Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.
研究概览
简要总结
The purpose of this study is to assess the efficacy of pregabalin in patients with complex regional pain syndrome Type I and to determine whether it provides clinically significant pain relief and whether it improves functioning of the upper limb.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with CRPS Type I as per the IASP (International Association for the Study of Pain) criteria which states presence of an initiating noxious event, or cause for immobilization
- •Evidence at some point of swelling, color change, hot/cold/sweaty sensation and no other condition which can account for the pain and dysfunction of the upper limb
- •Men or women between ages 18-65 year old
- •Women should not be pregnant or breast feeding
- •No change in treatment for 4 weeks prior to recruitment
- •Pain scores of 4/10 on a verbal analogue scale
排除标准
- •Patients with a neurologic disorder unrelated to CRPS
- •Patients who are already on pregabalin
- •Patients with renal impairment whose creatinine clearance is less than 60 ml/min
- •Patients with congestive heart failure who are also diabetic and taking thiazolidinedione medication like rivoglitazone
- •Unstable psychiatric history
- •Patients with another problem with equal or worse pain
- •Unstable medical condition
研究组 & 干预措施
2
Ten patients will be be in the placebo group.
干预措施: Placebo (Other)
1
Pregabalin group is made up of 20 patients. Patients will receive 150mg/day in two divided does. The patients will be assessed weekly and the dose can be increased to 300mg/day, if the patient does not report any decrease in pain. The following week the dose may be increased to 600mg/day if once again the patient reports no decrease in pain. This is also the maximum permissible does that will be given to the patient. If patient reports any side effects then the dose can be decreased once. The time period of 2 to 5 weeks will be the dose adjustment period. After which the drug maintenance period extends from week 5 to 12. All doses will be given in two divided doses/day.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.
时间窗: Three months
次要结局
- Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.(Three months)