Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study
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Argoff CE. Topical analgesics in the management of acute and chronic pain. Mayo Clin Proc. 2013;88:195–205.
Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–37.
Casser HR, Seddigh S, Rauschmann M. Acute lumbar back pain. Investigation, differential diagnosis, and treatment. Dtsch Arztebl Int. 2016;113:223–34.
O’Sullivan P, Lin E. Acute low back pain: beyond physical therapies. Pain Manag Today. 2014;1:8–13.
Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013;14:250–9.
Ferrari R, Russell AS. Regional musculoskeletal conditions: neck pain. Best Pract Res Clin Rheumatol. 2003;17:57–70.
Hoy D, March L, Woolf A, et al. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73:1309–15.
Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010;24:783–92.
Roelofs PDDM, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database Syst Rev. 2008;1:CD000396.
Keller A, Hayden J, Bombardier C, van Tulder M. Effect sizes of non-surgical treatments of non-specific low-back pain. Eur Spine J. 2007;16:1776–888.
French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006;1:CD004750.
Higashi Y, Kiuchi T, Furuta K. Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: a randomized, double-blind, parallel-group, placebocontrolled, multicenter study. Clin Ther. 2010;32:34–433.
French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006;2006:Cd004750.
Garra G, Singer AJ, Leno R, et al. Heat or cold packs for neck and back strain: a randomized controlled trial of efficacy. Acad Emerg Med. 2010;17:484–9.
Okada K, Yamaguchi T, Minowa K, Inoue N. The influence of hot pack therapy on the blood flow in masseter muscles. J Oral Rehabil. 2005;32:480–6.
Warnecke JM, Wendt T, Schak M, Schak M, Schiffer T, Kohl-Bareis M. Evaluation of haemoglobin changes of skin and muscle tissue of the calf induced by topical application of a nonivamide/nicoboxil cream [abstract]. Naunyn Schmiedebergs Arch Pharmacol. 2011;383(Suppl 1):P312.
Chrubasik S, Weiser T, Beime B. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytother Res. 2010;24:1877–85.
Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012;9:CD010111.
Blahova Z, Holm JC, Weiser T, Richter E, Trampisch M, Akarachkova E. Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain—a randomized, placebo-controlled trial. J Pain Res. 2016;9:1221–300.
Gaubitz M, Schiffer T, Holm C, Richter E, Pisternick-Ruf W, Weiser T. Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back—a randomized, controlled trial. Eur J Pain. 2016;20:263–73.
Zacher J, Altman R, Bellamy N, et al. Topical diclofenac and its role in pain and inflammation: an evidence-based review. Curr Med Res Opin. 2008;24:925–50.
O'Neill J, Brock C, Olesen AE, Andresen T, Nilsson M, Dickenson AH. Unravelling the mystery of capsaicin: a tool to understand and treat pain. Pharmacol Rev. 2012;64:939–71.
Anand P, Bley K. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth. 2011;107:490–502.
Capsaicin and diclofenac (topical). 2019. https://www.drugs.com/mtm/capsaicin-and-diclofenac-topical.html. Accessed Jan 2020.
Diclofenac (2016). In: Sweetman SC, editor. Martindale: the complete drug reference. [Online]. London: Pharmaceutical Press; 2016. https://www.micromedexsolutions.com/micromedex2/librarian. Accessed January 2020.
Fang JY, Fang CL, Hong CT, Chen HY, Lin TY, Wei HM. Capsaicin and nonivamide as novel skin permeation enhancers for indomethacin. Eur J Pharm Sci. 2001;12:195–203.
Degim IT, Uslu A, Hadgraft J, Atay T, Akay C, Cevheroglu S. The effects of azone and capsaicin on the permeation of naproxen through human skin. Int J Pharm. 1999;179:21–5.
Clinical trial: NCT 03074162. https://clinicaltrials.gov/ct2/show/NCT03074162. Accessed Jan 2020.
Boehringer Ingelheim. Clinical study synopsis for public discosure. 2018. https://trials.boehringer-ingelheim.com/public/trial_results_documents/1358/_english_13582c9774171pdf.pdf#page=1. Accessed Jan 2020.
Guedes V, Castro JP, Brito I. Topical capsaicin for pain in osteoarthritis: a literature review. Reumatología Clínica (English Edition). 2018;14:40–5.
Investigator’s Brochure diclofenac and capsaicin for the short-term treatment of pain in the neck and back area associated with tense muscle. Version 1. 2015.
ABC Heat Cream. Summary of product characteristics. 2013.
European Medicines Agency (EMEA) Committee for medicinal products for human use (CHMP): guideline on clinical development of fixed combination medicinal products (London, 19 February 2009, doc. ref. CHMP/EWP/240/95 rev. 1). https://www.emea.europa.eu. Accessed Jan 2020.