Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju City, Republic of Korea.
Clinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju City, Republic of Korea.
PLoS One. 2022 May 31;17(5):e0269282. doi: 10.1371/journal.pone.0269282. eCollection 2022.
This study aimed to provide preliminary evidence for the efficacy of invasive laser acupuncture (ILA) for chronic non-specific low back pain (CNLBP). This was a single-center, randomized, patient and assessor-blinded, placebo-controlled, parallel-arm, clinical trial with a 1:1:1 allocation ratio that included a full analysis set. Forty-five participants with CNLBP were randomly assigned to the control group (sham laser), 650 group (650 nm-wavelength ILA), or 830 group (830 nm-wavelength ILA) (n = 15/group). All participants received ILA for 10 min, followed by electroacupuncture for 10 min on the same day. The treatment was performed once per day, twice per week for 4 weeks at bilateral BL23, BL24, BL25, and GB30. The primary outcome was the among-group difference of changes in the visual analog scale (VAS) scores at intervention endpoint (week 4). The secondary outcomes were the among-group difference of changes in VAS at 4 weeks after intervention completion (week 8), those in the Korean version of the Oswestry Disability Index (ODI) and the European Quality of Life Five-Dimension- Five-Level (EQ-5D-5L) at intervention endpoint (week 4) and 4 weeks after intervention completion (week 8). The VAS scores of the 650 group decreased significantly compared with those of the control group (p = 0.047; week 4 vs. week 0). The ODI scores of the 650 group (p = 0.018, week 4 vs. week 0; p = 0.006, week 8 vs. week 0) and 830 group (p = 0.014, week 4 vs. week 0) decreased significantly compared with those of the control group. There was no adverse event related to ILA and no significant difference in changes in vital signs among the three groups. The 650 group showed significant improvements in pain intensity and functional disability. The 830 group showed significant improvements in functional disability. Therefore, ILA therapy at 650 nm and 830 nm wavelengths can be used to treat CNLBP.
本研究旨在为慢性非特异性下腰痛(CNLBP)的侵入性激光针灸(ILA)疗效提供初步证据。这是一项单中心、随机、患者和评估者双盲、安慰剂对照、平行臂、临床试验,分配比例为 1:1:1,包括全分析集。45 名 CNLBP 患者被随机分配至对照组(假激光)、650 组(650nm 波长 ILA)或 830 组(830nm 波长 ILA)(n=15/组)。所有患者均接受 ILA 治疗 10 分钟,同日再接受电针治疗 10 分钟。治疗方法为每天一次,每周两次,共 4 周,双侧 BL23、BL24、BL25 和 GB30 各治疗一次。主要结局为干预终点(第 4 周)时各组间 VAS 评分变化的组间差异。次要结局为干预完成后 4 周(第 8 周)时 VAS 评分的组间差异、韩国版 Oswestry 残疾指数(ODI)和欧洲生活质量五维-五水平(EQ-5D-5L)评分的组间差异(干预终点,第 4 周;干预完成后 4 周,第 8 周)。与对照组相比,650 组的 VAS 评分显著降低(p=0.047;第 4 周 vs. 第 0 周)。与对照组相比,650 组(p=0.018,第 4 周 vs. 第 0 周;p=0.006,第 8 周 vs. 第 0 周)和 830 组(p=0.014,第 4 周 vs. 第 0 周)的 ODI 评分显著降低。三组间均未发生与 ILA 相关的不良事件,生命体征变化无显著差异。650 组疼痛强度和功能障碍均显著改善,830 组功能障碍显著改善。因此,650nm 和 830nm 波长的 ILA 治疗可用于治疗 CNLBP。