An interventional study of Botulinum toxin A in Complex Regional Pain Syndromes, sponsored by Seoul National University. Not yet recruiting. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Seoul National University · Not applicable, Interventional, and Treatment
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.
205 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 78 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
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Total volume of 0.375% ropivacaine 3 mL will be injected in phase 2.
Drug: Botulinum toxin A
Total volume of BTX-A 75U in normal saline 3ml will be injected in phase 2.
Drug: Botulinum toxin A
Patients were assigned 1:1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In Phase 1, the needle is inserted near the vertebrae T3 under fluoroscopic guidance. An 1 ml of non-ionized contrast medium is injected to evaluate the diffusion pattern, and 3ml of 0.75% ropivacaine is injected. After identifying a temperature increase in the ipsilateral palm within 20 min in the operating room with the prone position, 3 ml of 0.375% ropivacaine and botulinum toxin type A 75 IU mixed with 3 ml of non-preserved saline solution are injected in the patients in the control and botulinum toxin groups, respectively.
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
Time frame: 4 weeks after procedure
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 30 minutes, 4 and 12 weeks after the procedure
Blood flow velosity
Comparison between groups of blood flow velosity at brachial artery using ultrasound
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: after procedure
Medication change (Opioids)
Comparison between groups of change with Morphine Equivalent Daily Dose (MEDD)
Time frame: 4 and 12 weeks after the procedure
Additional intervention
Comparison between groups of total number of additional executed sympathetic blocks
Time frame: 4 and 12 weeks after the procedure
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Complex Regional Pain Syndromes →
Seoul National University