Contact information
Type
Scientific
Primary contact
Dr H J Arwert
ORCID ID
Contact details
Medical Centre Haaglanden
P.O. Box 432
Den Haag
2501 CK
Netherlands
+31 (0)70 330 2000
h.arwert@mchaaglanden.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
p02.133
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, triple blinded, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Complaints of arm, complaints of shoulder
Intervention
Injection of 100 units of BOTOX (R) or 0.9% saline in subscapular muscle.
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin A (BOTOX®)
Primary outcome measures
1. Pain score (VAS)
2. Range of motion of glenohumeral joint
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2002
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
1. Patients that cannot answer the pain questions
2. Patients that cannot sit
Recruitment start date
01/11/2002
Recruitment end date
01/11/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medical Centre Haaglanden
Den Haag
2501 CK
Netherlands
Sponsor information
Organisation
Medical Centre Haaglanden (The Netherlands)
Sponsor details
Department of Rehabilitation
P.O. Box 432
Den Haag
2501 CK
Netherlands
info@mchaaglanden.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Allergan (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary