Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial.
Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial.
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DOI：
10.1136/bmjopen-2017-021039
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发表时间：
2018-07-16
期刊：
影响因子：
2.9
通讯作者：
Ortiz-Catalan M
中科院分区：
文献类型：
--
作者：
Lendaro E;Hermansson L;Burger H;Van der Sluis CK;McGuire BE;Pilch M;Bunketorp-Käll L;Kulbacka-Ortiz K;Rignér I;Stockselius A;Gudmundson L;Widehammar C;Hill W;Geers S;Ortiz-Catalan M
幻肢痛(PLP)是一种慢性疾病，会极大地降低生活质量。对幻肢的控制和这种控制的锻炼被认为可以逆转与PLP相关的适应不良的大脑变化。初步研究表明，使用肌电模式识别对运动意志进行解码，同时通过虚拟和增强现实(VR-AR)提供实时反馈，可以促进幻觉运动执行(PME)并减少PLP。在这里，我们提出了一项国际(7个国家)、多中心(9家诊所)、双盲、随机对照临床试验的研究方案，以评估PME在缓解PLP方面的有效性。67名患有上肢或下肢PLP的患者被随机分配到PME或幻影运动想象(PMI)干预组。被分配到任何一种治疗的受试者都会接受15次干预，并使用相同的设备暴露在相同的VR-AR环境中。干预之间的唯一区别是幻影运动是实际执行的(PME)还是只是想象的(PMI)。在基线和干预完成时以及1、3和6个月后使用意向治疗(ITT)方法进行完整的评估。在第一个疗程和最后一个疗程之间，使用疼痛评级指数测量的PLP的变化是疗效的主要衡量标准。次要结果包括：疼痛的频率、持续时间、疼痛质量、疼痛对日常生活和睡眠活动的侵扰、与疼痛相关的残疾、疼痛自我效能、抑郁情绪的频率、灾难性思维的存在、与健康相关的生活质量以及作为患者自己印象的临床显著变化。随访访谈在治疗后6个月内进行。这项研究是根据《赫尔辛基宣言》进行的，并得到每个参与诊所的管理伦理委员会的批准。结果将根据报告试验的综合标准指南在同行评议的期刊上发表。NCT03112928；预告。
Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment. The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal. NCT03112928; Pre-results.
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