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腰椎背根神经节脉冲射频治疗腰椎神经根病的输出电流和疗效:一项前瞻性、双盲、随机先导研究。

Output Current and Efficacy of Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion in Patients With Lumbar Radiculopathy: A Prospective, Double-blind, Randomized Pilot Study.

机构信息

Department of Anesthesiology and Pain Medicine, International St. Mary's Hospital, Catholic Kwandong University School of Medicine, Incheon, Republic of Korea.

Department of Anesthesiology and Pain Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.

出版信息

Pain Physician. 2023 Nov;26(7):E797-E804.

PMID:37976483
Abstract

BACKGROUND

Lumbar radicular pain (LRP) is a common but challenging clinical symptom. Pulsed radiofrequency (PRF), a neuromodulation technique that uses short pulses of radiofrequency current, is effective in treating various pain disorders. However, few studies have been conducted on the effects of PRF and its modifying parameters.

OBJECTIVES

Our study aimed to determine the intraoperative parameters of PRF of the lumbar dorsal root ganglion (DRG) that are related to clinical effects in patients with LRP unresponsive to transforaminal epidural steroid injections (TFESI).

STUDY DESIGN

Prospective double-blind randomized controlled trial, pilot study.

SETTING

Single medical center in the Republic of Korea.

METHODS

Patients were allocated to one of 2 groups, high-voltage (60 V) or standard-voltage (45 V), according to the preset maximum voltage at which the active tip temperature does not exceed 42°C. Intraoperative parameters, such as output current, sensory threshold, and impedance, were measured. The primary outcomes were radicular pain intensity, physical functioning, global improvement and satisfaction with treatment, and adverse events. The assessments were performed up to 3 months postprocedure.

RESULTS

The patients in the standard-voltage group showed significant improvements in the Numeric Rating Scale pain score (P = 0.007) and Oswestry Disability Index (ODI) (P = 0.008) scores at 3 months post-PRF; however, no difference was observed in the high-voltage group. Among the intraoperative parameters, the output current showed a significant negative linear relationship with analgesic efficacy. The output current also showed a significant association with pain intensity (P = 0.005, R2 = 0.422) and ODI score (P = 0.004, R2 = 0.427) at 3 months postprocedure in a multiple regression analysis. The optimal cut-off value of the output current to lower pain intensity after 3 months was 163.5 mA with a sensitivity of 87.5%, specificity of 100%, and an area under the receiver operating characteristic curve value of 0.92 (95% CI. 0.76 - 1.00).

LIMITATIONS

Limitations of our study include an imbalance of baseline characteristics, small sample sizes, and short follow-up periods.

CONCLUSIONS

Lower output currents during PRF application to the lumbar DRG were associated with greater analgesic effects in patients who did not respond to therapeutic TFESI.

摘要

背景

腰椎根性疼痛(LRP)是一种常见但具有挑战性的临床症状。脉冲射频(PRF)是一种使用射频电流短脉冲的神经调节技术,对治疗各种疼痛疾病有效。然而,关于 PRF 及其调节参数的影响的研究较少。

目的

我们的研究旨在确定与接受经椎间孔硬膜外类固醇注射(TFESI)治疗后无反应的 LRP 患者的临床效果相关的腰椎背根神经节(DRG)PRF 的术中参数。

研究设计

前瞻性双盲随机对照试验,初步研究。

设置

韩国的一家医疗中心。

方法

根据预设的最大电压,将患者分配到高电压(60 V)或标准电压(45 V)组,在此最大电压下,活动尖端温度不超过 42°C。测量术中参数,如输出电流、感觉阈值和阻抗。主要结果是根性疼痛强度、身体功能、整体改善和对治疗的满意度以及不良事件。评估在术后 3 个月内进行。

结果

标准电压组患者在 PRF 后 3 个月时 Numeric Rating Scale 疼痛评分(P = 0.007)和 Oswestry 残疾指数(ODI)评分(P = 0.008)显著改善;然而,高电压组没有差异。在术中参数中,输出电流与镇痛效果呈显著负线性关系。在多元回归分析中,输出电流与术后 3 个月时的疼痛强度(P = 0.005,R2 = 0.422)和 ODI 评分(P = 0.004,R2 = 0.427)也有显著关联。术后 3 个月时降低疼痛强度的输出电流最佳截断值为 163.5 mA,灵敏度为 87.5%,特异性为 100%,受试者工作特征曲线下面积值为 0.92(95%CI. 0.76 - 1.00)。

局限性

我们研究的局限性包括基线特征不平衡、样本量小和随访时间短。

结论

在对腰椎 DRG 进行 PRF 应用时,较低的输出电流与接受治疗性 TFESI 治疗后无反应的患者的更大镇痛效果相关。

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