search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Percutaneous sympathetic blockade in complex regional pain syndrome type 1; A prospective clinical investigation on predictors of sympatheticaly maintained pain.


- candidate number2050
- NTR NumberNTR651
- ISRCTNISRCTN71968956
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR4-apr-2006
- Secondary IDsMinistry of economic affairs, number BSIK03016 
- Public TitlePercutaneous sympathetic blockade in complex regional pain syndrome type 1; A prospective clinical investigation on predictors of sympatheticaly maintained pain.
- Scientific TitlePercutaneous sympathetic blockade in complex regional pain syndrome type 1; A prospective clinical investigation on predictors of sympatheticaly maintained pain.
- ACRONYMSYMBLOC (Sympathetic blockade in CRPS1)
- hypothesisThe cold fenotype of CRPS1 is associated with a better respons to percutaneous sympathetic blockade as opposed to the warm type of CRPS1.
- Healt Condition(s) or Problem(s) studiedComplex regional pain syndrome type 1 (CRPS I)
- Inclusion criteriaAdult (18 years or more) male or female patiŽnts with CRPS1 as diagnosed by IASP criteria, with a duration of 12 months or less with moderate to severe pain (mean NRS of more than 4 in the previous week as measured 3 times daily in a pain diary with 0=no pain and 10= worst imaginable pain) and one extremity involved.
- Exclusion criteria1. PatiŽnts 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 10-apr-2006
- planned closingdate10-apr-2008
- Target number of participants124
- InterventionsUpper extremity CRPS-1: percutaneous blockade of Stellate ganglion at C7 with one single injection of bupivacaÔne 0,25% Lower extremity CRPS-1: percutaneous blockade of lumbar sympathetic chain at L3 with a single injection of bupivacaÔne 0,25%.
- Primary outcomePain relief in the first week after blockade as measured 3 times daily in a pain diary with 0=no pain and 10= worst imaginable pain.
- Secondary outcomeThe following predictors of pain relief after sympathetic blockade will be measured: 1. Pain intensity on a NRS scale of 0 to 10; 2. Subjective and objective skin temperature; 3. Hyper and hypoesthesia; 4. Allodynia; 5. Hyper and hypoalgesia; 6. The presence of dystonia; 7. Tremor and myoclonus.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J. Geurts
- CONTACT for SCIENTIFIC QUERIESDrs. F. Eijs, van
- Sponsor/Initiator Academic Hospital Maastricht (AZM), TREND consortium(The Dutch Consortium for research on Trauma Related Neuronal Dysfunction)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Economic Affairs
- PublicationsN/A
- Brief summaryPredictors of pain relief in sympathetic blockade for patients with CRPS-1 will be determined by a standardized evaluation of signs and symptoms in CRPS-1 patiŽnts with special attention to the existence of a warm or cold fenotype and measurements of skin temperature by means of infrared thermometry.
- Main changes (audit trail)
- RECORD4-apr-2006 - 3-jul-2006


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl