Summary
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.
Keywords
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Article info
Publication history
Published online: November 22, 2021
Accepted:
October 27,
2021
Received:
March 17,
2021
Identification
Copyright
© 2021 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
