Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Trials. 2024 Jun 27;25(1):418. doi: 10.1186/s13063-024-08258-8.
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.
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.
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.
Chinese clinical Trial Registry, ChiCTR2300070132. Registered 03 April 2023, https://www.chictr.org.cn/showproj.html?proj=193722 .
偏瘫后肩部疼痛（HSP）是中风后的常见并发症。它严重影响上肢运动功能的恢复。偏瘫患者早期肩部疼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。常用的肩关节皮质类固醇注射可以减轻肩部疼痛；然而，其副作用还包括软组织退化或增加肌腱脆弱性，长期效果仍存在争议。肉毒毒素注射是一种相对较新的方法，据认为可以阻断肩关节腔内痛觉感受器的传递，并抑制致痛物质的产生，从而减轻神经原性炎症。一些研究表明，中风后偏瘫的肩部疼痛是由与肩部疼痛相关的中枢系统变化引起的，持续的疼痛可能会诱导皮质感觉中枢或运动中枢的重组。然而，关于肉毒毒素减轻疼痛是否会影响大脑功能，尚无确凿证据。在之前关于肉毒毒素与糖皮质激素（曲安奈德注射）治疗肩部疼痛的研究中，缺乏对大脑功能变化差异的观察。由于之前评估疼痛改善的内容主要是主观的，缺乏客观的定量评估指标。功能性近红外光谱成像（fNIRS）可以弥补这一问题。
本研究方案设计为一项双盲、随机对照临床试验，纳入无肱二头肌长头腱鞘炎或肩峰下滑囊炎的中风后 HSP 患者。78 名患者将被随机分配到肉毒毒素 A 组或糖皮质激素组。在基线时，每组患者将接受肩关节腔内注射肉毒毒素或糖皮质激素，并在 1 周和 4 周时进行随访。主要结局是视觉模拟量表（VAS）上肩部疼痛的变化。次要结局是通过 fNIRS 成像评估相应脑区氧合血红蛋白水平的变化、肩前屈、外旋活动范围、上肢 Fugl-Meyer 评分和改良 Ashworth 评分。
超声引导下肉毒毒素 A 肩关节腔注射可能为 HSP 患者的疼痛改善提供证据。该试验的结果还有助于分析肩部疼痛变化与大脑血液动力学和肩关节运动功能变化之间的相关性。
中国临床试验注册中心，ChiCTR2300070132。注册于 2023 年 4 月 3 日，https://www.chictr.org.cn/showproj.html?proj=193722。
