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Re: The_Pro post# 327962

Wednesday, 03/27/2024 9:38:16 PM

Wednesday, March 27, 2024 9:38:16 PM

Post# of 330338
Scroll down to the second “study”…do you mean this Dr. Adam Lowenstein?
https://www.bielcorp.com/clinical-evidence/postoperative-pain-edema/

Control of Postoperative Pain with a Wearable Continuously Operating Pulsed Radiofrequency Energy Device: A Preliminary Study

Ian M. Rawe, Adam Lowenstein, C. Raul Barcelo & David G. Genecov

BioElectronics RecoveryRx® was investigated in a double blind, randomized and placebo controlled study for postoperative pain and narcotic pain medication use following breast augmentation surgery. Data, VAS pain scores (0-10) and medication was collected for seven days post-surgery. The group using RecoveryRx® experienced 50% less pain and consumed significantly less narcotic pain medications. The study is published in the Aesthetics of Plastic Surgery.

Oh, for those that get stuck on “study” vs clinical trial…
It’s been noted by some that because “Study” terminology is used, it is therefore not a clinical trial.

terminology…
What are the types of clinical research?
There are 2 main types of clinical research:
* Clinical trials, also called interventional studies
* Observational studies
Both may try to learn more about an intervention, which may be a drug, behavior, or medical device. The main difference is clinical trial participants are assigned to get an intervention, but observational study participants are not assigned to get an intervention. - bold emphasis mine
https://clinicaltrials.gov/study-basics/learn-about-studies

For the forum…
Question of the day, or maybe everyday from now until start of the NOPAIN Act and CMS insurance reimbursement 1/2025…

Was this “study” surgery-related, and an intervention used, and if so, is it BIEL’s product, and lastly, does this preliminary “study” qualify as a bona fide clinical trial or will someone have a beef with “preliminary” too?