Pulsed Shortwave (Radiofrequency) Therapy With a Noninvasive, Wearable, Disposable Device: A Randomized, Participant- and Assessor-Masked, Sham-Controlled Pilot Study.

OBJECTIVES

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.

MATERIALS AND METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION

The Clinicaltrials.gov registration number for the study is NCT05796583.