Contact information
Type
Scientific
Primary contact
Dr J. Geurts
ORCID ID
Contact details
Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3877673
Jgeurt@sane.azm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BSIK03016
Study information
Scientific title
Percutaneous sympathetic blockade in complex regional pain syndrome type 1: a prospective clinical investigation on predictors of sympatheticaly maintained pain
Acronym
SYMBLOC
Study hypothesis
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
Not provided at time of registration
Study design
Non-randomized controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
10/04/2006
Overall trial end date
10/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Total final enrolment
49
Participant 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
Recruitment start date
10/04/2006
Recruitment end date
10/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Hospital Maastricht (AZM)
Maastricht
6202 AZ
Netherlands
Funders
Funder type
Government
Funder name
Ministry of Economic Affairs (BSIK03016)
Alternative name(s)
Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
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
Basic results (scientific)
Publication list
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22143169 (added 02/05/2019)