Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids

Abstract

Introduction: Despite their poor tolerance, especially in the elderly, weak opioids (WO) remain commonly prescribed for patients with knee osteoarthritis (KOA). We compared the efficacy and safety of a new wearable transcutaneous electrical nerve stimulation (W-TENS) device with WO for the treatment of moderate-to-severe, nociceptive KOA chronic pain. Methods: The study was a non-inferiority, multicentric, prospective, randomized, single-blind, controlled, 2-parallel groups Trial. A total of 110 patients with KOA were included (Kellgren-Lawrence radiographic grade ⩾2; American College of Rheumatology criteria), with chronic moderate-to-severe nociceptive pain (mean 8-day pain intensity (PI) ⩾ 4 on an 11-point numerical rating scale), in failure to non-opioid analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs). Patients with neuropathic pain were excluded. The co-primary endpoints were mean PI at 3 months (M3) and number of potentially treatment-related adverse events (TRAEs). Secondary outcomes included Western Ontario MAC Master University function subscale (range, 0–68), additional pain and quality of life measures, and responder rates. Results: The non-inferiority of W-TENS was demonstrated in both the per protocol (PP) and intent-to-treat (ITT) populations. At M3, PI in PP population was 3.87 (2.12) compared with 4.66 (2.37) [delta: −0.79 (0.44); 95% CI (−1.65, 0.08)] in W-TENS and WO groups, respectively. A planned superiority analysis showed a significant superiority of W-TENS over WO on PI at M3 ( p = 0.0124). The number of TRAEs was significantly lower in the W-TENS group ( n = 7) than in the WO group ( n = 36) ( p < 0.001). Other secondary outcomes also favored W-TENS. Conclusion: W-TENS was more effective and better tolerated than WO in the treatment of chronic nociceptive KOA pain and offers an interesting non-pharmacological analgesic alternative in the management of KOA. Trial Registration: ClinicalTrials.gov: NCT03902340

Treatment of Knee Osteoarthritis with Transcutaneous Electrical Nerve Stimulation

“…In the average eight-day pain intensity index, The W-TENS and WO(weak opioids) groups were 3.87 (2.12) and 4.66 (2.37), respectively. Among the treatment-related adverse events, seven patients were reported in the W-TENS group versus 36 patients in the WO group, this shows that W-TENS is obviously better than WO in treating KOA pain [22].…”

Current Non-surgical Management of Knee Osteoarthritis

“…Quadriceps strengthening exercises using the quadriceps bench will increase the number of sarcomeres and muscle fibers (actin and myosin filaments needed in muscle contraction), causing an increase in muscle strength. If the exercise is performed repeatedly, it will increase stability and reduce subchondral inflammation in the capsule, thereby reducing pain [ 9 , 10 ].…”

Neuromodulation of the peripheral nervous system: Bioelectronic technology and prospective developments

“…Reproduced with permission. [76] Copyright 2022, the authors. (h) Improvement in OAB symptom scores of placebo and TENS groups.…”

“…Maheu et al conducted a randomized controlled trial on patients with knee osteoarthritis and found that a wearable TENS device, shown in Figure 2g, was effective in reducing chronic pain. [76] Moreover, the authors demonstrated that the non-pharmacological TENS method was more effective and safer than the weak opioids commonly used as pain relievers, an important finding as safety is of significant concern when treating chronic pain. Numerous other studies have investigated the use of TENS for managing neuropathic pain, including in conditions such as diabetic peripheral neuropathic pain and postherpetic neuralgia.…”

“…(g) Photograph of a wearable TENS device attached to standardized positions. Reproduced with permission [76] . Copyright 2022, the authors.…”