Electrical Stimulation for Hemiplegic Shoulder Pain

电刺激治疗偏瘫肩痛

• 批准号: 7936233
• 负责人: John Chae
• 金额: $ 34.94万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936233
• 关键词: 3-Dimensional; Activities of Daily Living; Address; Affect; Brief Pain Inventory; Characteristics; Clinical; Clinical Skills; Clinical Trials; Communities; Cutaneous; Development; Effectiveness; Electric Stimulation; Electrodes; Ensure; Family; Fatigue; Frequencies; Functional disorder; Health; Human Resources; Implanted Electrodes; Intervention; Intramuscular; Joints; Knowledge; Lead; Measures; Motor; Muscle; Muscle Contraction; Muscle Fatigue; Muscle Hypertonia; Pain; Patient Education; Patients; Procedures; Quality of life; Randomized Clinical Trials; Recovery; Rehabilitation Outcome; Rehabilitation therapy; Relative (related person); Research Personnel; Risk; Schedule; Shoulder; Shoulder Pain; Stroke; Surface; Survivors; System; Therapeutic; Time; Treatment Protocols; Upper Extremity; arm; base; caregiving; clinical practice; clinically relevant; comparative effectiveness; compare effectiveness; compliance behavior; cost; design; effectiveness trial; health related quality of life; hemiparesis; improved; minimally invasive; motor impairment; novel; pain receptor; post stroke; pragmatic trial; success; treatment as usual; treatment effect

Post-stroke shoulder pain is a major rehabilitation problem affecting up to 60% of moderate to severely impaired stroke survivors.1 Post-stroke shoulder pain is associated with poor rehabilitation outcomes, including impaired activities of daily living2 and poor quality of life (QOL).3 Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder is the only intervention with evidence of efficacy from multiple randomized clinical trials (RCT).4-6 Despite the evidence for therapeutic benefit, the clinical implementation of surface ES for post-stroke shoulder pain has been difficult for several reasons. First, stimulation of cutaneous pain receptors cannot be avoided. While some stroke survivors are able to tolerate one or 2-hrs of daily surface ES therapy, many are not able to tolerate the required 6-hrs. Second, in order to minimize the stimulation-induced pain, ES is delivered at a relatively high frequency between 20 and 35 Hz, which can lead to more rapid onset of muscle fatigue.7 Third, due to stimulation-induced pain and muscle fatigue, an escalating stimulation schedule is needed. Finally, clinical skill or intensive patient training is required to reliably place electrodes on a daily basis and adjust stimulation parameters to provide optimal and tolerable treatment with minimal muscle fatigue. Accordingly, Baker and Parker, the authors of the first clinical trial of surface ES for post-stroke shoulder dysfunction, concluded “Until implanted electrode systems become available… long-term use of surface electrical stimulation can be managed by only a few patients… and their families.”8(p1937) In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain.9-14 Since electrodes are implanted into motor points, skilled personnel and intense patient training are not needed to ensure proper placement of electrodes for each treatment session.10, 12, 15 IM ES is less painful and better tolerated then surface ES.13, 16 Therefore, IM ES can be delivered at a lower stimulation frequency, which is associated with reduced muscle fatigue.7 The reduced pain and fatigue of IM ES obviate the need for a cumbersome escalating stimulation schedule. Accordingly, the ES and muscle contraction are reliable and there is strong patient adherence to treatment regimen.14 The investigative team completed a RCT that demonstrated the efficacy of IM ES in reducing post-stroke shoulder pain in comparison to a sling.11, 14 Post-hoc analysis further identified time from stroke onset (<18-mo) as an important predictor of treatment success.9 The initial efficacy of IM ES has been demonstrated. However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed. 1) To date, IM ES has only been compared to a sling. It has not been compared to “usual care.” 2) The investigators’ RCT showed improvements in pain related QOL based on Brief Pain Inventory (BPI) question 23; however, while this measure has been validated as a component of the BPI battery, it has not been validated as a measure of QOL. 3) The mechanism of action of IM ES in reducing shoulder pain has not been rigorously evaluated. In order to begin addressing these issues, the proposed study is designed as a comparative effectiveness single-blinded exploratory RCT. The primary objective is to estimate the relative effect sizes of pain reduction associated with IM ES and “usual care.” Given the added costs and risks of a minimally invasive procedure, the superiority of IM ES over “usual care” needs to be demonstrated. We will use these estimates to design and power a larger effectiveness trial. The secondary objective is to evaluate the impact of pain reduction on quality of life. Demonstration of improvement in quality of life will validate the clinical relevance of the intervention. Finally, we will explore mechanisms. The elucidation of mechanisms will further guide the refinement of the interventions. We postulate that ES reduces shoulder pain by improving glenohumeral stability. Thus we will evaluate the relative effects of these treatments on 3-dimensional stiffness characteristics of the glenohumeral joint. We further postulate that ES improves glenohumeral stability by facilitating motor recovery. Thus we will evaluate the effects of these treatments on objective measures of poststroke motor recovery.

