Ku Boncho, Jun Minho, Lee Jun-Hwan, Jeon Young-Ju, Kim Young-Min, Kang Jaehui, Lee Yu-Jung, Kim Kahye, Heo Hyun, Kim Jaeuk U
Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Evid Based Complement Alternat Med. 2018 Aug 12;2018:4510909. doi: 10.1155/2018/4510909. eCollection 2018.
The objective of this study was to evaluate the pain-relief efficacy of thermal stimulation induced by a pulsed radiofrequency (PRF) thermal stimulation applied to acupoints (APs) in patients with low back pain (LBP). The study was designed as a randomized, single-blinded, placebo-controlled trial Fifty-six LBP patients whose minimum pain intensity score on a visual analogue scale (VAS, 0-100 mm) was more than 30 mm were randomly allocated to either the placebo-controlled or the treatment group at a 1:1 ratio. The treatment and placebo-controlled groups received PRF thermal stimulation plus cupping therapy and cupping therapy only, respectively. Each patient was scheduled to receive a total of three treatment sessions over one week with allowing a window up to 4 days. Six of the 13 predefined APs were selected differently for each session depending on the change in patient's symptoms and intensity of pain. The primary outcome was the mean difference between the placebo-controlled and treatment group of VAS changes from the baseline to the end of the follow-up period.
The patients' reported VAS scores from baseline to the end of follow-up (average: 9.8 days) were significantly decreased by 8.036 points (two-sided 95% CI, -11.841 to -4.231) and 13.393 points (two-sided 95% CI: 17.198 to -9.588) in the treatment and the placebo-controlled groups, respectively. However, the change in VAS scores between the treatment group and the placebo-controlled group was not significantly different (2.015 mm, two-sided 95% CI: -5.288 to 9.317).
The trial results indicated that treatment with either PRF thermal stimulation with cupping therapy or cupping therapy alone effectively relieved LBP. The efficacy of PRF thermal stimulation combined with cupping therapy was not superior to that of cupping therapy alone. Clinical Research Information Service (KCT0002137). The trial was registered retrospectively on 10 November, 2016.
本研究的目的是评估脉冲射频（PRF）热刺激应用于腰痛（LBP）患者穴位（AP）所产生的止痛效果。本研究设计为随机、单盲、安慰剂对照试验。56例视觉模拟量表（VAS，0 - 100mm）上最小疼痛强度评分超过30mm的LBP患者按1:1比例随机分配至安慰剂对照组或治疗组。治疗组和安慰剂对照组分别接受PRF热刺激加拔罐疗法和仅拔罐疗法。每位患者计划在一周内共接受三次治疗，允许有长达4天的时间窗口。根据患者症状变化和疼痛强度，每次治疗从13个预先定义的穴位中选择6个不同的穴位。主要结局是安慰剂对照组和治疗组从基线到随访期末VAS变化的平均差异。
治疗组和安慰剂对照组患者从基线到随访期末（平均：9.8天）报告的VAS评分分别显著降低了8.036分（双侧95%CI，-11.841至-4.231）和13.393分（双侧95%CI：-17.198至-9.588）。然而，治疗组和安慰剂对照组之间VAS评分的变化无显著差异（2.015mm，双侧95%CI：-5.288至9.317）。
试验结果表明，PRF热刺激加拔罐疗法或单独拔罐疗法均能有效缓解LBP。PRF热刺激联合拔罐疗法的疗效并不优于单独拔罐疗法。临床研究信息服务（KCT0002137）。该试验于2016年11月10日进行回顾性注册。
