Bioelectronics Corp (BIEL)

[srinsocal]

From the UCSD statements on the Postoperative Analgesia Study

"Study intervention. The pulsed shortwave device (2 devices, if there are multiple incisions or the incision is larger than the device diameter; 3 devices for total knee and hip arthroplasty or spinal surgery) will be affixed over the primary wound area(s) using tape and activated prior to recovery room discharge (Experimental). The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this pilot study, and patients will be encouraged to move the devices to a new anatomic location until relief is optimized."

"Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures."

"Hypothesis 2: Nonthermal, pulsed shortwave therapy decreases opioid use in the 7 days following moderate-to-severely painful surgical procedures."

"The two outcomes of primary interest will be (1) the "average" and "worst" pain measured with the Numeric Rating Scale (included in the Brief Pain Inventory pain domain), and (2) opioid consumption within the first 7 postoperative days."

"Treatment with BioElectronics Model 088"

"Status - in progress, not accepting new patients
Start Date - July 2022
Completion Date - April 3, 2024 (estimated)
Sponsor - University of California, San Diego
ID - NCT05399355
Study Type - Interventional
Participants - About 120 people participating
Last Updated - February 8, 2024"

https://clinicaltrials.ucbraid.org/trial/NCT05399355