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

Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3877673
Email Jgeurt@sane.azm.nl

Study information

Study designNon-randomized controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titlePercutaneous sympathetic blockade in complex regional pain syndrome type 1: a prospective clinical investigation on predictors of sympatheticaly maintained pain
Study acronymSYMBLOC
Study objectivesThe 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) studiedComplex regional pain syndrome type 1 (CRPS I) (Causalgia)
InterventionUpper 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupivacaine
Primary outcome measurePain 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 measuresThe 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 date10/04/2006
Completion date10/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants124
Total final enrolment49
Key inclusion criteriaAdult (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 criteria1. 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 enrolment10/04/2006
Date of final enrolment10/04/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Hospital Maastricht (AZM)
Maastricht
6202 AZ
Netherlands

Sponsor information

Academic Hospital Maastricht (AZM) and Dutch Consortium for Research on Trauma Related Neuronal Dysfunction (TREND)
University/education

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

ROR logo "ROR" https://ror.org/02d9ce178

Funders

Funder type

Government

Ministry of Economic Affairs (BSIK03016)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.