■周围神经刺激(PNS)是一种已建立的治疗外周起源的慢性神经性疼痛,通常是在神经损伤之后。然而,缺乏随机对照试验(RCT)证明PNS的治疗益处.当前研究(COMFORT研究)的目标是记录Nalu神经刺激在PNSRCT中的安全性和有效性,与传统医疗管理(CMM)相比。
■这是一个前景,多中心,RCT评价PNS治疗神经性疼痛的疗效。以下四个区域之一将成为治疗的目标:低背部,肩膀,膝盖或脚/脚踝。同意的受试者将接受基线评估,之后,他们被随机2:1(PNS+CMM臂到CMM臂)。随机分配到PNS+CMM臂的受试者将使用最佳临床实践进行试验植入期。通过试验阶段的受试者,通过显示疼痛相对于基线减少≥50%,将接受永久植入物。所有接受永久性植入物的受试者将被跟踪总共36个月。在3个月的主要终点,CMM臂中的受试者将可以选择交叉到PNS+CMM臂中,从试验植入开始。从首次招募到最后一个受试者的最后随访和随后的研究结束,研究持续时间预计为5.5年。不良事件将在整个研究中被捕获。
■舒适研究,在这里描述,有可能证明纳鲁神经刺激系统治疗周围神经病变的有效性和安全性。这项研究的结果将是第一个I级证据,到36个月,验证该PNS系统在慢性疼痛治疗中的应用。这项研究旨在招募最大的队列,到目前为止,比较PNS+CMM与单独CMM的受试者。
外周神经刺激(PNS)已被用于治疗外周起源的神经性疼痛数十年。这种治疗通常涉及在所讨论的神经附近放置小的(~1mm直径)圆柱形电极(引线)。然后向目标输送温和的电脉冲,从而阻止疼痛信号到达中枢神经系统。尽管这种方法在临床上取得了成功,很少有随机对照试验(RCT)证明PNS治疗周围神经痛/神经病变的疗效.这可能是,在很大程度上,由于缺乏足够小的PNS设备,可以在四肢和躯干的多个位置提供这种治疗。例如,大多数植入式脉冲发生器(IPG)的体积范围为14至40cm3。此RCT的目的是证明外部供电的微型IPG(体积<1.5cm3)的安全性和有效性,在递送PNS治疗周围神经性疼痛中。活动臂受试者将接受微IPG治疗,并继续使用常规医疗管理(CMM);对照臂受试者将仅接受CMM治疗。主要终点是3个月时的应答率,在双臂中,定义为植入微IPG后疼痛减轻≥50%的受试者百分比。控制臂受试者将在3个月时选择交叉到活动臂。两组研究对象均随访至36个月。
UNASSIGNED: Peripheral Nerve Stimulation (PNS) is an established therapy for chronic neuropathic pain of peripheral origin, typically following nerve injury. However, there is a paucity of Randomized Controlled Trials (RCTs) demonstrating the therapeutic benefits of PNS. The goals of the current study (COMFORT Study) are to document the safety and efficacy of the Nalu Neurostimulation in a PNS RCT, compared to conventional medical management (CMM).
UNASSIGNED: This is a prospective, multicenter, RCT evaluating the treatment of neuropathic pain with PNS therapy. One of the following four regions will be targeted for treatment: low back, shoulder, knee or foot/ankle. Consented subjects will undergo a baseline evaluation, after which they are randomized 2:1 (PNS+CMM arm to CMM arm). Subjects randomized to PNS+CMM arm will undergo a trial implant period using best clinical practices. Subjects who pass the trial phase, by showing a ≥ 50% reduction in pain relative to baseline, will receive the permanent implant. All subjects receiving a permanent implant will be followed for a total of 36 months. At the 3-month primary end point, subjects in CMM arm will be given the option to crossover into PNS+CMM arm, beginning with a trial implant. The study duration is expected to be 5.5 years from first enrollment to last follow-up of last subject and subsequent study closure. Adverse events will be captured throughout the study.
UNASSIGNED: The COMFORT study, described here, has the potential to demonstrate the efficacy and safety of the Nalu Neurostimulation System in the treatment of peripheral
neuropathy. Results of this study will be the first Level-I evidence, out to 36 months, validating the use of this PNS system in the treatment of chronic pain. This study is designed to enroll the largest cohort, to date, of subjects comparing PNS+CMM vs CMM alone.
Peripheral nerve stimulation (PNS) has been used for decades to treat neuropathic pain of peripheral origin. This therapy typically involves the placement small (~1 mm diameter) cylindrical electrodes (leads) near the nerve(s) in question, which is then followed by the delivery mild electrical pulses to the target, thereby blocking the pain signal from reaching the central nervous system. Despite the clinical success of this approach, there are few randomized controlled trials (RCTs) demonstrating PNS efficacy in the treatment of peripheral neuralgia/
neuropathy. This may be, in large part, due to a paucity of PNS devices that are small enough to deliver this therapy at multiple locations in the extremities and the torso. For example, most implantable pulse generators (IPGs) range in size from 14 to 40 cm3 in volume. The purpose of this RCT is to demonstrate the safety and efficacy of an externally powered micro-IPG (<1.5 cm3 in volume), in the delivery of PNS to treat peripheral neuropathic pain. Active Arm subjects will receive therapy with the micro-IPG and continue to use conventional medical management (CMM); Control Arm subjects will be treated with CMM only. The primary endpoint is the responder rate at 3-months, in both arms, defined as the percentage of subjects with ≥50% pain reduction from baseline following implantation of the micro-IPG. Control Arm subjects will be given the option to crossover to the Active Arm at 3-months. Study subjects in both arms are followed out to 36 months.