Lim Jae-Young, Koh Jae-Hyeon, Paik Nam-Jong
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, South Korea.
Stroke. 2008 Jan;39(1):126-31. doi: 10.1161/STROKEAHA.107.484048. Epub 2007 Nov 29.
Shoulder pain is frequent after stroke and interferes with the rehabilitative process and outcome. However, treatments used for hemiplegic shoulder pain are limited and largely ineffective. This prospective, randomized, double-blind controlled study was conducted to compare the efficacies of botulinum toxin type A (BoNT-A) and triamcinolone acetonide (TA) on hemiplegic shoulder pain and their effects on arm function in patients with stroke.
Twenty-nine hemiplegic stroke patients with shoulder pain (duration <or=24 months, pain on numeric rating scale >or=6/10) were randomized into 2 groups. One group received intramuscular injections of BoNT-A (BOTOX 100 U total) during one session to the infraspinatus, pectoralis and subscapularis muscles in conjunction with an intraarticular injection of normal saline to painful shoulder joint, whereas the other group received an intraarticular injection of TA (40 mg) and an intramuscular injection of normal saline to the same muscles. Outcome measures were pain (measured using a numeric rating scale), physician's global rating scale, shoulder range of motion (ROM) in 4 directions, arm function measured using Fugl-Meyer score, and spasticity measured using the modified Ashworth scale. Measurements were made at baseline and 2, 6, and 12 weeks after injection.
At 12 weeks after treatment mean decrease in pain was 4.2 in the BoNT-A-treated group versus 2.5 in the TA-treated group (P=0.051), and improvements in overall ROM were 82.9 degrees versus 51.8 degrees in these groups (P=0.059), showing a strong trend toward there being less pain and better ROM among those treated with BoNT-A than with TA. However, no significant differences were observed between the 2 groups in terms of improvement in physician global rating, Fugl-Meyer score or modified Ashworth scales. No adverse effect was observed in either group.
Results from this study suggest that injection of BoNT-A into selected muscles of the shoulder girdle might provide more pain relief and ROM improvement than intraarticular steroid in patients with hemiplegic shoulder pain. A larger clinical trial needs to be undertaken to confirm the benefits of this approach.
中风后肩部疼痛很常见，会干扰康复进程和结果。然而，用于偏瘫性肩部疼痛的治疗方法有限且大多无效。本前瞻性、随机、双盲对照研究旨在比较A型肉毒毒素（BoNT-A）和曲安奈德（TA）对偏瘫性肩部疼痛的疗效及其对中风患者手臂功能的影响。
29例伴有肩部疼痛的偏瘫中风患者（病程≤24个月，数字评分量表疼痛评分≥6/10）被随机分为两组。一组在一次治疗中接受BoNT-A（总量100 U）肌肉注射至冈下肌、胸大肌和肩胛下肌，同时向疼痛的肩关节内注射生理盐水；另一组则向相同肌肉内注射TA（40 mg）并向相同肌肉内注射生理盐水。观察指标包括疼痛（采用数字评分量表测量）、医生整体评分量表、肩部四个方向的活动范围（ROM）、采用Fugl-Meyer评分测量的手臂功能以及采用改良Ashworth量表测量的痉挛程度。在基线时以及注射后2周、6周和12周进行测量。
治疗12周后，BoNT-A治疗组疼痛平均减轻4.2分，而TA治疗组为2.5分（P = 0.051），两组总体ROM改善分别为82.9度和51.8度（P = 0.059），显示出BoNT-A治疗组比TA治疗组疼痛减轻且ROM改善更明显的强烈趋势。然而，两组在医生整体评分、Fugl-Meyer评分或改良Ashworth量表的改善方面未观察到显著差异。两组均未观察到不良反应。
本研究结果表明，对于偏瘫性肩部疼痛患者，向肩胛带选定肌肉注射BoNT-A可能比关节内注射类固醇提供更多的疼痛缓解和ROM改善。需要进行更大规模的临床试验来证实这种方法的益处。
