■慢性下腰痛(CLBP)通常与中枢神经系统致敏的临床证据有关,找到明确的伤害性输入源可能具有挑战性。针对周围脊柱疼痛结构的常规疗法可能无法解决中央介导的问题,疼痛的根本原因。60天经皮周围神经刺激(PNS)应用于腰内侧支神经是一种非手术,非阿片类药物治疗可以恢复中枢神经系统外周输入的平衡,并逆转中枢疼痛处理的适应不良变化。作为一种微创,无损处理,经皮PNS被设计为比射频消融或永久性植入式神经刺激系统更早用于连续治疗.
■这项临床试验的目的是在一项前瞻性多中心病例系列研究中描述对内侧分支PNS的反应的持久性,该研究涉及CLBP患者对多种非手术治疗的顽固性。
■预期,多中心临床试验。
■患有CLBP的无神经根性腿痛的成年人,先前在多种常规治疗中失败。
■60天经皮PNS应用于腰内侧支神经。
■在图像引导(超声和/或透视)下植入经皮PNS导线,并进行长达60天的治疗,之后,引线被移除。参与者随访14个月(PNS治疗2个月后12个月)。前瞻性定义的终点包括疼痛强度的评估,残疾,疼痛干扰,与健康相关的生活质量,抑郁症,和病人对变化的全球印象。
■用60天经皮PNS治疗CLBP在平均疼痛强度方面产生了有临床意义的改善,残疾,和/或在整个14个月的随访期间对大多数参与者造成疼痛干扰,而不需要永久性系统植入。在至少一种结果(疼痛加剧,残疾,2个月后PNS的疼痛干扰)为91%,5个月时79%,73%在8个月,11个月时的75%,14个月时为77%。没有严重或意外的研究相关不良事件。
■这项前瞻性多中心临床试验证明了经皮PNS应用于内侧支神经治疗慢性下腰痛的临床实用性。鉴于经皮PNS的微创性质和参与者所经历的显著益处,经皮PNS为CLBP患者提供了一种安全有效的一线神经调节治疗方法,可以避免需要进行神经消融手术或永久性神经刺激系统植入.
UNASSIGNED: Chronic low back pain (CLBP) is often associated with clinical evidence of central nervous system sensitization and finding a clear source of nociceptive input can be challenging. Conventional therapies targeting peripheral spinal pain structures can fail to address centrally-mediated, underlying causes of pain. Sixty-day percutaneous peripheral nerve stimulation (PNS) applied to the lumbar medial branch nerves is a non-surgical, non-opioid treatment that may restore the balance of peripheral inputs to the central nervous system and reverse maladaptive changes in central pain processing. As a minimally invasive, non-destructive treatment, percutaneous PNS was designed to be used earlier in the treatment continuum than radiofrequency ablation or permanently-implanted neurostimulation systems.
UNASSIGNED: The objective of this clinical trial was to characterize the durability of responses to medial branch PNS in a prospective multicenter case series study of CLBP patients recalcitrant to multiple non-surgical treatments.
UNASSIGNED: Prospective, multicenter clinical trial.
UNASSIGNED: Adults with CLBP without radicular leg pain who had previously failed multiple types of conventional treatments.
UNASSIGNED: Sixty-day percutaneous PNS applied to the lumbar medial branch nerves.
UNASSIGNED: Percutaneous PNS leads were implanted under image guidance (ultrasound and/or fluoroscopy) and treatment was applied for up to 60 days, after which the leads were removed. Participants were followed through 14 months (12 months after the 2-month PNS treatment). Prospectively-defined endpoints included assessments of pain intensity, disability, pain interference, health-related quality of life, depression, and patient global impression of change.
UNASSIGNED: Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain interference for a majority of participants through the entire 14 month follow up period without requiring permanent system implantation. The proportion of participants experiencing clinically meaningful improvement in at least one outcome (pain intensiy, disability, pain interference) with PNS was 91% after 2 months, 79% at 5 months, 73% at 8 months, 75% at 11 months, and 77% at 14 months. There were no serious or unanticipated study-related adverse events.
UNASSIGNED: This prospective multicenter clinical trial demonstrates the clinical utility of percutaneous PNS when applied to the medial branch nerves for the treatment of chronic low back pain recalcitrant to non-surgical treatments. Given the minimally invasive nature of percutaneous PNS and the significant benefits experienced by participants, percutaneous PNS provides a safe and effective first-line neuromodulation treatment for patients with CLBP that may obviate the need for neuroablative procedures or permanent neurostimulation system implantation.