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ISRCTN
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ISRCTN28311224
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ClinicalTrials.gov identifier
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Public title
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The effect of botulinum toxin A in the subscapular muscle in stroke patients with shoulder complaints: a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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p02.133
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Study hypothesis
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We assume that relaxation of the subscapular muscle will lead to pain reduction and improvement of mobility in stroke patients with shoulder- or arm-pain and limited range of motion of the shoulder.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, placebo controlled, parallel group, triple blinded, multicentre trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Complaints of arm, complaints of shoulder
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Participants - inclusion criteria
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1. Stroke shoulder- or arm pain longer than one week
2. Visual Analogue Scale (VAS) pain four or higher
3. Glenohumeral exorotation on the affected side is limited to 50% compared to the uninvolved side
4. 18 years or older
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Participants - exclusion criteria
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1. Patients that cannot answer the pain questions
2. Patients that cannot sit
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Anticipated start date
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01/11/2002
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Anticipated end date
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01/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Injection of 100 units of BOTOX (R) or 0.9% saline in subscapular muscle.
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Primary outcome measure(s)
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1. Pain score (VAS)
2. Range of motion of glenohumeral joint
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Allergan (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
H J
Arwert
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Address
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Medical Centre Haaglanden
P.O. Box 432
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City/town
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Den Haag
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Zip/Postcode
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2501 CK
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Country
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Netherlands
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Tel
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+31 (0)70 330 2000
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Email
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h.arwert@mchaaglanden.nl
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Sponsor
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Medical Centre Haaglanden (The Netherlands)
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Address
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Department of Rehabilitation
P.O. Box 432
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City/town
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Den Haag
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Zip/Postcode
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2501 CK
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Country
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Netherlands
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Email
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info@mchaaglanden.nl
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Sponsor website:
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http://www.mchaaglanden.nl/
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Date applied
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20/12/2005
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Last edited
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29/03/2007
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Date ISRCTN assigned
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20/12/2005
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