Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome: A Prospective Randomized, Double-blind, and Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 主要终点
- The changes in average pain intensity in 4weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 19-80 years
- •Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
- •11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
- •Temperature increase at diagnostic thoracic sympathetic ganglion block
- •Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration
排除标准
- •Refusal of the patient
- •Vascular disease at upper extremity
- •previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
- •coagulopathy
- •systemic infection or local infection at thoracic puncture site
- •significant deformity at thoracic spine
- •known allergic reaction with amide type local anesthetics
- •cognitive dysfunction (not understanding of numerical-rating-scale)
- •known allergic reaction with botulinum toxin
- •pregnant or feeding women
- •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
研究组 & 干预措施
Local anesthetics
Total volume of 0.375% ropivacaine 3 mL will be injected in phase 2.
干预措施: Botulinum toxin A (Drug)
Botulinum toxin A
Total volume of BTX-A 75U in normal saline 3ml will be injected in phase 2.
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
The changes in average pain intensity in 4weeks
时间窗: 4 weeks after procedure
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
次要结局
- The changes in pain related to procedure(30 minutes after the procedure)
- Blood flow velosity(30 minutes, 4 and 12 weeks after the procedure)
- Korean CISS (Cold Intolerance Symptom Severity) Questionnaire(4 and 12 weeks after the procedure)
- Patient satisfaction(after procedure)
- Additional intervention(4 and 12 weeks after the procedure)
- The change in the temperature difference(30 minutes, 4 and 12 weeks after the procedure)
- Paindetect questionare (PD-Q)(4 and 12 weeks after the procedure)
- Medication change (Opioids)(4 and 12 weeks after the procedure)
- The changes in average pain intensity in 12weeks(12 weeks after procedure)
- The changes in maximum pain intensity(4 and 12 weeks after procedure)
研究者
Jeeyoun Moon
Professor
Seoul National University