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      Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study

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          Abstract

          Introduction

          Back and neck pain are common musculoskeletal disorders. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation with fewer systemic side effects and drug interactions compared with oral NSAIDs. This study assessed efficacy and tolerability of a topical combination of capsaicin + diclofenac to treat acute back/neck pain.

          Methods

          In a randomized, double-blind, controlled, multicenter, parallel group trial, 746 patients were treated twice-daily for 5 days with diclofenac 2% + capsaicin 0.075%, diclofenac 2%, capsaicin 0.075% or placebo. Efficacy assessments included change and area under the curve in pain on movement for the worst procedure (POM WP), change in pressure algometry, and number of patients with decrease in POM WP of ≥ 30% and ≥ 50%. Adverse events (AEs) were recorded.

          Results

          Change in POM WP between baseline and day 2 evening, 1 h after drug application, demonstrates superiority of the combination (− 3.05 cm) versus diclofenac alone (− 2.33 cm) and placebo (− 2.45 cm), but not capsaicin alone (− 3.26 cm). AEs were consistent with known safety profiles.

          Conclusion

          Capsaicin alone and capsaicin + diclofenac showed superior benefit compared with placebo. However, diclofenac alone demonstrated efficacy comparable with placebo, and therefore its addition to capsaicin added no increased pain relief over capsaicin alone.

          Trial registration

          ClinicalTrials.gov identifier; NCT02700815.

          Electronic supplementary material

          The online version of this article (10.1007/s40122-020-00161-9) contains supplementary material, which is available to authorized users.

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          Most cited references21

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          The epidemiology of neck pain.

          Neck pain is becoming increasingly common throughout the world. It has a considerable impact on individuals and their families, communities, health-care systems, and businesses. There is substantial heterogeneity between neck pain epidemiological studies, which makes it difficult to compare or pool data from different studies. The estimated 1 year incidence of neck pain from available studies ranges between 10.4% and 21.3% with a higher incidence noted in office and computer workers. While some studies report that between 33% and 65% of people have recovered from an episode of neck pain at 1 year, most cases run an episodic course over a person's lifetime and, thus, relapses are common. The overall prevalence of neck pain in the general population ranges between 0.4% and 86.8% (mean: 23.1%); point prevalence ranges from 0.4% to 41.5% (mean: 14.4%); and 1 year prevalence ranges from 4.8% to 79.5% (mean: 25.8%). Prevalence is generally higher in women, higher in high-income countries compared with low- and middle-income countries and higher in urban areas compared with rural areas. Many environmental and personal factors influence the onset and course of neck pain. Most studies indicate a higher incidence of neck pain among women and an increased risk of developing neck pain until the 35-49-year age group, after which the risk begins to decline. The Global Burden of Disease 2005 Study is currently making estimates of the global burden of neck pain in relation to impairment and activity limitation, and results will be available in 2011. 2011 Elsevier Ltd. All rights reserved.
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            Effect sizes of non-surgical treatments of non-specific low-back pain.

            Numerous randomized trials have been published investigating the effectiveness of treatments for non-specific low-back pain (LBP) either by trials comparing interventions with a no-treatment group or comparing different interventions. In trials comparing two interventions, often no differences are found and it raises questions about the basic benefit of each treatment. To estimate the effect sizes of treatments for non-specific LBP compared to no-treatment comparison groups, we searched for randomized controlled trials from systematic reviews of treatment of non-specific LBP in the latest issue of the Cochrane Library, issue 2, 2005 and available databases until December 2005. Extracted data were effect sizes estimated as Standardized Mean Differences (SMD) and Relative Risk (RR) or data enabling calculation of effect sizes. For acute LBP, the effect size of non-steroidal anti-inflammatory drugs (NSAIDs) and manipulation were only modest (ES: 0.51 and 0.40, respectively) and there was no effect of exercise (ES: 0.07). For chronic LBP, acupuncture, behavioral therapy, exercise therapy, and NSAIDs had the largest effect sizes (SMD: 0.61, 0.57, and 0.52, and RR: 0.61, respectively), all with only a modest effect. Transcutaneous electric nerve stimulation and manipulation had small effect sizes (SMD: 0.22 and 0.35, respectively). As a conclusion, the effect of treatments for LBP is only small to moderate. Therefore, there is a dire need for developing more effective interventions.
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              Topical analgesics in the management of acute and chronic pain.

              Oral analgesics are commonly prescribed for the treatment of acute and chronic pain, but these agents often produce adverse systemic effects, which sometimes are severe. Topical analgesics offer the potential to provide the same analgesic relief provided by oral analgesics but with minimal adverse systemic effects. This article describes the results of a systematic review of the efficacy of topical analgesics in the management of acute and chronic pain conditions. A literature search of MEDLINE/PubMed was conducted using the keywords topical analgesic AND chronic pain OR acute pain OR neuropathic pain and focused only on individual clinical trials published in English-language journals. The search identified 92 articles, of which 65 were eligible for inclusion in the review. The most commonly studied topical analgesics were nonsteroidal anti-inflammatory drugs (n=27), followed by lidocaine (n=9), capsaicin (n=6), amitriptyline (n=5), glyceryl trinitrate (n=3), opioids (n=2), menthol (n=2), pimecrolimus (n=2), and phenytoin (n=2). The most common indications were acute soft tissue injuries (n=18), followed by neuropathic pain (n=17), experimental pain (n=6), osteoarthritis and other chronic joint-related conditions (n=5), skin or leg ulcers (n=5), and chronic knee pain (n=2). Strong evidence was identified for the use of topical diclofenac and topical ibuprofen in the treatment of acute soft tissue injuries or chronic joint-related conditions, such as osteoarthritis. Evidence also supports the use of topical lidocaine in the treatment of postherpetic neuralgia and diabetic neuropathy. Currently, limited evidence is available to support the use of other topical analgesics in acute and chronic pain.
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                Author and article information

                Contributors
                robert1.lange@sanofi.com
                Journal
                Pain Ther
                Pain Ther
                Pain and Therapy
                Springer Healthcare (Cheshire )
                2193-8237
                2193-651X
                27 March 2020
                27 March 2020
                June 2020
                : 9
                : 1
                : 279-296
                Affiliations
                [1 ]GRID grid.27593.3a, ISNI 0000 0001 2244 5164, Institute for Cardiology and Sports Medicine, , German Sport University Cologne, ; Cologne, Germany
                [2 ]GRID grid.417924.d, Consumer Health Care, , Sanofi-Aventis, ; Paris, France
                [3 ]GRID grid.420061.1, ISNI 0000 0001 2171 7500, Boehringer Ingelheim Pharma GmbH & Co KG, ; Ingelheim am Rhein, Germany
                [4 ]GRID grid.420214.1, Consumer Health Care, Medical Affairs, , Sanofi-Aventis Deutschland GmbH, ; Frankfurt, Germany
                [5 ]GRID grid.420214.1, Consumer Health Care, Global Medical Affairs, , Sanofi-Aventis Deutschland GmbH, ; Frankfurt, Germany
                Article
                161
                10.1007/s40122-020-00161-9
                7203310
                32221866
                8efbb78b-0816-4bec-9e4a-eb072a4a1122
                © The Author(s) 2020

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 5 February 2020
                Funding
                Funded by: Boehringer Ingelheim Pharma GmbH & Co KG (GER)
                Funded by: Sanofi-Aventis Deutschland GmbH
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2020

                acute back pain,acute neck pain,capsaicin,dermatologic agents,diclofenac,pain intensity reduction,pain on movement,safety

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