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      A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain

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          Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain.


          Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POM WP (POM triggering highest pain score at baseline [worst procedure]) between baseline and the morning of day 2. Key secondary endpoints included POM WP area under curve (AUC) between baseline and the morning of day 4 (POM WPAUC 72h) and day 6 (POM WPAUC 120h).


          In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POM WP, with an adjusted mean reduction of 1.998 (standard error [SE]: 0.1042) between baseline and day 2 for ibuprofen, 1.869 (SE: 0.1030) for ibuprofen + caffeine and 1.712 (SE: 0.1422) for placebo. Similar results were observed for POM WPAUC 72h and POM WPAUC 120h. Safety and tolerability was as expected.


          A decrease in lower back/neck pain, indicated by reduced POM WP, was shown in all active treatment arms; however, treatment effects were small versus placebo. Ibuprofen plus caffeine was not superior to ibuprofen alone or placebo for the treatment of acute lower back/neck pain in this setting.

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          Most cited references 25

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          The epidemiology of neck pain.

           R Meersman,  R Torre,  D Hoy (2010)
          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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            Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial.

            Regular paracetamol is the recommended first-line analgesic for acute low-back pain; however, no high-quality evidence supports this recommendation. We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo, in patients with low-back pain.
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              Caffeine as an analgesic adjuvant.

              Thirty clinical studies involving more than 10,000 patients conducted during the last 20 years have been analyzed to assess the value of caffeine as an analgesic adjuvant. Although most studies included patients with postpartum uterine cramping or episiotomy pain, some involved patients with pain from oral surgery or headache. In 21 of 26 studies, the relative potency estimates of an analgesic with caffeine to an analgesic without caffeine is greater than one. The pooled relative potency estimates in each of several major categories of combination analgesics are significantly greater than one. The overall pooled relative potency estimate is 1.41, with 95% confidence limits of 1.23 to 1.63; that is, to obtain the same amount of response from an analgesic without caffeine requires a dose that is approximately 40% greater than one with caffeine.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                23 September 2019
                : 12
                : 2771-2783
                [1 ]Institute of Cardiology and Sports Medicine, Department of Preventive and Rehabilitative Sports Medicine, German Sport University Cologne , Cologne, Germany
                [2 ]Consumer Health Care, Global Medical Head, Sanofi-Aventis , Paris, France
                [3 ]Consumer Health Care, Global Medical Affairs, Sanofi-Aventis Deutschland GmbH , Frankfurt am Main, Germany
                [4 ]Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH , Frankfurt am Main, Germany
                Author notes
                Correspondence: Thomas WeiserConsumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH , Industriepark Höchst, Frankfurt am Main65926GermanyTel +49 693 053 9966Email thomas.weiser@sanofi.com
                © 2019 Predel et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 4, Tables: 3, References: 27, Pages: 13
                Original Research

                Anesthesiology & Pain management

                acute neck pain, acute back pain, caffeine, ibuprofen


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