Ilfeld Brian M, Finneran John J, Said Engy T, Ball Scott T, Sandler Bryan J, Broderick Ryan C, Gonzales Francis B, Lau Nathan J, Schaar Adam, Abdullah Baharin
Department of Anesthesiology, University of California San Diego, San Diego, CA, USA; Outcomes Research Consortium, University of Texas, Houston, TX, USA.
Department of Anesthesiology, University of California San Diego, San Diego, CA, USA; Outcomes Research Consortium, University of Texas, Houston, TX, USA.
Neuromodulation. 2025 Jun;28(4):682-689. doi: 10.1016/j.neurom.2025.01.008. Epub 2025 Feb 20.
Pulsed shortwave therapy (PSWT) is a nonpharmacologic/noninvasive modality that may offer analgesic benefits without notable side effects or complications. This pilot study aimed to assess the feasibility of a PSWT protocol and provide an estimate of its treatment effects.
The study included adults who underwent cholecystectomy or unilateral total hip or knee arthroplasty. Participants were randomized to eight days of either PSWT with a single functioning device (SofPulse, Endonovo Therapeutics, Woodland Hills, CA) or a sham device placed over the surgical bandages in a participant- and assessor-masked fashion. The primary end point was the sum of the average and worst (maximum) daily pain intensity as measured with the numeric rating scale collected over the first seven postoperative days.
No systemic side effects or significant complications occurred. During the first seven postoperative days, the sum of the daily pain intensity scores in the active group was a mean (SD) of 28 (11) vs 34 (14) in sham: difference -6.5 (95% CI, -12.4 to -0.6), p = 0.032. During the same period, cumulative oxycodone consumption in the active group was a mean (SD) of 4.6 (4.9) mg vs 5.1 (7.3) mg in sham: difference -0.5 (95% CI, -3.4 to 2.5), p = 0.761. Subgroup analysis suggested that the analgesic effect for knee arthroplasty was greater than for the other surgical procedures.
PSWT is feasible for inpatients and outpatients, and reduced pain over the first postoperative week. These results are preliminary and should be replicated with a subsequent study before being considered definitive. Although this pilot study was inadequately powered to conclusively identify statistically significant differences between treatments for the secondary end points, if the analgesic improvements are successfully replicated in a definitive trial, they would meet or exceed the benefits identified for oral acetaminophen. Data from this pilot study may be used to help plan future trials.
The Clinicaltrials.gov registration number for the study is NCT05796583.
脉冲短波疗法（PSWT）是一种非药物/非侵入性治疗方式，可能具有镇痛效果且无明显副作用或并发症。本初步研究旨在评估PSWT方案的可行性，并对其治疗效果进行估计。
该研究纳入了接受胆囊切除术或单侧全髋关节或膝关节置换术的成年人。参与者被随机分为两组，一组使用单个功能设备（SofPulse，Endonovo Therapeutics，加利福尼亚州伍德兰希尔斯）进行为期八天的PSWT治疗，另一组使用假设备以参与者和评估者双盲的方式置于手术绷带上。主要终点是术后头七天使用数字评分量表测量的平均每日疼痛强度与最差（最大）每日疼痛强度之和。
未出现全身性副作用或重大并发症。术后头七天，治疗组每日疼痛强度评分总和的均值（标准差）为28（11），而假治疗组为34（14）：差值为-6.5（95%置信区间，-12.4至-0.6），p = 0.032。同一时期，治疗组羟考酮的累积消耗量均值（标准差）为4.6（4.9）mg，假治疗组为5.1（7.3）mg：差值为-0.5（95%置信区间，-3.4至2.5），p = 0.761。亚组分析表明，膝关节置换术的镇痛效果大于其他手术。
PSWT对住院患者和门诊患者均可行，且能在术后第一周减轻疼痛。这些结果是初步的，在被视为确定性结果之前应在后续研究中进行重复验证。尽管本初步研究的样本量不足以确凿地确定次要终点治疗之间的统计学显著差异，但如果在确定性试验中成功重复镇痛改善效果，这些效果将达到或超过口服对乙酰氨基酚的益处。本初步研究的数据可用于帮助规划未来试验。
该研究在Clinicaltrials.gov上的注册号为NCT05796583。
