How would YOU design a clinical study to demonstrate that the ActiPatch/RecoveryRx device reduces or eliminates opioid use? Because that's what the NOPAIN Act requires.
Ilfeld's study design was good. The problem was the small sample size. If either arm had one or two heavy opioid users, that would skew the results.
It's important to note that opioid prescriptions typically instruct the patient to take the opioids only for "breakthrough pain." This study has a good design: the hypothesis was that, all else equal (including the use of tylenol and ice packs and opioids and anything else), the Arm that used the active device would take fewer opioid pills than the placebo Arm. It didn't happen. The opposite happened.
In research, all results tell the researcher something as long as the protocol wasn't compromised. What I think these results tell Ilfeld is that the sample size was too small and/or he included too many indications, some of which didn't respond as well to the ActiPatch. That, IMO, is the reason he started the SofPulse study halfway through the ActiPatch study with just three cherry-picked indications.
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