Wearable, noninvasive, pulsed shortwave (radiofrequency) therapy for postoperative analgesia: A randomized, double‐masked, sham‐controlled pilot study

• DOI: 10.1111/papr.70007
• Publication Date: 2025-01-20T09:56:45Z
• Authors: Brian M. Ilfeld; John J. Finneran; Engy T. Said; Scott T. Ball; Anne M. Wallace; Ryan C. Broderick; Bryan J. Sandler; Jay J. Doucet; Sandy R. Hu; Brannon J. Cha; Adhithi Narayana ...; Baharin Abdullah
• Keywords: Male; Adult; Analgesics; 610; Pain; analgesia; Pilot Projects; Opioid; surgical analgesia; Middle Aged; Pulsed Radiofrequency Treatment; Wearable Electronic Devices; Double-Blind Method; 617; Humans; Pain Management; Female; pulsed electromagnetic fields; Postoperative; postoperative pain; post‐surgical pain; Aged; Pain Measurement; Research Article

Abstract Background 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, ease application by simply affixing it with tape. Even relatively small effect, PSWT might contribute multimodal analgesic regimen, similar acetaminophen. However, widespread clinical use hindered systematic evidence. The current randomized, controlled pilot study was undertaken determine the feasibility optimize protocol for subsequent definitive investigation estimate effect on postoperative pain opioid consumption. Methods Within recovery room following primary knee hip arthroplasty, cholecystectomy, hernia repair, non‐mastectomy breast surgery, we applied 1–3 devices (Model 088, BioElectronics Corporation, Frederick, Maryland) over surgical bandages. Participants were randomized 28 days either active or sham in double‐masked fashion. outcomes interest cumulative consumption mean “average” “worst” daily measured Numeric Rating Scale first 7 days. Results During days, oxycodone participants given ( n = 55) (SD) 21 mg (24) versus 17 (26) patients 57): difference 4 (95% CI, −5 13), p 0.376. this same period, intensity 2.4 (1.6) 2.6 (1.7) sham: −0.2 CI −0.8 0.5), 0.597. Concurrently, worst/maximum group 4.6 (2.0) 4.7 (2.1) −0.1 0.7), 0.888. No device‐related systemic serious adverse events identified. Conclusions Pulsed did not reduce scores requirements statistically clinically relevant degree during initial week study. These results must be replicated before being considered definitive. Data preliminary may used help plan future trials.