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Clinical Focus: Orthopedic and Ligament Injuries

Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Knee Osteoarthritis: A Randomized Controlled Trial

, MD, , ScD, , MD & , MD
Pages 19-28 | Published online: 13 Mar 2015

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Corey W Hunter, Timothy R Deer, Mark R Jones, George C Chang Chien, Ryan S D’Souza, Timothy Davis, Erica R Eldon, Michael F Esposito, Johnathan H Goree, Lissa Hewan-Lowe, Jillian A Maloney, Anthony J Mazzola, John S Michels, Annie Layno-Moses, Shachi Patel, Jeanmarie Tari, Jacqueline S Weisbein, Krista A Goulding, Anikar Chhabra, Jeffrey Hassebrock, Chris Wie, Douglas Beall, Dawood Sayed & Natalie Strand. (2022) Consensus Guidelines on Interventional Therapies for Knee Pain (STEP Guidelines) from the American Society of Pain and Neuroscience. Journal of Pain Research 15, pages 2683-2745.
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L. Tyler Wadsworth, Jeffrey D. Kent & Robert J. Holt. (2016) Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Current Medical Research and Opinion 32:2, pages 241-250.
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Shashank Jain, Niketkumar Patel, Parshotam Madan & Senshang Lin. (2015) Quality by design approach for formulation, evaluation and statistical optimization of diclofenac-loaded ethosomes via transdermal route. Pharmaceutical Development and Technology 20:4, pages 473-489.
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John H Peniston, Morris S Gold, Matthew S Wieman & Lawrence K Alwine. (2013) Tolerability of diclofenac sodium 1% gel with concomitant medications known to interact with diclofenac. Therapeutics and Clinical Risk Management 9, pages 153-159.
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Howard S Smith, Eric J Smith & Benjamin R Smith. (2012) Duloxetine in the management of chronic musculoskeletal pain. Therapeutics and Clinical Risk Management 8, pages 267-277.
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John H Peniston, Morris S Gold, Matthew S Wieman & Lawrence K Alwine. (2012) Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. Clinical Interventions in Aging 7, pages 517-523.
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Christopher M. Herndon. (2012) Topical Delivery of Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis. Journal of Pain & Palliative Care Pharmacotherapy 26:1, pages 18-23.
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Charles E Argoff & F Michael Gloth. (2011) Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients. Therapeutics and Clinical Risk Management 7, pages 393-399.
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Niklas Schuelert, Fiona A Russell & Jason J McDougall. (2011) Topical diclofenac in the treatment of osteoarthritis of the knee. Orthopedic Research and Reviews 3, pages 1-8.
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Sanford H Roth & Philip Fuller. (2011) Diclofenac topical solution compared with oral diclofenac: a pooled safety analysis. Journal of Pain Research 4, pages 159-167.
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Matthew J. Bair & Tamara R. Sanderson. (2011) Coanalgesics for Chronic Pain Therapy: A Narrative Review. Postgraduate Medicine 123:6, pages 140-150.
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Roy D. Altman & Peter J. Fowler. (2011) Pharmacologic Treatment of Knee Osteoarthritis in Athletic Women. The Physician and Sportsmedicine 39:3, pages 39-44.
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John H. Peniston, Morris S. Gold & Lawrence K. Alwine. (2011) An Open-Label, Long-Term Safety and Tolerability Trial of Diclofenac Sodium 1% Gel in Patients with Knee Osteoarthritis. The Physician and Sportsmedicine 39:3, pages 31-38.
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Robert L. Barkin, Stacy J. Barkin, Gordon A. Irving & Allan Gordon. (2011) Management of Chronic Noncancer Pain in Depressed Patients. Postgraduate Medicine 123:5, pages 143-154.
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Sanford H Roth. (2011) Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety. Clinical Interventions in Aging 6, pages 125-131.
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H. Richard Barthel & Robert A. Axford-Gatley. (2010) Topical Nonsteroidal Anti-Inflammatory Drugs for Osteoarthritis. Postgraduate Medicine 122:6, pages 98-106.
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Roy D. Altman & Howard S. Smith. (2010) Opioid Therapy for Osteoarthritis and Chronic Low Back Pain. Postgraduate Medicine 122:6, pages 87-97.
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Veenah Stoll, Jennifer M Jost, Allyson Jack, Timothy Johnson, Sarah Klein, Jake Darbhanga, Adam Hurwitz, Rohit S Mehra & Holly B Waters. (2023) Non-steroidal Anti-inflammatory Drugs and Osteopathic Manipulative Treatment for Pain Management in Patients With Osteoarthritis: A Literature Review. Cureus.
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Nut Koonrungsesomboon, Achariya Churyen, Supanimit Teekachunhatean, Chaichan Sangdee & Nutthiya Hanprasertpong. (2022) A Randomized Controlled Trial of Thai Medicinal Plant-4 Cream versus Diclofenac Gel in the Management of Symptomatic Osteoarthritis of the Knee. Evidence-Based Complementary and Alternative Medicine 2022, pages 1-11.
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Dorji Nidup, Somboon Kietinun, Sunyarn Niempoog & Kusuma Sriyakul. (2020) Efficacy of rtsa-byugs vs diclofenac gel in relieving knee pain of patients with osteoarthritis of the knee. Journal of Health Research 35:5, pages 424-433.
