteria||1. 100 patients with idiopathic CD;|
2. 30 years or older;
3. Treated with botulinum toxin.
|- Exclusion criteria||1. Secondary (including psychogenic) dystonia;|
2. Hereditary (dominant) forms of dystonia;
3. Segmental, hemi-, multifocal or generalized dystonia;
4. Patients who underwent neurosurgery;
5. Inability to understand written and spoken Dutch language;
6. Patients treated with the Bleton method by their physiotherapist at the moment of inclusion.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-1012|
|- planned closingdate||31-dec-2015|
|- Target number of participants||100|
|- Interventions||Patients in the intervention group will receive Botuline Toxin (BTX) injection combined with a standardized PT program for 12 months consisting of muscle stretching, artherogenic mobilistions and excersize therapy. Interventions will be provided by specially trained therapists.
Patients in the control group will receive BTX injections in combination with 12 months regular PT provided by common Dutch pracices.
|- Primary outcome||Disability, measured with the Toronto Western Spasmodic Torticollis Rating Scale.|
|- Secondary outcome||1. Severity of dystonie, with the TSUI scale;|
2. Pain, with a numeric rating scale;
3. Quality of life, with the Craniocervical dystonia Questionnaire 24;
4. Anxiety and depression with the Beck anxiety and depression inventory;
5. Healthcare costs and health utility with Quality Adjusted Life Years (QALY).
|- Timepoints||Baseline, after six months and 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J. Dool, van den|
|- CONTACT for SCIENTIFIC QUERIES|| J. Dool, van den|
|- Sponsor/Initiator ||Academic Medical Center (AMC, Amsterdam), University Medical Center Groningen (UMCG), Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Department of exercise therapy, Amsterdam School of Health Professions, Dutch Dystonia Patient Association|
|- Brief summary||Background: |
Cervical Dystonia (CD) is characterized by involuntary muscle contraction of the neck and abnormal positions of the head that affects daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into the neck muscles to decrease the abnormal head postures and pain. In addition, many patients are referred for physiotherapy with the aim to improve their functioning in daily life. A recent systematic review on allied health interventions in CD shows a lack of intervention studies that underpin or refute the effectiveness of physical therapy.
Our main goal is to evaluate the effectiveness and cost-utility of a standardized physical therapy (PT) programme compared with regular physiotherapy, both as add-on treatment to BTX-injections, on the ability of CD patients to perform everyday activities.
Multi-centre Single blind Randomized Controlled Trial.
100 patients with idiopathic cervical dystonia treated with botulinum toxin injections.
The primary outcome is disability in daily functioning, assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) after one year. The primary outcome for the economic evaluation is the costs per quality adjusted life-year.
Patients in the intervention group will receive Botuline Toxin (BTX) injection combined with a standardized PT program for 12 months according to the best evidence- / best practice treatment guideline. Interventions will be provided by specially trained therapists. Patients in the control group will receive BTX injections in combination with 12 months regular PT.
All data will be collected at baseline, after six months and after one year. In order to determine the additional effects of a PT program, measurements will be performed just before the botuline injections when botuline has the least effect on the symptoms of dystonia . Measurements will be performed by an independent blind assessor.
It is expected that disability due to CD will be more reduced by BTX injections in combination with a standardized PT programme according the treatment guideline than by BTX injections in combination with regular PT.
|- Main changes (audit trail)|
|- RECORD||10-mei-2012 - 2-jun-2012|