Abstract：
BACKGROUND: Spasticity is common after a stroke and is an independent risk factor for developing pain. BotulinumtoxinA injection is the treatment of choice for focal spasticity. We examined the effect of intramuscular botulinumtoxinA on pain relief in patients in routine clinical practice who were experiencing pain as a primary complaint associated with post-stroke lower limb spasticity.
METHODS: Prospective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0-10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0-100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey.
RESULTS: Of 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0-10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection.
CONCLUSIONS: BotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).
METHODS: Prospective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0-10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0-100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey.
RESULTS: Of 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0-10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection.
CONCLUSIONS: BotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).
摘要：
背景：痉挛在卒中后很常见，并且是发生疼痛的独立危险因素。肉毒杆菌毒素A注射是治疗局灶性痉挛的首选方法。我们检查了肌肉内肉毒杆菌毒素A对常规临床实践中患者疼痛缓解的影响，这些患者的疼痛是与中风后下肢痉挛相关的主要主诉。
方法：前瞻性，多中心,上市后观察性研究。研究期为16个月。主要有效性变量是四个肉毒杆菌毒素A注射周期后疼痛0-10数值评定量表相对于基线的平均变化。次要终点包括疼痛0-100视觉模拟评分的基线变化，目标达成量表,改良的Ashworth量表,10米步行测试,Penn痉挛频率量表,和36项短期健康调查。
结果：在186名患者中，180（96.8％）至少接受了一次肉毒杆菌毒素A。平均（标准差）疼痛0-10数值评定量表评分从基线时的4.9（2.2）显着降低（p<0.0001）至研究结束时的2.5（2.1），表示疼痛严重程度降低50%。除10米步行测试外，所有次要变量的基线改善都支持了由于痉挛引起的疼痛的缓解。一名患者的两个不良事件（丹毒和静脉炎）被认为可能与肉毒杆菌毒素A注射有关。
结论：肉毒杆菌毒素A似乎可以缓解疼痛，作为局部治疗中风后下肢痉挛的患者的额外益处，疼痛缓解是其主要治疗目标（《LayAbstract》见附录A）。
方法：前瞻性，多中心,上市后观察性研究。研究期为16个月。主要有效性变量是四个肉毒杆菌毒素A注射周期后疼痛0-10数值评定量表相对于基线的平均变化。次要终点包括疼痛0-100视觉模拟评分的基线变化，目标达成量表,改良的Ashworth量表,10米步行测试,Penn痉挛频率量表,和36项短期健康调查。
结果：在186名患者中，180（96.8％）至少接受了一次肉毒杆菌毒素A。平均（标准差）疼痛0-10数值评定量表评分从基线时的4.9（2.2）显着降低（p<0.0001）至研究结束时的2.5（2.1），表示疼痛严重程度降低50%。除10米步行测试外，所有次要变量的基线改善都支持了由于痉挛引起的疼痛的缓解。一名患者的两个不良事件（丹毒和静脉炎）被认为可能与肉毒杆菌毒素A注射有关。
结论：肉毒杆菌毒素A似乎可以缓解疼痛，作为局部治疗中风后下肢痉挛的患者的额外益处，疼痛缓解是其主要治疗目标（《LayAbstract》见附录A）。
