Advertisement

Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial

  • Author Footnotes
    a Contributed equally.
    S. Reichenbach
    Footnotes
    a Contributed equally.
    Affiliations
    Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland

    Department of Rheumatology and Immunology, Bern University Hospital, Switzerland
    Search for articles by this author
  • Author Footnotes
    a Contributed equally.
    Peter Jüni
    Footnotes
    a Contributed equally.
    Affiliations
    Institute of Health Policy, Management, and Evaluation, Department of Medicine, University of Toronto, Toronto, Canada

    Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada
    Search for articles by this author
  • C.A. Hincapié
    Affiliations
    Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada

    Department of Chiropractic Medicine, Faculty of Medicine, University of Zurich and Balgrist University Hospital, Zurich, Switzerland

    Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland
    Search for articles by this author
  • C. Schneider
    Affiliations
    Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland

    Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
    Search for articles by this author
  • D.N. Meli
    Affiliations
    General Practice, Huttwil, Switzerland
    Search for articles by this author
  • R. Schürch
    Affiliations
    Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland

    CTU Bern, University of Bern, Switzerland

    Department of Entomology, Virginia Tech Polytechnic Institute & State University, Blacksburg, USA
    Search for articles by this author
  • S. Streit
    Affiliations
    Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
    Search for articles by this author
  • C. Lucas
    Affiliations
    Department of Clinical Epidemiology, Biostatistics and Bioinformatics, University of Amsterdam, Faculty of Medicine (AMC), Amsterdam, the Netherlands
    Search for articles by this author
  • C. Mebes
    Affiliations
    Physio Postmarkt AG, Grenchen, Switzerland
    Search for articles by this author
  • A.W.S. Rutjes
    Affiliations
    Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland
    Search for articles by this author
  • B.R. da Costa
    Correspondence
    Address correspondence and reprint requests to: B.R da Costa, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 250 Yonge Street, 6th Floor, Toronto, ON, M5B 2L7, Canada.
    Affiliations
    Institute of Health Policy, Management, and Evaluation, Department of Medicine, University of Toronto, Toronto, Canada

    Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada

    Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
    Search for articles by this author
  • Author Footnotes
    a Contributed equally.
Published:November 22, 2021DOI:https://doi.org/10.1016/j.joca.2021.10.015

      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

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Osteoarthritis and Cartilage
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • National Clinical Guideline Centre (UK)
        Osteoarthritis: Care and Management in Adults. National Institute for Health and Care Excellence (UK), London2014 Feb (PMID: 25340227)
        • Rosemann T.
        • Grol R.
        • Herman K.
        • Wensing M.
        • Szecsenyi J.
        Association between obesity, quality of life, physical activity and health service utilization in primary care patients with osteoarthritis.
        Int J Behav Nutr Phys Activ. 2008; 5: 4
        • Grotle M.
        • Hagen K.B.
        • Natvig B.
        • Dahl F.A.
        • Kvien T.K.
        Prevalence and burden of osteoarthritis: results from a population survey in Norway.
        J Rheumatol. 2008; 35: 677-684
        • Allen R.J.
        Physical agents used in the management of chronic pain by physical therapists.
        Phys Med Rehabil Clin. 2006; 17: 315-345
        • Zhang W.
        • Moskowitz R.W.
        • Nuki G.
        • Abramson S.
        • Altman R.D.
        • Arden N.
        • et al.
        OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.
        Osteoarthritis Cartilage. 2008; 16: 137-162
        • Melzack R.
        • Wall P.D.
        Pain mechanisms: a new theory.
        Science. 1965; 150: 971-979
        • Andersson S.A.
        • Hansson G.
        • Holmgren E.
        • Renberg O.
        Evaluation of the pain suppressive effect of different frequencies of peripheral electrical stimulation in chronic pain conditions.
        Acta Orthop Scand. 1976; 47: 149-157
        • Grimmer K.
        A controlled double blind study comparing the effects of strong Burst Mode TENS and High Rate TENS on painful osteoarthritic knees.
        Aust J Physiother. 1992; 38: 49-56
        • Jamtvedt G.
        • Dahm K.T.
        • Christie A.
        • Moe R.H.
        • Haavardsholm E.
        • Holm I.
        • et al.
        Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews.
        Phys Ther. 2008; 88: 123-136
        • Bjordal J.M.
        • Johnson M.I.
        • Lopes-Martins R.A.
        • Bogen B.
        • Chow R.
        • Ljunggren A.E.
        Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials.
        BMC Muscoskel Disord. 2007; 8: 51
        • Rutjes A.W.
        • Nuesch E.
        • Sterchi R.
        • Kalichman L.
        • Hendriks E.
        • Osiri M.
        • et al.
        Transcutaneous electrostimulation for osteoarthritis of the knee.
        Cochrane Database Syst Rev. 2009; : CD002823
        • Altman R.
        • Asch E.
        • Bloch D.
        • Bole G.
        • Borenstein D.
        • Brandt K.
        • et al.
        Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association.
        Arthritis Rheum. 1986; 29: 1039-1049
        • Kellgren J.H.
        • Lawrence J.S.
        Radiological assessment of osteo-arthrosis.
        Ann Rheum Dis. 1957; 16: 494-502
        • Juni P.
        • Reichenbach S.
        • Trelle S.
        • Tschannen B.
        • Wandel S.
        • Jordi B.
        • et al.
        Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial.
        Arthritis Rheum. 2007; 56: 3610-3619
        • Rakel B.
        • Cooper N.
        • Adams H.J.
        • Messer B.R.
        • Frey Law L.A.
        • Dannen D.R.
        • et al.
        A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment.
        J Pain. 2010; 11: 230-238
        • Bellamy N.
        • Buchanan W.W.
        • Goldsmith C.H.
        • Campbell J.
        • Stitt L.W.
        Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
        J Rheumatol. 1988; 15: 1833-1840
        • Zigmond A.S.
        • Snaith R.P.
        The hospital anxiety and depression scale.
        Acta Psychiatr Scand. 1983; 67: 361-370
        • Pollard B.
        • Dixon D.
        • Dieppe P.
        • Johnston M.
        Measuring the ICF components of impairment, activity limitation and participation restriction: an item analysis using classical test theory and item response theory.
        Health Qual Life Outcome. 2009; 7: 41
        • Dworkin R.H.
        • Turk D.C.
        • Wyrwich K.W.
        • Beaton D.
        • Cleeland C.S.
        • Farrar J.T.
        • et al.
        Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.
        J Pain. 2008; 9: 105-121
        • James K.E.
        • Bloch D.A.
        • Lee K.K.
        • Kraemer H.C.
        • Fuller R.K.
        An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation--a VA cooperative study.
        Stat Med. 1996; 15: 1421-1434
        • Colford Jr., J.M.
        • Rees J.R.
        • Wade T.J.
        • Khalakdina A.
        • Hilton J.F.
        • Ergas I.J.
        • et al.
        Participant blinding and gastrointestinal illness in a randomized, controlled trial of an in-home drinking water intervention.
        Emerg Infect Dis. 2002; 8: 29-36
        • Copay A.G.
        • Subach B.R.
        • Glassman S.D.
        • Polly Jr., D.W.
        • Schuler T.C.
        Understanding the minimum clinically important difference: a review of concepts and methods.
        Spine J. 2007; 7: 541-546
        • da Costa B.R.
        • Reichenbach S.
        • Keller N.
        • Nartey L.
        • Wandel S.
        • Juni P.
        • et al.
        Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis.
        Lancet. 2016; 387: 2093-2105
        • Nuesch E.
        • Trelle S.
        • Reichenbach S.
        • Rutjes A.W.
        • Burgi E.
        • Scherer M.
