Brændvik Siri Merete, Ross Raftemo Anne Elisabeth, Roeleveld Karin, Andersen Guro Lillemoen, Ramstad Kjersti, Follestad Turid, Aarli Ånen, Bonikowski Marcin, Vik Torstein
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
Rehabilitation Clinic, St. Olavs University Hospital, Trondheim, Norway.
Dev Med Child Neurol. 2025 Feb;67(2):263-271. doi: 10.1111/dmcn.16038. Epub 2024 Jul 26.
To assess the effect of single botulinum neurotoxin A (BoNT-A) injections into the calf muscles on the gross energy cost of walking in children with cerebral palsy (CP) and to evaluate the effect of BoNT-A on walking capacity, physical activity, perceived changes in mobility, and pain.
This was an industry-independent, randomized, quadruple-blind, placebo-controlled, multicentre trial (ClinicalTrials.gov registration: NCT02546999). Sixty-one children (33 male, median age [range] = 8 years [4-16 years]) with spastic CP and classified in Gross Motor Function Classification System (GMFCS) levels I and II allocated to single injections of either BoNT-A or 0.9% saline into the calf muscles. The main outcome was gross energy cost (J/kg/m); secondary outcomes were walking capacity, habitual physical activity, perceived change in mobility tasks, and calf pain at baseline, 4 weeks (P1), 12 weeks (P2), and 24 weeks (P3) after the injection.
The mean change in energy cost did not differ significantly between groups at the primary time point P2 (-0.27 J/kg/m, 95% confidence interval - 0.91 to 0.36, p = 0.404), nor at P1 or P3. Regarding the secondary outcomes, there was some evidence of a larger reduction in pain intensity in the group given BoNT-A (p = 0.043).
One treatment with BoNT-A was not superior to placebo in making walking easier in children with CP classified in GMFCS levels I and II, at least in the short term. BoNT-A may have a pain-reducing effect.
评估向小腿肌肉单次注射A型肉毒杆菌神经毒素（BoNT-A）对脑瘫（CP）患儿行走总能量消耗的影响，并评估BoNT-A对行走能力、身体活动、可感知的运动变化及疼痛的影响。
这是一项非行业赞助的随机、四重盲法、安慰剂对照、多中心试验（ClinicalTrials.gov注册号：NCT02546999）。61名痉挛型CP患儿（33名男性，中位年龄[范围]=8岁[4-16岁]），根据粗大运动功能分类系统（GMFCS）分为I级和II级，被分配接受向小腿肌肉单次注射BoNT-A或0.9%生理盐水。主要结局指标为总能量消耗（焦耳/千克/米）；次要结局指标为行走能力、日常身体活动、可感知的运动任务变化以及注射后基线、4周（P1）、12周（P2）和24周（P3）时的小腿疼痛。
在主要时间点P2时，两组间能量消耗的平均变化无显著差异（-0.27焦耳/千克/米，95%置信区间-0.91至0.36，p=0.404），P1或P3时亦是如此。关于次要结局指标，有证据表明接受BoNT-A治疗的组疼痛强度降低幅度更大（p=0.043）。
至少在短期内，对于GMFCS I级和II级的CP患儿，单次BoNT-A治疗在使行走更轻松方面并不优于安慰剂。BoNT-A可能具有减轻疼痛的作用。
