In a randomized controlled prospective study, a novel wearable transcutaneous electrical nerve stimulation (W-TENS) device showed superior efficacy and improved tolerability in comparison with weak opioids to treat knee osteoarthritis pain.

Researchers assessed the effectiveness and safety of W-TENS device with weak opioids in 110 knee osteoarthritis people (age> 55 years) with chronic nociceptive pain and who showed unsatisfactory response to non-opioid analgesic agents, including nonsteroidal anti-inflammatory drugs. People having neuropathic pain were eliminated from the trial.

In this non-inferiority, multicentric, single-blind trial, the mean pain intensity at three months and the number of potentially treatment-related adverse events (TRAEs) were the co-primary endpoints ascertained while the secondary endpoints included responder rates, Western Ontario MAC Master University function subscale, and additional quality of life and pain measures.

In both per-protocol and intent-to-treat populations, W-TENS was non-inferior to weak opioids. At month 3, pain intensity in the per-protocol population in W-TENS and weak opioids groups is shown in Table 1. The number of TRAEs was markedly reduced in the W-TENS group when compared to the weak opioids group (Table 1):

A planned superiority assessment illustrated remarkable superiority of W-TENS over weak opioids on pain intensity at month 3. The other secondary endpoints also favored W-TENS. Thus, the innovative W-TENS device is effective and safe to treat knee osteoarthritis pain and provides a promising non-pharmacological analgesic substitute to manage osteoarthritis of the knee.