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      The beneficial use of ultramicronized palmitoylethanolamide as add-on therapy to Tapentadol in the treatment of low back pain: a pilot study comparing prospective and retrospective observational arms

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          Abstract

          Background

          This pilot study was designed to compare the efficacy of ultramicronized palmitoylethanolamide (um-PEA) as add-on therapy to tapentadol (TP) with TP therapy only in patients suffering from chronic low back pain (LBP).

          Methods

          This pilot observational study consists in two arms: the prospective arm and the retrospective one. In the prospective arm patients consecutively selected received um-PEA as add-on therapy to TP for 6 months; in the retrospective arm patients were treated with TP only for 6 months. Pain intensity and neuropathic component were evaluated at baseline, during and after 6 months. The degree of disability and TP dosage assumption were evaluated at baseline and after 6 months.

          Results

          Statistical analysis performed with generalized linear mixed model on 55 patients (30 in the prospective group and 25 in the retrospective group) demonstrated that um-PEA as add-on treatment to TP in patients with chronic LBP, in comparison to TP alone, led to a significantly higher reduction in pain intensity, in the neuropathic component, the degree of disability and TP dosage assumption. No serious side effects were observed.

          Conclusion

          Overall, the present findings suggest that um-PEA may be an innovative therapeutic intervention as add-on therapy to TP for the management of chronic LBP with a neuropathic component, as well as to improve patient quality of life. Additionally, this combination treatment allowed a reduction in TP dose over time and did not show any serious side effects.

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          Most cited references 27

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          Role of the immune system in chronic pain.

          During the past two decades, an important focus of pain research has been the study of chronic pain mechanisms, particularly the processes that lead to the abnormal sensitivity - spontaneous pain and hyperalgesia - that is associated with these states. For some time it has been recognized that inflammatory mediators released from immune cells can contribute to these persistent pain states. However, it has only recently become clear that immune cell products might have a crucial role not just in inflammatory pain, but also in neuropathic pain caused by damage to peripheral nerves or to the CNS.
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            Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact.

            Estimates on the epidemiology of chronic non-cancer pain vary widely throughout Europe. It is unclear whether this variation reflects true population differences or methodological factors. Such epidemiological information supports European decision makers in allocating healthcare resources. Pan-Europe epidemiological data about chronic non-cancer pain was obtained using systematic review principles in searching and summarising results. Multiple databases (MEDLINE, EMBASE, Cochrane Library, CRD Databases, and GIN) were systematically searched for primary studies containing epidemiological data on chronic non-cancer pain in Europe excluding studies that solely concerned migraines, headaches and pain associated with specific disease conditions. The studies were prioritised according to quality, recency and validity. Eighteen research questions concerning aspects of chronic pain included: prevalence; incidence; pain treatments, control and compliance; treatment satisfaction; and quality of life and economic impacts. The search yielded 16 619 references and 45 were relevant to Europe. Studies for each question were selected that provided the most recent, representative and valid data. There was a clear lack of studies concerning chronic non-cancer pain in Europe as a whole. The 1-month prevalence of moderate-to-severe non-cancer chronic pain was 19%. Chronic pain significantly impacted on patient-perceived health status, affected everyday activities including economic pursuits and personal relationships, and was significantly associated with depressive symptoms. The majority relied on drugs for pain control and NSAIDs were the most frequent drug choice. Despite pain medications, a large proportion had inadequate pain control. To the authors' knowledge this is the most comprehensive literature review on epidemiological data in this field. It is clear that chronic pain has a dramatic impact on European society. Since chronic non-cancer pain is treated differently from cancer-related pain, the lack of data in this area clearly underlines the need for decision makers in healthcare to gather further epidemiological data.
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              Neuropathic low back pain in clinical practice

               R. Baron,  A. Binder,  N Attal (2016)
              Abstract Background and objective Low back pain (LBP) is one of the most common chronic pain conditions. This paper reviews the available literature on the role of neuropathic mechanisms in chronic LBP and discusses implications for its clinical management, with a particular focus on pharmacological treatments. Databases and data treatment Literature searches were performed in PubMed, key pain congresses and ProQuest Dialog to identify published evidence on neuropathic back pain and its management. All titles were assessed for relevant literature. Results Chronic LBP comprises both nociceptive and neuropathic components, however, the neuropathic component appears under‐recognized and undertreated. Neuropathic pain (NP) is challenging to manage. Many patients with chronic LBP have pain that is refractory to existing treatments. Typically, less than half of patients experience clinically meaningful analgesia with oral pharmacotherapies; these are also associated with risks of adverse effects. Paracetamol and NSAIDs, although widely used for LBP, are unlikely to ameliorate the neuropathic component and data on the use of NP medications such as antidepressants and gabapentin/pregabalin are limited. While there is an unmet need for improved treatment options, recent data have shown tapentadol to have efficacy in the neuropathic component of LBP, and studies suggest that the capsaicin 8% patch and lidocaine 5% medicated plaster, topical analgesics available for the treatment of peripheral NP, may be a valuable additional approach for the management of neuropathic LBP. Conclusions Chronic LBP often has an under‐recognized neuropathic component, which can be challenging to manage, and requires improved understanding and better diagnosis and treatment. What does this review add? Increased recognition and improved understanding of the neuropathic component of low back pain raises the potential for the development of mechanism‐based therapies. Open and retrospective studies suggest that agents like tapentadol and topical analgesics — such as the capsaicin 8% patch and the lidocaine 5% medicated plaster — may be effective options for the treatment of neuropathic low back pain in defined patient groups.
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                Author and article information

                Contributors
                beatrice.passavanti@libero.it
                marco.fiore@unicampania.it
                pasquale.sansone@unicampania.it
                caterina.aurilio@unicampania.it
                potavincenzo@gmail.com
                manlio.barbarisi@unicampania.it
                danielafierroh@gmail.com
                caterina.pace@libero.it
                Journal
                BMC Anesthesiol
                BMC Anesthesiol
                BMC Anesthesiology
                BioMed Central (London )
                1471-2253
                19 December 2017
                19 December 2017
                2017
                : 17
                Affiliations
                [1 ]ISNI 0000 0001 2200 8888, GRID grid.9841.4, Department of Women, Child and General and Specialized Surgery, , University of Campania “Luigi Vanvitelli”, ; 80138 Naples, Italy
                [2 ]ISNI 0000 0001 2200 8888, GRID grid.9841.4, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, , University of Campania “Luigi Vanvitelli”, ; Piazza L. Miraglia, 2, 80138 Naples, Italy
                Article
                461
                10.1186/s12871-017-0461-9
                5735888
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                © The Author(s) 2017

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