The effect of botulinum toxin A in the subscapular muscle in stroke patients with shoulder complaints: a randomised controlled trial
| ISRCTN | ISRCTN28311224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28311224 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | p02.133, NL210 (NTR247) |
| Sponsor | Medical Centre Haaglanden (The Netherlands) |
| Funder | Allergan (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 26/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H J Arwert
Scientific
Scientific
Medical Centre Haaglanden
P.O. Box 432
Den Haag
2501 CK
Netherlands
| Phone | +31 (0)70 330 2000 |
|---|---|
| h.arwert@mchaaglanden.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, triple blinded, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of botulinum toxin A in the subscapular muscle in stroke patients with shoulder complaints: a randomised controlled trial |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Botulinum toxin A (BOTOX®) |
| Primary outcome measure(s) |
1. Pain score (VAS) |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Total final enrolment | 21 |
| Key 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 |
| Key exclusion criteria | 1. Patients that cannot answer the pain questions 2. Patients that cannot sit |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medical Centre Haaglanden
Den Haag
2501 CK
Netherlands
2501 CK
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/04/2008 | 26/08/2021 | Yes | No |
