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      Long-term outcomes of occipital nerve stimulation for chronic migraine: a cohort of 53 patients

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          Abstract

          Background

          Chronic migraine affects up to 2 % of the general population and has a substantial impact on sufferers. Occipital nerve stimulation has been investigated as a potentially effective treatment for refractory chronic migraine. Results from randomised controlled trials and open label studies have been inconclusive with little long-term data available.

          Methods

          The long-term efficacy, functional outcome and safety of occipital nerve stimulation was evaluated in an uncontrolled, open-label, prospective study of 53 intractable chronic migraine patients.

          Results

          Fifty-three patients were implanted in a single centre between 2007 and 2013. Patients had a mean age of 47.75 years (range 26–70), had suffered chronic migraine for around 12 years and had failed a mean of 9 (range 4–19) preventative treatments prior to implant. Eighteen patients had other chronic headache phenotypes in addition to chronic migraine. After a median follow-up of 42.00 months (range 6–97) monthly moderate-to-severe headache days (i.e. days on which pain was more than 4 on the verbal rating score and lasted at least 4 h) reduced by 8.51 days ( p < 0.001) in the whole cohort, 5.80 days ( p < 0.01) in those with chronic migraine alone and 12.16 days ( p < 0.001) in those with multiple phenotypes including chronic migraine. Response rate of the whole group (defined as a >30 % reduction in monthly moderate-to-severe headache days) was observed in 45.3 % of the whole cohort, 34.3 % of those with chronic migraine alone and 66.7 % in those with multiple headache types. Mean subjective patient estimate of improvement was 31.7 %. Significant reductions were also seen in outcome measures such as pain intensity (1.34 points, p < 0.001), all monthly headache days (5.66 days, p < 0.001) and pain duration (4.54 h, p < 0.001). Responders showed substantial reductions in headache-related disability, affect scores and quality of life measures. Adverse event rates were favourable with no episodes of lead migration and only one minor infection reported.

          Conclusions

          Occipital nerve stimulation may be a safe and efficacious treatment for highly intractable chronic migraine patients even after relatively prolonged follow up of a median of over 3 years.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s10194-016-0659-0) contains supplementary material, which is available to authorized users.

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          Most cited references38

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          The International Classification of Headache Disorders, 3rd edition (beta version).

          (2013)
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            Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

            An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.
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              Global prevalence of chronic migraine: a systematic review.

              The aim of this review was to summarize population-based studies reporting prevalence and/or incidence of chronic migraine (CM) and to explore variation across studies. A systematic literature search was conducted. Relevant data were abstracted and estimates were subdivided based on the criteria used in each study. Sixteen publications representing 12 studies were accepted. None presented data on CM incidence. The prevalence of CM was 0-5.1%, with estimates typically in the range of 1.4-2.2%. Seven studies used Silberstein-Lipton criteria (or equivalent), with prevalence ranging from 0.9% to 5.1%. Three estimates used migraine that occurred ≥15 days per month, with prevalence ranging from 0 to 0.7%. Prevalence varied by World Health Organization region and gender. This review identified population-based studies of CM prevalence, although heterogeneity across studies and lack of data from certain regions leaves an incomplete picture. Future studies on CM would benefit from an International Classification of Headache Disorders consensus diagnosis that is clinically appropriate and operational in epidemiological studies.
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                Author and article information

                Contributors
                +44 7595900535 , m.matharu@uclmail.net
                Journal
                J Headache Pain
                J Headache Pain
                The Journal of Headache and Pain
                Springer Milan (Milan )
                1129-2369
                1129-2377
                30 July 2016
                30 July 2016
                2016
                : 17
                : 1
                : 68
                Affiliations
                [1 ]Headache Group, Institute of Neurology and The National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG UK
                [2 ]Department of Neurosurgery, Institute of Neurology and The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK
                Article
                659
                10.1186/s10194-016-0659-0
                4967414
                27475100
                ab1d873d-43b6-4326-8bdc-3310cb572c9b
                © The Author(s). 2016

                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.

                History
                : 17 May 2016
                : 22 July 2016
                Funding
                Funded by: FundRef http://dx.doi.org/http://dx.doi.org/10.13039/501100000765, University College London;
                Award ID: Not applicable
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Anesthesiology & Pain management
                chronic migraine,headache,neurostimulation,occipital nerve stimulation

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