        • et al.
        The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study.
        BMJ. 2009; 339: b3244
        • Pietrosimone B.G.
        • Saliba S.A.
        • Hart J.M.
        • Hertel J.
        • Kerrigan D.C.
        • Ingersoll C.D.
        Effects of transcutaneous electrical nerve stimulation and therapeutic exercise on quadriceps activation in people with tibiofemoral osteoarthritis.
        J Orthop Sports Phys Ther. 2011; 41: 4-12
        • Juni P.
        • Reichenbach S.
        • Dieppe P.
        Osteoarthritis: rational approach to treating the individual.
        Best Pract Res Clin Rheumatol. 2006; 20: 721-740
        • Altay F.
        • Durmus D.
        • Canturk F.
        Effects of TENS on pain, disability, quality of life and depression in patients with knee osteoarthritis. [Turkish] TENS'in diz osteoartritli hastalarda agri, ozurluluk, yasam kalitesi ve depresyon uzerine etkisi.
        Turk J Rheumatol. 2010; 25: 116-121
        • Atamaz F.C.
        • Durmaz B.
        • Baydar M.
        • Demircioglu O.Y.
        • Iyiyapici A.
        • Kuran B.
        • et al.
        Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study.
        Arch Phys Med Rehabil. 2012; 93: 748-756
        • Cherian J.J.
        • Kapadia B.H.
        • Bhave A.
        • McElroy M.J.
        • Cherian C.
        • Harwin S.F.
        • et al.
        Use of Transcutaneous Electrical Nerve Stimulation Device in Early Osteoarthritis of the Knee.
        2014
        • Eyigor S.
        • Karapolat H.
        • Ibisoglu U.
        • Durmaz B.
        [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study].
        Agri Dergisi. 2008; 20: 32-40
        • Gschiel B.
        • Kager H.
        • Pipam W.
        • Weichart K.
        • Likar R.
        Analgesic efficacy of TENS therapy in patients with gonarthrosis. A prospective, randomised, placebo-controlled, double-blind study. [German] Analgetische effizienz von transkutaner elektrischer nervenstimulation (tens-therapie) bei patienten mit gonarthrose eine prospektive, randomisierte, placebokontrollierte, doppelblinde studie.
        Schmerz. 2010; 24: 494-500
        • Mascarin N.C.
        • Vancini R.L.
        • Andrade M.D.S.
        • Magalhaes E.D.P.
        • De Lira C.A.B.
        • Coimbra I.B.
        Effects of kinesiotherapy, ultrasound and electrotherapy in management of bilateral knee osteoarthritis: prospective clinical trial.
        BMC Muscoskel Disord. 2012; 13
        • Palmer S.
        • Domaille M.
        • Cramp F.
        • Walsh N.
        • Pollock J.
        • Kirwan J.
        • et al.
        Transcutaneous electrical nerve stimulation as an adjunct to education and exercise for knee osteoarthritis: a randomized controlled trial [with consumer summary].
        Arthritis Care Res. 2014; 66: 387-394
        • Pietrosimone B.G.
        • Hart J.M.
        • Saliba S.A.
        • Hertel J.
        • Ingersoll C.D.
        Immediate effects of transcutaneous electrical nerve stimulation and focal knee joint cooling on quadriceps activation.
        Med Sci Sports Exerc. 2009 Jun; 41: 1175-1181 2009
        • Vance C.G.
        • Rakel B.A.
        • Blodgett N.P.
        • DeSantana J.M.
        • Amendola A.
        • Zimmerman M.B.
        • et al.
        Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial.
        Phys Ther. 2012; 92: 898-910
        • Abelson J.
        • Li K.
        • Wilson G.
        • Shields K.
        • Schneider C.
        • Boesveld S.
        Supporting quality public and patient engagement in health system organizations: development and usability testing of the Public and Patient Engagement Evaluation Tool.
        Health Expect. 2016; 19: 817-827
        • Iijima H.
        • Eguchi R.
        • Shimoura K.
        • Yamada K.
        • Aoyama T.
        • Takahashi M.
        Transcutaneous electrical nerve stimulation improves stair climbing capacity in people with knee osteoarthritis.
        Sci Rep. 2020; 10: 7294
        • Pietrosimone B.
        • Luc-Harkey B.A.
        • Harkey M.S.
        • Davis-Wilson H.C.
        • Pfeiffer S.J.
        • Schwartz T.A.
        • et al.
        Using TENS to enhance therapeutic exercise in individuals with knee osteoarthritis.
        Med Sci Sports Exerc. 2020; 52: 2086-2095
        • Kolasinski S.L.
        • Neogi T.
        • Hochberg M.C.
        • Oatis C.
        • Guyatt G.
        • Block J.
        • et al.
        2019 American College of rheumatology/arthritis foundation guideline for the management of osteoarthritis of the hand, hip, and knee.
        Arthritis Rheum. 2020; 72: 220-233
        • Surgeons AAoO
        Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline.
        2nd edn. American Academy of Orthopedic Surgeons, Rosemont, IL 600182013
        • McAlindon T.E.
        • Bannuru R.R.
        • Sullivan M.C.
        • Arden N.K.
        • Berenbaum F.
        • Bierma-Zeinstra S.M.
        • et al.
        OARSI guidelines for the non-surgical management of knee osteoarthritis.
        Osteoarthritis Cartilage. 2014; 22: 363-388
        • Bannuru R.R.
        • Osani M.C.
        • Vaysbrot E.E.
        • Arden N.K.
        • Bennell K.
        • Bierma-Zeinstra S.M.A.
        • et al.
        OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis.
        Osteoarthritis Cartilage. 2019; 27: 1578-1589
        • Fransen M.
        • McConnell S.
        • Harmer A.R.
        • Van der Esch M.
        • Simic M.
        • Bennell K.L.
        Exercise for osteoarthritis of the knee.
        Cochrane Database Syst Rev. 2015; 1: CD004376