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Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids
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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777341/ https://www.ncbi.nlm.nih.gov/pubmed/35069809 http://dx.doi.org/10.1177/1759720X211066233 |
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author | Maheu, Emmanuel Soriot-Thomas, Sandrine Noel, Eric Ganry, Hervé Lespessailles, Eric Cortet, Bernard |
author_facet | Maheu, Emmanuel Soriot-Thomas, Sandrine Noel, Eric Ganry, Hervé Lespessailles, Eric Cortet, Bernard |
author_sort | Maheu, Emmanuel |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-8777341 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-87773412022-01-22 Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids Maheu, Emmanuel Soriot-Thomas, Sandrine Noel, Eric Ganry, Hervé Lespessailles, Eric Cortet, Bernard Ther Adv Musculoskelet Dis Original Research 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 SAGE Publications 2022-01-18 /pmc/articles/PMC8777341/ /pubmed/35069809 http://dx.doi.org/10.1177/1759720X211066233 Text en © The Author(s), 2022 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Research Maheu, Emmanuel Soriot-Thomas, Sandrine Noel, Eric Ganry, Hervé Lespessailles, Eric Cortet, Bernard Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids |
title | Wearable transcutaneous electrical nerve stimulation (actiTENS®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
title_full | Wearable transcutaneous electrical nerve stimulation (actiTENS®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
title_fullStr | Wearable transcutaneous electrical nerve stimulation (actiTENS®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
title_full_unstemmed | Wearable transcutaneous electrical nerve stimulation (actiTENS®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
title_short | Wearable transcutaneous electrical nerve stimulation (actiTENS®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
title_sort | wearable transcutaneous electrical nerve stimulation (actitens®) is
effective and safe for the treatment of knee osteoarthritis pain: a randomized
controlled trial versus weak opioids |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777341/ https://www.ncbi.nlm.nih.gov/pubmed/35069809 http://dx.doi.org/10.1177/1759720X211066233 |
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