Condition category
Nervous System Diseases
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
03/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

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

Sponsor information

Organisation

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

Sponsor details

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Sponsor type

University/education

Website

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes