TitleWearable Transcutaneous Electrical Nerve Stimulation More Effective Than Weak Opioids for Knee OA Pain
By Erika Powers
VIRTUAL -- June 9, 2021 -- Wearable transcutaneous electrical nerve stimulation was more effective and better tolerated than weak opioids in the treatment of moderate-to-severe nociceptive knee osteoarthritis (OA) pain, according to a study presented at the Virtual 2021 Annual Meeting of the European League Against Rheumatism (EULAR).
“In knee osteoarthritis recommendations, the first pharmacological analgesic line is paracetamol,” said Emmanuel Maheu, MD, Hospital Saint-Antoine Ap-Hp, Paris, France. “However, its low efficacy frequently leads to the use of weak opioids despite their poor tolerance, especially in elderly patients. Wearable transcutaneous electrical nerve stimulation should represent an interesting non-pharmacological alternative to weak opioids.”
The phase 3 ArthroTENS study, patients were randomised to a wearable transcutaneous electrical nerve stimulation group or a weak opioid prescription group (ie, codeine, opium powder, and tramadol, with or without paracetamol) for 3 months. A total of 110 patients (55 per group) were randomised and 48/55 (87.3%) and 44/55 (80.0%) patients, respectively, completed the 3-month follow-up.
In the wearable transcutaneous electrical nerve stimulation group, users received high (100 Hz) and low (2 Hz) frequency stimulations that were delivered with standardised positioning electrodes via an advanced mobile app.
All patients were aged older than 55 years and had failed to achieve relief from knee OA pain with non-opioid analgesics, including non-steroidal anti-inflammatory drugs.
The coprimary endpoints were efficacy, mean pain intensity, and safety during the 3-month follow-up period. A non-inferiority analysis was performed on the primary efficacy endpoint using a predefined non-inferiority margin (0.825-point) on pain intensity, below the minimal clinically significant improvement.
“Since the 95% confidence interval of the between-treatments difference was below 0 in the ITT [intent-to-treat] population, a planned superiority analysis was performed showing that wearable transcutaneous electrical nerve stimulation was significantly superior to weak opioids at month 3 for pain intensity (P = .0124).
In addition, the number of adverse events (AEs) was significantly lower in the electrical nerve stimulation group than in the weak opioids group (7 vs 26; P
Thirty-nine (70.9%) patients wished to extend wearable transcutaneous electrical nerve stimulation treatment for 3 additional months.
“Only 1 patient discontinued this additional period and results obtained at month 3 remained stable at month 6,” said Dr. Mahe.
[Presentation title: Wearable Transcutaneous Electrical Nerve Stimulation Demonstrated Better Efficacy and Safety Than Weak Opioids in the Treatment of Moderate to Severe, Chronic Nociceptive Pain in Knee Osteoarthritis. A Randomized, Controlled, Non-Inferiority Trial. Abstract POS0279]