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

Emmanuel Maheu, Sandrine Soriot-Thomas, Eric Noel, Hervé Ganry, Eric Lespessailles, Bernard Cortet, Emmanuel Maheu, Sandrine Soriot-Thomas, Eric Noel, Hervé Ganry, Eric Lespessailles, Bernard Cortet

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.

Keywords: TENS; clinical trial; knee osteoarthritis; opioids; pain management.

Conflict of interest statement

Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.M.: punctual interventions, Board member, expertise, speaker at congress for Amgen, Expanscience, Fidia, Mylan, Pierre Fabre, Sublimed, TRB Chemedica; S.S.-T.: Board member, expertise, trainer and speaker at congress for Grünenthal, Sublimed, Kiowa-Kirin Sanofi, Expansciences, Teva, Mylan, Therabel; E.N.: Occasional expertise for Sublimed. H.G.: Expertise for Sublimed, Ludocare, UCB; E.L.: Occasional interventions as an expert or speaker for Amgen, Expanscience, Lilly, MSD, Novartis, Sublimed, Theramex, UCB; B.C.: Occasional interventions as an expert or speaker for Alexion, Amgen, Expanscience, Ferring, Kyowa-Kirin, Lilly, Mylan, MSD, Novartis, Sublimed, Theramex, and UCB.

© The Author(s), 2022.

Figures

Figure 1.
Figure 1.
Standardized positioning of W-TENS electrodes. W-TENS is an advanced, mobile app-enabled, wearable TENS delivering electrical stimulation through adhesive electrodes applied to the skin and connected to the box. 50 mm × 50 mm square electrodes are positioned on the path of the infrapatellar nerve, branch of the saphenous nerve and innervating the joint. 50 mm × 90 mm rectangular electrodes are positioned on the quadriceps.
Figure 2.
Figure 2.
Consolidated standards of reporting trials (CONSORT) flow diagram showing the patients’ course during the study. D0, Inclusion day; DN4, Neuropathic Pain Diagnostic Questionnaire–4 Questions; ITT, intent to treat; PP, per protocol; WO, weak opioid; W-TENS, wearable transcutaneous electrical nerve simulation.

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