Background and Purpose:This study aimed to assess the efficacy of an ultrasound-guided lateral approach for BoNT-A (botulinum toxin A) injections into the subscapularis in patients with hemiplegic shoulder pain.Methods:This single-center trial used a randomized, double-blind, placebo-controlled design. The key inclusion criteria were a visual analogue scale score of ≥4 cm and a modified Ashworth scale score of ≥1+. The patients were randomized to receive either BoNT-A injections or a placebo. The outcomes included the visual analogue scale score, modified Ashworth scale score, pain-free passive range of motion of the hemiplegic shoulder, Fugl-Meyer assessment score for the upper extremities, and Stroke-Specific Quality-of-Life score.Results:A total of 49 hemiplegic shoulder pain patients were screened, and 36 were included. The participants receiving the BoNT-A injection reported a significant decrease in pain (visual analogue scale, −1.39 [95% CI, −2.41 to −0.36]; P=0.002) and spasticity (modified Ashworth scale score for shoulder internal rotation, −0.72 [95% CI, −1.10 to −0.35]; P=0.001; modified Ashworth scale score for shoulder abduction, −0.44 [95% CI, −0.90 to −0.01]; P=0.026) and improved pain-free passive shoulder internal rotation range of motion (14.56 [95% CI, 6.70–21.41]; P<0.001) and quality of life (Stroke-Specific Quality-of-Life upper extremity subscale, P=0.025) compared with those receiving the placebo at the end point. The shoulder abduction range of motion did not significantly improve after the BoNT-A injection at the end point (P=0.127). In addition, the patients in the BoNT-A group showed significant improvements in the visual analogue scale score and shoulder external rotation range of motion at the 12-week follow-up. No injection-related adverse events were observed during or after the interventions in either group.Conclusions:The ultrasound-guided lateral approach for BoNT-A injections into the subscapularis is a precise and reliable method for reducing pain and spasticity and improving quality of life in stroke survivors with hemiplegic shoulder pain.Registration:URL: https://www.chictr.org.cn; Unique identifier: ChiCTR1900023513.

中文翻译：

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超声引导下将 BoNT-A（肉毒杆菌毒素 A）注射到肩胛下肌治疗偏瘫肩痛：一项随机、双盲、安慰剂对照试验

背景和目的：本研究旨在评估超声引导外侧入路对偏瘫肩痛患者肩胛下肌注射肉毒毒素 A（A 型肉毒杆菌毒素）的疗效。方法：本单中心试验采用随机、双-盲法、安慰剂对照设计。关键的纳入标准是≥4 cm 的视觉模拟评分和≥1+ 的改良 Ashworth 评分。患者被随机分配接受 BoNT-A 注射或安慰剂。结果包括视觉模拟评分、改良 Ashworth 评分、偏瘫肩无痛被动活动范围、上肢 Fugl-Meyer 评估评分和中风特异性生活质量评分。 结果：A共筛查偏瘫肩痛患者49例，纳入36例。P = 0.002）和痉挛状态（肩内旋的改良 Ashworth 量表评分，-0.72 [95% CI，-1.10 至 -0.35]；P = 0.001；肩外展的改良 Ashworth 量表评分，-0.44 [95% CI，- 0.90 至 -0.01]；P = 0.026）和改善无痛被动肩关节内旋运动范围（14.56 [95% CI，6.70-21.41]；P <0.001）和生活质量（卒中特异性质量-生命上肢分量表，P = 0.025）与在终点接受安慰剂的人相比。终点 BoNT-A 注射后肩外展活动度没有明显改善（P=0.127）。此外，在 12 周的随访中，BoNT-A 组患者的视觉模拟评分和肩关节外旋活动度均有显着改善。两组在干预期间或干预后均未观察到与注射相关的不良事件。结论：肩胛下肌肉毒毒素（BoNT-A）注射超声引导外侧入路是减轻疼痛和痉挛、提高生活质量的精确可靠方法。患有偏瘫肩痛的中风幸存者。注册：网址：https://www.chictr.org.cn；唯一标识符：ChiCTR1900023513。