Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON27111

Source

NTR

Brief title

N/A

Sponsors and support

Primary sponsor :
Allergan supplies the research medication

Intervention

Outcome measures

Primary outcome

1. Pain score (VAS);

2. Range of motion of glenohumeral joint.

Secondary outcome

N/A

Background summary

N/A

Study objective

We 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.

Study design

N/A

Intervention

Injection of 100 units of BOTOX (R) or 0.9% saline in subscapular muscle.

Public
Medical Center Haaglanden,
P.O. Box 432
H.J. Arwert
Lijnbaan 32
Den Haag 2501 CK
The Netherlands
+31 (0)70 3302000
h.arwert@mchaaglanden.nl
Scientific
Medical Center Haaglanden,
P.O. Box 432
H.J. Arwert
Lijnbaan 32
Den Haag 2501 CK
The Netherlands
+31 (0)70 3302000
h.arwert@mchaaglanden.nl

Inclusion criteria

1. 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 criteria

1. Patients that cannot answer the painquestions;

2. Patients that cannot sit.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
50
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL210
NTR-old NTR247
Other : p02.133
ISRCTN ISRCTN28311224

Summary results

N/A