Ilfeld Brian M, Finneran John J, Said Engy T, Ball Scott T, Wallace Anne M, Broderick Ryan C, Sandler Bryan J, Doucet Jay J, Hu Sandy R, Cha Brannon J, Murthy Adhithi Narayana, Abdullah Baharin
Department of Anesthesiology, University California San Diego, La Jolla, California, USA.
The Outcomes Research Consortium, University of Texas, Houston, Houston, Texas.
Pain Pract. 2025 Feb;25(2):e70007. doi: 10.1111/papr.70007.
Nonthermal, pulsed shortwave (radiofrequency) therapy (PSWT) is a nonpharmacologic, noninvasive modality that limited evidence suggests provides analgesia. Its potential favorable risk-benefit ratio stems from its lack of side effects and significant medical risks, applicability to any anatomic location, long treatment duration, and ease of application by simply affixing it with tape. Even with a relatively small treatment effect, PSWT might contribute to a multimodal analgesic regimen, similar to acetaminophen. However, widespread clinical use is hindered by a lack of systematic evidence. The current randomized, controlled pilot study was undertaken to determine the feasibility and optimize the protocol for a subsequent definitive investigation and estimate the treatment effect of PSWT on postoperative pain and opioid consumption.
Within the recovery room following primary knee and hip arthroplasty, cholecystectomy, hernia repair, and non-mastectomy breast surgery, we applied 1-3 PSWT devices (Model 088, BioElectronics Corporation, Frederick, Maryland) over the surgical bandages. Participants were randomized to 28 days of either active or sham treatment in a double-masked fashion. The outcomes of primary interest were the cumulative opioid consumption and the mean of the "average" and "worst" daily pain measured with the Numeric Rating Scale over the first 7 postoperative days.
During the first 7 postoperative days, oxycodone consumption in participants given active treatment (n = 55) was a mean (SD) of 21 mg (24) versus 17 mg (26) in patients given sham (n = 57): difference 4 (95% CI, -5 to 13), p = 0.376. During this same period, the "average" daily pain intensity in patients given active treatment was 2.4 (1.6) versus 2.6 (1.7) in sham: difference -0.2 (95% CI -0.8 to 0.5), p = 0.597. Concurrently, the worst/maximum pain for the active group was 4.6 (2.0) versus 4.7 (2.1) in sham: difference -0.1 (95% CI -0.8 to 0.7), p = 0.888. No device-related systemic side effects or serious adverse events were identified.
Pulsed shortwave (radiofrequency) therapy did not reduce pain scores and opioid requirements to a statistically significant or clinically relevant degree during the initial postoperative week in this pilot study. These results must be replicated with a subsequent study before being considered definitive. Data from this preliminary study may be used to help plan future trials.
非热脉冲短波（射频）疗法（PSWT）是一种非药物、非侵入性的治疗方式，现有有限证据表明其具有镇痛作用。其潜在的良好风险效益比源于其无副作用和重大医疗风险、适用于任何解剖部位、治疗时间长以及通过简单粘贴胶带即可轻松应用。即使治疗效果相对较小，PSWT也可能有助于多模式镇痛方案，类似于对乙酰氨基酚。然而，缺乏系统证据阻碍了其广泛的临床应用。当前的随机对照试验研究旨在确定可行性并优化后续确定性研究的方案，同时评估PSWT对术后疼痛和阿片类药物消耗的治疗效果。
在初次膝关节和髋关节置换术、胆囊切除术、疝气修补术以及非乳房切除术的乳房手术后的恢复室中，我们在手术绷带上应用1 - 3个PSWT设备（型号088，BioElectronics Corporation，弗雷德里克，马里兰州）。参与者以双盲方式随机分为接受28天的主动治疗或假治疗组。主要关注的结果是术后前7天累积阿片类药物消耗量以及用数字评分量表测量的“平均”和“最严重”每日疼痛的平均值。
在术后的前7天，接受主动治疗的参与者（n = 55）的羟考酮消耗量平均（标准差）为21毫克（24），而接受假治疗的患者（n = 57）为17毫克（26）：差异为4（95%置信区间，-5至13），p = 0.376。在同一时期，接受主动治疗的患者的“平均”每日疼痛强度为2.4（1.6），而假治疗组为2.6（1.7）：差异为-0.2（95%置信区间-0.8至0.5），p = 0.597。同时，主动治疗组的最严重/最大疼痛为4.6（2.0），而假治疗组为4.7（2.1）：差异为-0.1（95%置信区间-0.8至0.7），p = 0.888。未发现与设备相关的全身性副作用或严重不良事件。
在这项试验研究中，脉冲短波（射频）疗法在术后第一周内并未将疼痛评分和阿片类药物需求量降低到具有统计学意义或临床相关性的程度。在被视为确定性结论之前，这些结果必须在后续研究中得到重复验证。这项初步研究的数据可用于帮助规划未来的试验。
