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

doi:10.1177/1759720X211066233

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

Ther Adv Musculoskelet Dis. 2022 Jan 18:14:1759720X211066233. doi: 10.1177/1759720X211066233. eCollection 2022.

Authors

Emmanuel Maheu¹, Sandrine Soriot-Thomas², Eric Noel³, Hervé Ganry⁴, Eric Lespessailles⁵, Bernard Cortet⁶

Affiliations

¹ Rheumatology Department, St-Antoine Hospital-APHP, 75011 Paris, FrancePrivate Office, 283, Bd Voltaire, Paris, France.
² Clinical Research Centre and Orthopaedic and Traumatology Surgery Department, CHU Amiens Picardie, Amiens, France.
³ Rheumatologist, Ramsay Santé, Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Lyon, France.
⁴ Hergan Consulting 4U, Amiens, France.
⁵ Rheumatology Department, Regional Hospital of Orleans, University of Orléans, Orléans, France.
⁶ Department of Rheumatology, Centre Hospitalier Universitaire de Lille, 59000 Lille, France.

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.

Associated data

ClinicalTrials.gov/NCT03902340