Kim Chan-Sik, Kim Yujin, Kim Doo-Hwan, Kwon Hyun-Jung, Shin Jin-Woo, Choi Seong-Soo
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Neuromodulation. 2025 Feb;28(2):256-262. doi: 10.1016/j.neurom.2024.03.006. Epub 2024 May 16.
We hypothesized that the duration of pulsed radiofrequency (PRF) application may affect the effectiveness of PRF in patients with chronic lumbosacral radicular pain (LRP).
In this prospective, double-blind, randomized study, 68 patients were randomly allocated to two groups: a 6-minute group, in which PRF was applied at 42 °C for 2 minutes followed by a 2-minute pause, repeated three times; and a 12-minute group, with a continuous application at 42 °C for 12 minutes. The total application time in each group was equal. After PRF, 2 to 3 mL of 1% lidocaine with 5 mg of dexamethasone was injected. The primary outcome was the intensity of leg pain measured using a numerical rating scale (NRS) three months after the procedure. The secondary outcomes were intensities of leg and back pain, the Oswestry Disability Index (ODI), the Medication Quantification Scale III (MQS), the Global Perceived Effect of Satisfaction (GPES), and the incidence of adverse events during follow-up. Primary and secondary outcomes were analyzed using a linear mixed-effect model in the modified intention-to-treat population.
Each group comprised 34 patients. Three patients in each group did not receive the allocated intervention owing to alleviation of pain. The estimated NRS mean of leg pain at three months was 4.0 (95% CI, 3.2-4.9) and 4.5 (95% CI, 3.6-5.4) in the 6- and 12-minute groups, respectively, with no significant difference between groups (estimated mean difference, -0.5; 95% CI, -1.8 to 0.8; p = 0.436). Regarding the intensities of leg and back pain, ODI, MQS, and GPES, there was no significant difference between the two groups except for GPES at six months. No adverse events were observed in the groups.
Among patients with chronic LRP, a prolonged PRF application of 12 minutes, compared with 6 minutes, caused no significant difference in leg pain intensity.
The Clinicaltrials.gov registration number under the Clinical Trial Registry of Korea for the study is KCT0003850; https://cris.nih.go.kr.
我们假设脉冲射频（PRF）应用的持续时间可能会影响其对慢性腰骶神经根性疼痛（LRP）患者的疗效。
在这项前瞻性、双盲、随机研究中，68例患者被随机分为两组：6分钟组，PRF在42℃下应用2分钟，随后暂停2分钟，重复三次；12分钟组，在42℃下持续应用12分钟。每组的总应用时间相等。PRF后，注射2至3 mL含5 mg地塞米松的1%利多卡因。主要结局是术后三个月使用数字评分量表（NRS）测量的腿痛强度。次要结局包括腿痛和背痛强度、Oswestry功能障碍指数（ODI）、药物量化量表III（MQS）、总体满意度（GPES）以及随访期间不良事件的发生率。在改良意向性治疗人群中使用线性混合效应模型分析主要和次要结局。
每组包括34例患者。每组有3例患者因疼痛缓解未接受分配的干预。6分钟组和12分钟组术后三个月估计的腿痛NRS均值分别为4.0（95%CI，3.2 - 4.9）和4.5（95%CI，3.6 - 5.4），两组间无显著差异（估计均值差异为 - 0.5；95%CI， - 1.8至0.8；p = 0.436）。关于腿痛和背痛强度、ODI、MQS和GPES，除六个月时的GPES外，两组间无显著差异。两组均未观察到不良事件。
在慢性LRP患者中，与6分钟的PRF应用相比，延长至12分钟的PRF应用在腿痛强度方面无显著差异。
该研究在韩国临床试验注册中心的Clinicaltrials.gov注册号为KCT0003850；https://cris.nih.go.kr。
