Restorative neurostimulation for chronic mechanical low back pain - Three year results from the United Kingdom post market clinical follow-up registry.

IF 1.3 Q4 CLINICAL NEUROLOGY

British Journal of Pain Pub Date : 2023-10-01 Epub Date: 2023-06-06 DOI:10.1177/20494637231181498

Simon Thomson, Adam Williams, Girish Vajramani, Manohar Sharma, Sarah Love-Jones, Rajiv Chawla, Sam Eldabe

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引用次数: 0

Abstract

Introduction: Mechanical chronic low back pain is often associated with impaired neuromuscular control of the lumbar multifidus muscles, the most important stabilizers of the lumbar spine. Restorative neurostimulation is a modality for the treatment for this specific subset of patients aimed to facilitate restoration of neuromuscular control by bilateral stimulation of the L2 medial branches. Evidence from both prospective and randomised clinical trials to date has demonstrated substantial improvements in clinical outcomes such as pain, disability and health-related quality of life.

Methods: This study is an open label prospective follow-up for the treatment of chronic mechanical low back pain of nociceptive origin with restorative neurostimulation. Patients completed assessments for pain, disability and health-related quality of life. Outcomes were collected at 45, 90 and 180 days, and 1, 2 and 3 years after the activation visit.

Results: Forty-two patients were implanted with the device and 33 (79%) were available at the 3-year appointment. Patients in this cohort presented with severe chronic low back pain (NRS = 7.0 ± 0.2) and severe disability (ODI 46.6 ± 12.0). The health-related quality of life was also severely impacted at baseline (EQ-5D 0.426 ± 0.061). Changes in pain, disability and quality of life at three-year follow-up demonstrated a statistically significant improvement between baseline and 1, 2 and 3 years. After 3 years of therapy, average NRS scores had reduced to 2.7± 0.3 and mean ODI score to 26.0 ± 3.1 while EQ-5D-5L index improved to 0.707 ± 0.036.

Conclusions: The ongoing follow-up of this post market cohort continues to demonstrate that restorative neurostimulation provides a statistically significant, clinically meaningful and durable response across pain, disability and quality-of life scores for patients suffering chronic mechanical low back pain that has been refractory to conventional management.

Trial registration: ClinicalTrials.gov Identifier: NCT01985230.

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修复性神经刺激治疗慢性机械性腰痛——英国上市后临床随访登记的三年结果

引言机械性慢性腰痛通常与腰椎最重要的稳定器腰椎多裂肌的神经肌肉控制受损有关。恢复性神经刺激是治疗这一特定亚群患者的一种方式，旨在通过双侧刺激L2内侧支来促进神经肌肉控制的恢复。迄今为止，前瞻性和随机临床试验的证据表明，疼痛、残疾和健康相关的生活质量等临床结果有了显著改善。方法本研究是一项开放性前瞻性随访研究，旨在通过恢复性神经刺激治疗伤害性慢性机械性腰痛。患者完成了疼痛、残疾和健康相关生活质量的评估。在激活访视后45、90和180天以及1、2和3年收集结果。结果42例患者植入了该装置，33例（79%）在3年的预约中可用。该队列中的患者表现为严重慢性腰痛（NRS=7.0±0.2）和严重残疾（ODI 46.6±12.0）。与健康相关的生活质量在基线时也受到严重影响（EQ-5D 0.426±0.061）。三年随访中疼痛、残疾和生活质量的变化表明，在基线和1、2和3年之间，疼痛、残疾的改善具有统计学意义。治疗3年后，平均NRS评分降至2.7±0.3，平均ODI评分降至26.0±3.1，EQ-5D-5L指数提高至0.707±0.036。结论对该上市后队列的持续随访继续表明，恢复性神经刺激在疼痛、残疾和生活质量评分方面为患有传统治疗难治的慢性机械性腰痛的患者提供了具有统计学意义、临床意义和持久的反应。试验注册ClinicalTrials.gov标识符：NCT01985230。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British Journal of Pain CLINICAL NEUROLOGY-

CiteScore

3.20

自引率

11.10%

发文量

期刊介绍： British Journal of Pain is a peer-reviewed quarterly British journal with an international multidisciplinary Editorial Board. The journal publishes original research and reviews on all major aspects of pain and pain management. Reviews reflect the body of evidence of the topic and are suitable for a multidisciplinary readership. Where empirical evidence is lacking, the reviews reflect the generally held opinions of experts in the field. The Journal has broadened its scope and has become a forum for publishing primary research together with brief reports related to pain and pain interventions. Submissions from all over the world have been published and are welcome. Official journal of the British Pain Society.