背景:偏瘫肩痛(HSP)是中风后常见的并发症。严重影响上肢运动功能的恢复。偏瘫患者早期肩痛主要是由中枢神经损伤或神经可塑性引起的神经性疼痛。在肩关节中常用的皮质类固醇注射可以减轻肩痛;然而,副作用还包括软组织退化或肌腱脆性增加,长期影响仍然存在争议。肉毒杆菌毒素注射相对较新,被认为可以阻断肩关节腔中疼痛受体的传递,并抑制神经致病物质的产生,以减少神经源性炎症。有研究认为,中风后偏瘫的肩痛是由与肩关节疼痛有关的中枢系统改变引起的,持续性疼痛可能导致皮质感觉中枢或运动中枢的重组。然而,目前尚无确凿的证据表明肉毒杆菌毒素对疼痛的改善是否会影响脑功能。在以前的研究中,肉毒杆菌毒素与糖皮质激素(曲安奈德注射液)治疗肩痛,缺乏观察大脑功能变化的差异。由于以前评估疼痛改善的内容主要是主观的,缺乏客观量化的考核指标。功能性近红外成像(fNIRS)可以解决这个问题。
方法:本研究方案是为双盲,无肱二头肌长腱鞘炎或肩峰滑囊炎的卒中后HSP患者的随机对照临床试验。78名患者将被随机分配到A型肉毒杆菌毒素组或糖皮质激素组。在基线,每组患者将接受肩部腔注射肉毒杆菌毒素或糖皮质激素,随访1周和4周.主要结果是视觉模拟量表(VAS)上的肩痛变化。次要结果是通过fNIRS成像评估相应脑区的氧合血红蛋白水平变化,肩部屈曲,外部旋转运动范围,上肢Fugl-Meyer,并修改了Ashworth分数。
结论:超声引导下A型肉毒杆菌毒素肩关节腔注射可能为HSP患者疼痛改善提供证据。这项试验的结果也有助于分析肩痛的变化与脑血流动力学和肩关节运动功能变化之间的相关性。
背景:中国临床试验注册,ChiCTR2300070132。2023年4月3日注册,https://www。chictr.org.cn/showproj.html?proj=193722。
BACKGROUND: Hemiplegic shoulder pain (HSP) is a common complication after stroke. It severely affects the recovery of upper limb motor function. Early shoulder pain in hemiplegic patients is mainly neuropathic caused by central nerve injury or neuroplasticity. Commonly used corticosteroid injections in the shoulder joint can reduce shoulder pain; however, the side effects also include soft tissue degeneration or increased tendon fragility, and the long-term effects remain controversial. Botulinum toxin injections are relatively new and are thought to block the transmission of pain receptors in the shoulder joint cavity and inhibit the production of neuropathogenic substances to reduce neurogenic inflammation. Some studies suggest that the shoulder pain of hemiplegia after stroke is caused by changes in the central system related to shoulder joint pain, and persistent pain may induce the reorganization of the cortical sensory center or motor center. However, there is no conclusive evidence as to whether or not the amelioration of pain by botulinum toxin affects brain function. In previous studies of botulinum toxin versus glucocorticoids (triamcinolone acetonide injection) in the treatment of shoulder pain, there is a lack of observation of differences in changes in brain function. As the content of previous assessments of pain improvement was predominantly subjective, objective quantitative assessment indicators were lacking. Functional near-infrared imaging (fNIRS) can remedy this problem.
METHODS: This study protocol is designed for a double-blind, randomized controlled clinical trial of patients with post-stroke HSP without biceps longus tenosynovitis or acromion bursitis. Seventy-eight patients will be randomly assigned to either the botulinum toxin type A or glucocorticoid group. At baseline, patients in each group will receive shoulder cavity injections of either botulinum toxin or glucocorticoids and will be followed for 1 and 4 weeks. The primary outcome is change in shoulder pain on the visual analog scale (VAS). The secondary outcome is the assessment of changes in oxyhemoglobin levels in the corresponding brain regions by fNIRS imaging, shoulder flexion, external rotation range of motion, upper extremity Fugl-Meyer, and modified Ashworth score.
CONCLUSIONS: Ultrasound-guided botulinum toxin type A shoulder joint cavity injections may provide evidence of pain improvement in patients with HSP. The results of this trial are also help to analyze the correlation between changes in shoulder pain and changes in cerebral hemodynamics and shoulder joint motor function.
BACKGROUND: Chinese clinical Trial Registry, ChiCTR2300070132. Registered 03 April 2023, https://www.chictr.org.cn/showproj.html?proj=193722 .