Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A
NCT Number: NCT06470581
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complex Regional Pain Syndromes
Interventions: DRUG: Botulinum toxin A
Sponsor: Seoul National University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-04-25

Summary:
Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. The temperature of the affected arm is often lower than that of the opposite side. As a result of the procedure, the patient may experience sympathetic pain relief, such as coldness, stinging, numbness of the upper extremity. If the procedure does not last long, repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed.

However, even though in rare cases, chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion. Therefore, it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury.

Recently, it has been reported that botulinum toxin (BTX) has been successfully used for the treatment of pain disorders. BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings. Therefore, the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic. It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity. Therefore, Botulinum toxin type A (BTA) is recommended for the treatment of migraine, myofascial pain syndrome, and neuropathic pain accompanied by allodynia. This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized, double-blind, parallel group, and comparative clinical trials.

Primary Outcome Measures: The changes in average pain intensity in 4weeks, Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours, 4 weeks after procedure
Secondary Outcome Measures: The changes in average pain intensity in 12weeks, Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours, 12 weeks after procedure|The changes in maximum pain intensity, Comparison between groups of the mamimum change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours, 4 and 12 weeks after procedure|The changes in pain related to procedure, Inter- and intra-group comparison of the change in procedure-related 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable), 30 minutes after the procedure|The change in the temperature difference, the change in the relative temperature difference on the blocked palm compared with the contralateral palm, 30 minutes, 4 and 12 weeks after the procedure|Blood flow velosity, Comparison between groups of blood flow velosity at brachial artery using ultrasound, 30 minutes, 4 and 12 weeks after the procedure|Korean CISS (Cold Intolerance Symptom Severity) Questionnaire, Inter- and intra-group comparison of the change in Korean CISS score from 4 to 100 (mild, 4-25; moderate, 26-50; severe, 51-75; and extremely severe, 76-100), 4 and 12 weeks after the procedure|Paindetect questionare (PD-Q), Inter- and intra-group comparison of the change in PD-Q score from 0 to 38 (total scores of less than 12 considered to represent nociceptive pain, 13-18 possible NeP, and \>19 representing \>90% likelihood of NeP), 4 and 12 weeks after the procedure|Patient satisfaction, Patient satisfaction related to procedure using 5-pointed Likert scale (Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied), after procedure|Medication change (Opioids), Comparison between groups of change with Morphine Equivalent Daily Dose (MEDD), 4 and 12 weeks after the procedure|Additional intervention, Comparison between groups of total number of additional executed sympathetic blocks, 4 and 12 weeks after the procedure