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The effect of botuline toxin A in the subscapular muscle in stroke patients with shoulder complaints; a randomized controlled trial.


- candidate number1427
- NTR NumberNTR247
- ISRCTNISRCTN28311224
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsp02.133 
- Public TitleThe effect of botuline toxin A in the subscapular muscle in stroke patients with shoulder complaints; a randomized controlled trial.
- Scientific TitleThe effect of botuline toxin A in the subscapular muscle in stroke patients with shoulder complaints; a randomized controlled trial.
- ACRONYMN/A
- hypothesisWe assume that relaxation of the subscapular muscle will lead to pain reduction and improvement of mobility in stroke patients with shoulder- or armpain and limited range of motion of the shoulder.
- Healt Condition(s) or Problem(s) studiedComplaints of Arm, Neck and Shoulders (CANS), Complaints of shoulder, Stroke
- Inclusion criteria1. Stroke shoulder- or armpain longer than 1 week;
2. VAS pain 4 or higher;
Glenohumeral exorotation on the affected side is limited to 50% compared to the uninvolved side;
3. 18 years or older.
- Exclusion criteria1. Patients that cannot answer the painquestions;
2. Patients that cannot sit.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2002
- planned closingdate1-nov-2006
- Target number of participants50
- InterventionsInjection of 100 units of BOTOX (R) or 0.9% saline in subscapular muscle.
- Primary outcome1. Pain score (VAS);
2. Range of motion of glenohumeral joint.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES H.J. Arwert
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.H. Arendzen
- Sponsor/Initiator Medical Center Haaglanden, Department of Rehabilitation
- Funding
(Source(s) of Monetary or Material Support)
Allergan
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-sep-2005 - 9-sep-2009


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