Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A

Launched by SEOUL NATIONAL UNIVERSITY · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with complex regional pain syndrome (CRPS), a condition that can cause severe pain and temperature changes in one arm. The researchers are testing a procedure called a thoracic sympathetic ganglion block, where a special substance called botulinum toxin type A (BTA) is injected to block pain signals. This study aims to find out if using BTA can provide longer-lasting pain relief compared to traditional methods, which typically use local anesthetics.

To participate in this trial, individuals must be between 19 and 80 years old and have a diagnosed CRPS affecting one arm, with a pain score of 4 or higher on a scale of 0 to 10. Participants will receive the treatment and be monitored for its effectiveness. It's important to note that people with certain health conditions or who are pregnant cannot participate. If you or someone you know is dealing with ongoing pain in an arm, this study might provide an opportunity for relief while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. aged 19-80 years
• • 2. Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
• • 3. 11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
• • 4. Temperature increase at diagnostic thoracic sympathetic ganglion block
• • 5. Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration
• Exclusion Criteria:
• • 1. Refusal of the patient
• • 2. Vascular disease at upper extremity
• • 3. previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
• • 4. coagulopathy
• • 5. systemic infection or local infection at thoracic puncture site
• • 6. significant deformity at thoracic spine
• • 7. neoplasm
• • 8. known allergic reaction with amide type local anesthetics
• • 9. cognitive dysfunction (not understanding of numerical-rating-scale)
• • 10. known allergic reaction with botulinum toxin
• • 11. pregnant or feeding women
• • 12. If the patient has participated in another clinical trial within 30 days before screening, or if passed no longer than 5-fold half-life of the clinical trial drug of the participating clinical trial