Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
29/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mchaaglanden.nl/

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

Publication citations

Additional files

Editorial Notes