Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1
| ISRCTN | ISRCTN84121379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84121379 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Maastricht (The Netherlands) - Pain Centre |
| Funders | University Hospital Maastricht (The Netherlands) - Pain Centre, Parke-Davis Nederland (The Netherlands) |
- Submission date
- 07/06/2004
- Registration date
- 08/06/2004
- Last edited
- 12/09/2011
- 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 Wim E.J. Weber
Scientific
Scientific
Department of Neurology
University Hospital Maastricht
PO Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3875117 |
|---|---|
| wweb@neurologie.azm.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Complex Regional Pain Syndrome (CRPS) |
| Intervention | Gabapentin versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gabapentin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 02/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 58 |
| Key inclusion criteria | 1. Patients with Complex Regional Pain Syndrome (CRPS) 2. With pain Visual Analogue Scale (VAS) greater than 3 3. Have undergone sympathetic blocks, mannitol infusions and Transcutaneous Electrical Nerve Stimulation (TENS) without success |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/11/1998 |
| Date of final enrolment | 02/12/1999 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Neurology
Maastricht
6202 AZ
Netherlands
6202 AZ
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 | Results | 29/09/2004 | Yes | No |
