TY - JOUR
T1 - Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis
T2 - the ETRELKA randomized clinical trial
AU - Reichenbach, S.
AU - Jüni, Peter
AU - Hincapié, C. A.
AU - Schneider, C.
AU - Meli, D. N.
AU - Schürch, R.
AU - Streit, S.
AU - Lucas, C.
AU - Mebes, C.
AU - Rutjes, A. W.S.
AU - da Costa, B. R.
N1 - Funding Information: Peter J?ni serves as unpaid member of steering group or executive committee of trials funded by Abbott Vascular, Astra Zeneca, Biotronik, Biosensors, St. Jude Medical, Terumo and The Medicines Company, has received research grants to the institution from Appili Therapeutics, Astra Zeneca, Biotronik, Biosensors International, Eli Lilly, The Medicines Company, and honoraria to the institution for participation in advisory boards and/or consulting from Amgen, Ava and Fresenius, but has not received personal payments by any pharmaceutical company or device manufacturer.Peter J?ni is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program. Sven Trelle contributed to the design of this trial. Enraf Nonius (https://www.enraf-nonius.nl/) adapted and provided the TENS devices and accessories free of charge. All equipment was returned to Enraf Nonius at end of trial. Enraf-Nonius had no role in study design, conduct, data collection and analysis, decision to publish, or preparation of the manuscript. Funding Information: Peter Jüni is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program . Sven Trelle contributed to the design of this trial. Enraf Nonius ( https://www.enraf-nonius.nl/ ) adapted and provided the TENS devices and accessories free of charge. All equipment was returned to Enraf Nonius at end of trial. Enraf-Nonius had no role in study design, conduct, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2021 Osteoarthritis Research Society International
PY - 2021
Y1 - 2021
N2 - Objective: To determine the effectiveness of TENS at relieving pain and improving physical function as compared to placebo TENS, and to determine its safety, in patients with knee osteoarthritis. Methods: Multi-centre, parallel, 1:1 randomized, double-blind, placebo-controlled clinical trial conducted in six outpatient clinics in Switzerland. We included 220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014. Patients were randomized to 3 weeks of treatment with TENS (n = 108) or placebo TENS (n = 112). Our pre-specified primary endpoint was knee pain at the end of 3-weeks treatment assessed with the WOMAC pain subscale. Secondary outcome measures included WOMAC physical function subscale and safety outcomes. Results: There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference −0.06; 95%CI -0.41 to 0.29; P = 0.74), nor throughout the trial duration (P = 0.98). Subgroup analyses did not indicate an interaction between patient/treatment characteristics and treatment effect on WOMAC pain at the end of treatment (P-interaction ≥0.22). The occurrence of adverse events was similar across groups, with 10.4% and 10.6% of patients reporting events in the TENS and placebo TENS groups, respectively (P = 0.95). No relevant differences were observed in secondary outcomes. Conclusions: TENS does not improve knee osteoarthritis pain when compared to placebo TENS. Therapists should consider other potentially more effective treatment modalities to decrease knee osteoarthritis pain and facilitate strengthening and aerobic exercise. Our findings are conclusive and further trials comparing TENS and placebo TENS in this patient population are not necessary.
AB - Objective: To determine the effectiveness of TENS at relieving pain and improving physical function as compared to placebo TENS, and to determine its safety, in patients with knee osteoarthritis. Methods: Multi-centre, parallel, 1:1 randomized, double-blind, placebo-controlled clinical trial conducted in six outpatient clinics in Switzerland. We included 220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014. Patients were randomized to 3 weeks of treatment with TENS (n = 108) or placebo TENS (n = 112). Our pre-specified primary endpoint was knee pain at the end of 3-weeks treatment assessed with the WOMAC pain subscale. Secondary outcome measures included WOMAC physical function subscale and safety outcomes. Results: There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference −0.06; 95%CI -0.41 to 0.29; P = 0.74), nor throughout the trial duration (P = 0.98). Subgroup analyses did not indicate an interaction between patient/treatment characteristics and treatment effect on WOMAC pain at the end of treatment (P-interaction ≥0.22). The occurrence of adverse events was similar across groups, with 10.4% and 10.6% of patients reporting events in the TENS and placebo TENS groups, respectively (P = 0.95). No relevant differences were observed in secondary outcomes. Conclusions: TENS does not improve knee osteoarthritis pain when compared to placebo TENS. Therapists should consider other potentially more effective treatment modalities to decrease knee osteoarthritis pain and facilitate strengthening and aerobic exercise. Our findings are conclusive and further trials comparing TENS and placebo TENS in this patient population are not necessary.
KW - Osteoarthritis
KW - Pain
KW - Randomized clinical trial
KW - TENS
UR - http://www.scopus.com/inward/record.url?scp=85121635503&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.joca.2021.10.015
DO - https://doi.org/10.1016/j.joca.2021.10.015
M3 - Article
C2 - 34826572
SN - 1063-4584
JO - Osteoarthritis and cartilage
JF - Osteoarthritis and cartilage
ER -