卒中后肩痛是一个主要的康复问题，影响高达60%的中度至重度受损卒中幸存者。1卒中后肩痛与不良康复结局相关，包括日常生活活动受损2和生活质量（QOL）差。3表面电刺激（ES）对偏瘫肩周围肌肉的治疗是唯一有多项随机临床试验（RCT）证据证明有效的干预措施。4 -6 尽管有治疗益处的证据，但由于几个原因，表面ES用于中风后肩痛的临床实施一直很困难。首先，皮肤疼痛感受器的刺激是不可避免的。虽然一些中风幸存者能够耐受每天1或2小时的表面ES治疗，但许多人不能耐受所需的6小时。其次，为了最大限度地减少刺激引起的疼痛，ES以20至35 Hz之间的相对较高的频率输送，这可能导致肌肉疲劳更快地发作。7第三，由于刺激引起的疼痛和肌肉疲劳，需要逐步增加刺激时间表。最后，需要临床技能或密集的患者培训，以每天可靠地放置电极并调整刺激参数，以提供最佳和可耐受的治疗，同时最大限度地减少肌肉疲劳。 因此，Baker和帕克（第一次表面电刺激治疗卒中后肩关节功能障碍临床试验的作者）得出结论：“在植入式电极系统可用之前. 8（p1937） 为了解决表面ES的局限性，研究小组率先开发了经皮肌内（IM）ES，用于治疗中风后肩痛。9 -14由于电极植入运动点，因此不需要熟练的人员和高强度的患者培训来确保每次治疗过程中电极的正确放置。10，12，15 IM ES比表面ES疼痛更轻，耐受性更好。13，16因此，IM ES可以以较低的刺激频率输送，这与以下因素相关： 减少肌肉疲劳。7 IM ES减少的疼痛和疲劳消除了对繁琐的逐步增加的刺激时间表的需要。因此，ES和肌肉收缩是可靠的，并且患者对治疗方案有很强的依从性。14研究小组完成了一项RCT，证明了IM ES与吊带相比在减少卒中后肩痛方面的疗效。11，14事后分析进一步确定了卒中发作时间（<18个月）是治疗成功的重要预测因素。9 IM ES的初步疗效已得到证实。然而，在临床界接受之前，需要解决科学和临床知识方面的其他差距。1)到目前为止，IM ES仅与吊带进行比较。它还没有被比作“常规护理”。2)研究者的随机对照试验 基于简明疼痛量表（BPI）问题23，显示疼痛相关QOL改善;然而，虽然该指标已被确认为BPI组合的一个组成部分，但尚未被确认为QOL指标。3)IM ES减轻肩痛的作用机制尚未得到严格评价。 为了开始解决这些问题，拟定的研究设计为比较有效性的单盲探索性RCT。主要目的是估计IM ES和“常规护理”相关疼痛减轻的相对效应量。考虑到最低限度的成本和风险， 对于侵入性手术，需要证明IM ES优于“常规护理”。我们将使用这些估计值来设计和支持更大的有效性试验。次要目的是评价疼痛减轻对生活质量的影响。生活质量改善的证明将验证干预的临床相关性。最后，我们将探讨机制。对机制的阐明将进一步指导干预措施的完善。我们假设ES通过改善肩部疼痛来减轻肩部疼痛 盂肱稳定性因此，我们将评估这些治疗对盂肱关节三维刚度特征的相对影响。我们进一步假设ES通过促进运动恢复来改善盂肱关节的稳定性。因此，我们将评估这些治疗对中风后运动恢复的客观测量的影响。