Knee osteoarthritis (KOA) is a frequent disease for which therapeutic possibilities are limited. In current recommendations, the first-line analgesic is acetaminophen. However, low efficacy of acetaminophen, frequently leads to the use of weak opioids (WO) despite their poor tolerance, especially in elderly patients. The primary objective was to compare the analgesic efficacy and safety of a new wearable transcutaneous electrical nerve stimulation (W-TENS) to weak opioids (WO) in the treatment of moderate to severe, nociceptive, chronic pain in knee osteoarthritis patients. ArthroTENS study is a phase 3, non-inferiority, multicentric, prospective, randomized, single-blinded for primary efficacy outcome, controlled, in 2-parallel groups, clinical study comparing W-TENS versus WO over a 3-month controlled period with an additional, optional, non-controlled, 3-month follow-up for patients in W-TENS group. The co-primary outcome was KOA pain intensity (PI) at month 3 and the number of adverse events (AEs) over 3 months.Introduction and Objective
Materials and Methods
The purpose of this study was to evaluate the
effect of various non-operative modalities of treatment (transcutaneous
electrical nerve stimulation (TENS); neuromuscular electrical stimulation
(NMES); insoles and bracing) on the pain of osteoarthritis (OA)
of the knee. We conducted a systematic review according to the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses guidelines to identify
the therapeutic options which are commonly adopted for the management
of osteoarthritis (OA) of the knee. The outcome measurement tools used in the different studies were
the visual analogue scale and The Western Ontario and McMaster Universities
Arthritis Index pain index: all pain scores were converted to a
100-point scale. A total of 30 studies met our inclusion criteria: 13 on insoles,
seven on TENS, six on NMES, and four on bracing. The standardised
mean difference (SMD) in pain after treatment with TENS was 1.796,
which represented a significant reduction in pain. The significant
overall effect estimate for NMES on pain was similar to that of
TENS, with a SMD of 1.924. The overall effect estimate of insoles
on pain was a SMD of 0.992. The overall effect of bracing showed
a significant reduction in pain of 1.34. Overall, all four non-operative modalities of treatment were
found to have a significant effect on the reduction of pain in OA
of the knee. This study shows that non-operative physical modalities of treatment
are of benefit when treating OA of the knee. However, much of the
literature reviewed evaluates studies with follow-up of less than
six months: future work should aim to evaluate patients with longer
follow-up. Cite this article:
