Amirdelfan Kasra, Hong Mindy, Tay Bobby, Reddy Surekha, Reddy Vinay, Yang Michael, Khanna Krishn, Shirvalkar Prasad, Abrecht Christopher, Gulati Amitabh
IPM Medical Group, Walnut Creek, CA, USA.
Hinge Health, San Francisco, CA, USA.
J Pain Res. 2021 Sep 22;14:2991-2999. doi: 10.2147/JPR.S325230. eCollection 2021.
This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).
A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann-Whitney -test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.
The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen's (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).
A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.
本研究旨在探讨高频脉冲疗法（HFIT）对慢性下腰痛（CLBP）患者疼痛和功能的影响。
在美国加利福尼亚州的5个骨科和疼痛中心进行了一项关于HFIT系统与假治疗对照的试点随机对照试验。36名寻求CLBP临床治疗的患者被随机分组。主要结局指标是通过六分钟步行试验（6MWT）测量的功能。次要结局指标包括功能（计时起立行走试验 [TUG] 和Oswestry功能障碍指数 [ODI]）、疼痛（数字评定量表 [NRS]）、生活质量（患者总体改善印象 [PGIC]）以及设备使用情况。在基线时以及随访的4周内每周对患者进行评估。采用曼 - 惠特尼检验分析各结局指标的变化。使用重复测量方差分析评估治疗随时间的效果。
受试者的平均年龄为53.9 ± 15.7（均值 ± 标准差）岁，慢性下腰痛病史为12.1 ± 8.8年。与基线评分相比，接受HFIT设备治疗的患者在第2周 [科恩效应量（95%置信区间）：0.33（0.02，0.61）]、第3周 [0.32（0.01，0.59）] 和第4周 [0.31（0.01，0.60）] 的6MWT评分显著更高（p < 0.05）。治疗组患者在第3周的TUG评分显著更低 [0.30（0.04，0.57）]，在第2周 [0.34（0.02，0.58）] 和第4周 [0.41（0.10，0.67）] 的NRS评分显著更低（p < 0.05）。
一项更大规模的随机对照试验可以基于本研究的结果来检验HFIT是否能有效减轻CLBP患者的疼痛并改善其功能。本研究显示了使用HFIT的受试者在功能改善和疼痛减轻方面令人鼓舞的证据。HFIT的有效性和微创性质有望显著改善CLBP患者的治疗管理。