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Vladimir V. Tsurko & Margarita A. Gromova. (2021) Evaluation of topical therapy of patients with osteoarthritis of small joints of the hands with Voltaren® Emulgel® 2% (diclofenac diethylamine 2%). Terapevticheskii arkhiv 93:5.
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Asger Reinstrup Bihlet, Inger Byrjalsen, Lee S. Simon, Dario Carrara, Laetitia Delpy & Caroline Derne. (2020) A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial. Seminars in Arthritis and Rheumatism 50:6, pages 1203-1213.
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Connie Chen, Susan Q. Li, Ting Bao, Lily Zhang, Christina Seluzicki & Jun J. Mao. (2020) A Systematic Review of CheeZheng Pain Relieving Plaster for Musculoskeletal Pain: Implications for Oncology Research and Practice. Integrative Cancer Therapies 19, pages 153473542091893.
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Germain Honvo, Raveendhara R. Bannuru, Olivier Bruyère, Francois Rannou, Gabriel Herrero-Beaumont, Daniel Uebelhart, Cyrus Cooper, Nigel Arden, Philip G. Conaghan, Jean-Yves Reginster, Thierry Thomas & Tim McAlindon. (2019) Recommendations for the Reporting of Harms in Manuscripts on Clinical Trials Assessing Osteoarthritis Drugs: A Consensus Statement from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Drugs & Aging 36:S1, pages 145-159.
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Germain Honvo, Victoria Leclercq, Anton Geerinck, Thierry Thomas, Nicola Veronese, Alexia Charles, Véronique Rabenda, Charlotte Beaudart, Cyrus Cooper, Jean-Yves Reginster & Olivier Bruyère. (2019) Safety of Topical Non-steroidal Anti-Inflammatory Drugs in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis. Drugs & Aging 36:S1, pages 45-64.
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Bill Vicenzino, Peter Lawrenson, Asaduzzaman Khan, Aiofe Stephenson, Luke Heales, Heather A. E. Benson & Anthony Wright. (2019) A randomised pilot equivalence trial to evaluate diamagnetically enhanced transdermal delivery of key ground substance components in comparison to an established transdermal non-steroidal anti-inflammatory formulation in males with prior knee injury. PLOS ONE 14:2, pages e0211999.
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M.S.M. Persson, J. Stocks, D.A. Walsh, M. Doherty & W. Zhang. (2018) The relative efficacy of topical non-steroidal anti-inflammatory drugs and capsaicin in osteoarthritis: a network meta-analysis of randomised controlled trials. Osteoarthritis and Cartilage 26:12, pages 1575-1582.
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Chao Zeng, Jie Wei, Monica S M Persson, Aliya Sarmanova, Michael Doherty, Dongxing Xie, YiLun Wang, Xiaoxiao Li, Jiatian Li, Huizhong Long, Guanghua Lei & Weiya Zhang. (2018) Relative efficacy and safety of topical non-steroidal anti-inflammatory drugs for osteoarthritis: a systematic review and network meta-analysis of randomised controlled trials and observational studies. British Journal of Sports Medicine 52:10, pages 642-650.
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Pamela M. Lai, Agron Collaku & Kenneth Reed. (2017) Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial. Journal of International Medical Research 45:2, pages 647-661.
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Jian-Ying Zhou, Ling Luo, Lin-Lin Zhu, Hai-yan Yin, Qiaofeng Wu, Jia-xi Peng, Cheng-shun Zhang, Peng Lv, Yong Tang & Shu-guang Yu. (2017) Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. BMJ Open 7:4, pages e012879.
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Zhen-han Deng, Chao Zeng, Ye Yang, Yu-sheng Li, Jie Wei, Tuo Yang, Hui Li & Guang-hua Lei. (2015) Topical diclofenac therapy for osteoarthritis: a meta-analysis of randomized controlled trials. Clinical Rheumatology 35:5, pages 1253-1261.
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Raveendhara R. BannuruTimothy E. McAlindonMatthew C. SullivanJohn B. WongDavid M. KentChristopher H. Schmid. (2015) Effectiveness and Implications of Alternative Placebo Treatments. Annals of Internal Medicine 163:5, pages 365-372.
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Mary Lynn McPherson & Nina M. Cimino. (2013) Topical NSAID Formulations. Pain Medicine 14:suppl 1, pages S35-S39.
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Nathan J. Rudin. (2013) Topical Analgesics for Chronic Pain. Current Physical Medicine and Rehabilitation Reports 1:4, pages 315-321.
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Herbert S.B. Baraf, Morris S. Gold, Richard A. Petruschke & Matthew S. Wieman. (2012) Tolerability of Topical Diclofenac Sodium 1% Gel for Osteoarthritis in Seniors and Patients With Comorbidities. The American Journal of Geriatric Pharmacotherapy 10:1, pages 47-60.
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Roy D. Altman & H. Richard Barthel. (2011) Topical Therapies for Osteoarthritis. Drugs 71:10, pages 1259-1279.
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UNA MAKRIS, MINNA KOHLER & LIANA FRAENKEL. (2011) Dr. Makris, et al, reply . The Journal of Rheumatology 38:3, pages 573-573.
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ROY D. ALTMAN. (2011) Safety Advantages of Topical versus Oral Nonsteroidal Antiinflammatory Drugs. The Journal of Rheumatology 38:3, pages 572-572.
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Herbert S.B. Baraf, F. Michael Gloth, H. Richard Barthel, Morris S. Gold & Roy D. Altman. (2011) Safety and Efficacy of Topical Diclofenac Sodium Gel for Knee Osteoarthritis in Elderly and Younger Patients. Drugs & Aging 28:1, pages 27-40.
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