Percutaneous sympathetic blockade in complex regional pain syndrome type 1: a prospective clinical investigation on predictors of sympatheticaly maintained pain
| ISRCTN | ISRCTN71968956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71968956 |
| Secondary identifying numbers | BSIK03016 |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 02/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System 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 J. Geurts
Scientific
Scientific
Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3877673 |
|---|---|
| Jgeurt@sane.azm.nl |
Study information
| Study design | Non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Percutaneous sympathetic blockade in complex regional pain syndrome type 1: a prospective clinical investigation on predictors of sympatheticaly maintained pain |
| Study acronym | SYMBLOC |
| Study objectives | The cold phenotype of CRPS1 is associated with a better response to percutaneous sympathetic blockade as opposed to the warm type of CRPS1. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Complex regional pain syndrome type 1 (CRPS I) (Causalgia) |
| Intervention | Upper extremity CRPS-1: percutaneous blockade of stellate ganglion at C7 with one single injection of bupivacaine 0.25%. Lower extremity CRPS-1: percutaneous blockade of lumbar sympathetic chain at L3 with a single injection of bupivacaïne 0.25%. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | Pain relief in the first week after blockade as measured three times daily in a pain diary where, 0 = no pain and 10 = worst imaginable pain |
| Secondary outcome measures | The following predictors of pain relief after sympathetic blockade will be measured: 1. Pain intensity on an NRS scale of 0 to 10 2. Subjective and objective skin temperature 3. Hyper- and hypo-esthesia 4. Allodynia 5. Hyper- and hypo-algesia 6. The presence of dystonia 7. Tremor and myoclonus |
| Overall study start date | 10/04/2006 |
| Completion date | 10/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 124 |
| Total final enrolment | 49 |
| Key inclusion criteria | Adult (18 years or more) male or female patients with CRPS1 as diagnosed by International Association for the Study of Pain (IASP) criteria, with a duration of 12 months or less with moderate to severe pain (mean numerical rating scale [NRS] of more than 4 in the previous week as measured three times daily in a pain diary where, 0 = no pain and 10 = worst imaginable pain) and one extremity involved. |
| Key exclusion criteria | 1. Patients of less than 18 years of age 2. The existence of significant impairment of blood coagulation or the use of oral anticoagulant medication 3. Patients suffering from diabetic polyneuropathia 4. Patients who are unlikely to comply with study requirements 5. Pregnant women 6. CRPS1 with a duration of more than 12 months |
| Date of first enrolment | 10/04/2006 |
| Date of final enrolment | 10/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Hospital Maastricht (AZM)
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
Academic Hospital Maastricht (AZM) and Dutch Consortium for Research on Trauma Related Neuronal Dysfunction (TREND)
University/education
University/education
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
"ROR" |
https://ror.org/02d9ce178 |
|---|
Funders
Funder type
Government
Ministry of Economic Affairs (BSIK03016)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/01/2012 | 02/05/2019 | Yes | No |
Editorial Notes
02/05/2019: Publication reference and total final enrolment added.
