Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin University, 185 Gunjae-ro, Naju City, 58245, Republic of Korea.
Clinical Research Center, DongShin University Gwangju Korean Medicine Hospital, 141 Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
Trials. 2021 Feb 5;22(1):118. doi: 10.1186/s13063-021-05038-6.
Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) involves the simultaneous application of invasive acupuncture treatment at acupoints and focused laser irradiation. The efficacy of ILA for CLBP remains controversial owing to the insufficient clinical trial data. We intend to obtain basic data regarding the efficacy and safety of ILA for CLBP by comparing the effects of different wavelengths of ILA on CLBP.
This will be a prospective, patient-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial. Forty-five participants with CLBP will be randomized in equal numbers into the control, 650-nm ILA (650 ILA), or 830-nm ILA (830 ILA) group. The control group will receive sham ILA for 10 min and real electroacupuncture (EA) for 10 min. The 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min once/day, twice a week for 4 weeks, at bilateral Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), and Huantiao (GB30). The primary outcome will be an improvement in pain intensity assessed using the visual analog scale. Scores in the Korean version of the Oswestry Disability Index and the European Quality of Life Five Dimension Five Level scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 4 weeks after the first intervention (at the end of the intervention), and 4 weeks after completion of the intervention.
The study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of ILA for the treatment of CLBP.
This trial was registered with the Clinical Research Information Service (registration No. KCT0004610 ; http://cris.nih.go.kr ). Registered on 7 January 2020.
慢性非特异性下腰痛（CLBP）是一种常见的肌肉骨骼疾病，患者寻求补充和替代医学治疗，包括激光针灸（LA）。侵入性 LA（ILA）包括同时在穴位进行侵入性针灸治疗和聚焦激光辐射。由于临床研究数据不足，ILA 治疗 CLBP 的疗效仍存在争议。我们旨在通过比较不同波长 ILA 对 CLBP 的影响，获得关于 ILA 治疗 CLBP 的疗效和安全性的基本数据。
这将是一项前瞻性、患者盲法、平行臂、单中心（韩国光州东信大学韩国医学医院）、先导随机对照临床试验。将 45 名 CLBP 患者随机等分为对照组、650nm ILA（650ILA）组或 830nm ILA（830ILA）组。对照组将接受假 ILA 治疗 10 分钟和真电针（EA）治疗 10 分钟。650 和 830ILA 组将接受真 ILA（即 650ILA 组，650nm 波长；830ILA 组，830nm 波长）治疗 10 分钟和真 EA 治疗 10 分钟，每周两次，共 4 周，双侧肾俞（BL23）、气海穴（BL24）、大肠俞（BL25）和环跳穴（GB30）。主要结局指标是使用视觉模拟评分法评估疼痛强度的改善。记录韩国版 Oswestry 残疾指数和欧洲生活质量五维五水平量表的分数作为次要结局指标。所有评分均在基线（干预前）、第一次干预后 4 周（干预结束时）和干预完成后 4 周记录。
该研究有望提供关于 ILA 治疗 CLBP 的疗效、安全性和实用性的初步证据。
该试验已在临床研究信息服务处（注册号 KCT0004610；http://cris.nih.go.kr）注册。于 2020 年 1 月 7 日注册。
