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Title
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C2 nerve field stimulation for the treatment of fibromyalgia : a prospective, double-blind, randomized, controlled cross-over study
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Author
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Abstract
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| Background: Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Methods: Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. Results: During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Conclusion: Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. (C) 2015 Elsevier Inc. All rights reserved. |
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Language
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English
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Source (journal)
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Brain stimulation
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Publication
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2015
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ISSN
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1935-861X
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DOI
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10.1016/J.BRS.2015.03.002
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Volume/pages
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8
:4
(2015)
, p. 751-757
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ISI
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000357542100009
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Pubmed ID
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25910427
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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