{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T17:42:03Z","timestamp":1791308523665,"version":"4.3.1"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,10,23]],"date-time":"2014-10-23T00:00:00Z","timestamp":1414022400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Tian Medical Inc","award":["12-004TI"],"award-info":[{"award-number":["12-004TI"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Headache"],"published-print":{"date-parts":[[2015,1]]},"abstract":"\n Objective<\/jats:title>\n \n To determine if repetitive sphenopalatine ganglion (\n SPG<\/jats:styled-content>\n ) blocks with 0.5% bupivacaine delivered through the\n T<\/jats:styled-content>\n x360\n \u00ae<\/jats:sup>\n are superior in reducing pain associated with chronic migraine (\n CM<\/jats:styled-content>\n ) compared with saline.\n <\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n \n The\n SPG<\/jats:styled-content>\n is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa (\n PPF<\/jats:styled-content>\n ) in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve. From an anatomical and physiological perspective,\n SPG<\/jats:styled-content>\n blockade may be an effective acute and preventative treatment for\n CM<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Method<\/jats:title>\n \n This was a double\u2010blind, parallel\u2010arm, placebo\u2010controlled, randomized pilot study using a novel intervention for acute treatment in\n CM<\/jats:styled-content>\n . Up to 41 subjects could be enrolled at 2 headache specialty clinics in the\n US<\/jats:styled-content>\n . Eligible subjects were between 18 and 80 years of age and had a history of\n CM<\/jats:styled-content>\n defined by the second edition of the\n I<\/jats:styled-content>\n nternational\n C<\/jats:styled-content>\n lassification of\n H<\/jats:styled-content>\n eadache\n D<\/jats:styled-content>\n isorders appendix definition. They were allowed a stable dose of migraine preventive medications that was maintained throughout the study. Following a 28\u2010day baseline period, subjects were randomized by computer\u2010generated lists of 2:1 to receive 0.5% bupivacaine or saline, respectively. The primary end\u2010point was to compare numeric rating scale scores at pretreatment baseline vs 15 minutes, 30 minutes, and 24 hours postprocedure for all 12 treatments.\n <\/jats:p>\n <\/jats:sec>\n \n \n \n SPG<\/jats:styled-content>\n blockade was accomplished with the\n T<\/jats:styled-content>\n x360\n \u00ae<\/jats:sup>\n , which allows a small flexible soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa into the intranasal space. A 0.3\u2009cc of anesthetic or saline was injected into the mucosa covering the\n SPG<\/jats:styled-content>\n . The procedure is performed similarly in each nostril. The active phase of the study consisted of a series of 12\n SPG<\/jats:styled-content>\n blocks with 0.3\u2009cc of 0.5% bupivacaine or saline provided 2 times per week for 6 weeks. Subjects were re\u2010evaluated at 1 and 6 months postfinal procedure.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The final dataset included 38 subjects, 26 in the bupivacaine group and 12 in the saline group. A repeated measures analysis of variance showed that subjects receiving treatment with bupivacaine experienced a significant reduction in the numeric rating scale scores compared with those receiving saline at baseline (\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20093.78 vs\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20093.18,\n P<\/jats:italic>\n \u2009=\u2009.10), 15 minutes (\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20093.51 vs\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20092.53,\n P<\/jats:italic>\n \u2009<\u2009.001), 30 minutes (\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20093.45 vs\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20092.41,\n P<\/jats:italic>\n \u2009<\u2009.001), and 24 hours after treatment (\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20094.20 vs\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \u2009=\u20092.85,\n P<\/jats:italic>\n \u2009<\u2009.001), respectively.\n H<\/jats:styled-content>\n eadache\n I<\/jats:styled-content>\n mpact\n T<\/jats:styled-content>\n est\u20106 scores were statistically significantly decreased in subjects receiving treatments with bupivacaine from before treatment to the final treatment (\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \n diff<\/jats:sub>\n <\/jats:italic>\n \u2009=\u2009\u22124.52,\n P<\/jats:italic>\n \u2009=\u2009.005), whereas no significant change was seen in the saline group\n (<\/jats:italic>\n \n M<\/jats:italic>\n <\/jats:styled-content>\n \n diff<\/jats:sub>\n <\/jats:italic>\n \u2009=\u2009\u22121.50,\n P<\/jats:italic>\n \u2009=\u2009.13).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n SPG<\/jats:styled-content>\n blockade with bupivacaine delivered repetitively for 6 weeks with the\n T<\/jats:styled-content>\n x360\n \u00ae<\/jats:sup>\n device demonstrates promise as an acute treatment of headache in some subjects with\n CM<\/jats:styled-content>\n . Statistically significant headache relief is noted at 15 and 30 minutes and sustained at 24 hours for\n SPG<\/jats:styled-content>\n blockade with bupivacaine vs saline. The\n T<\/jats:styled-content>\n x360\n \u00ae<\/jats:sup>\n device was simple to use and not associated with any significant or lasting adverse events. Further research on sphenopalatine ganglion blockade is warranted.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/head.12458","type":"journal-article","created":{"date-parts":[[2014,10,23]],"date-time":"2014-10-23T01:56:35Z","timestamp":1414029395000},"page":"101-116","source":"Crossref","is-referenced-by-count":102,"title":["A Double\u2010Blind, Placebo\u2010Controlled Study of Repetitive Transnasal Sphenopalatine Ganglion Blockade With\n T<\/scp>\n x360\n \u00ae<\/sup>\n as Acute Treatment for Chronic Migraine"],"prefix":"10.1111","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4081-8395","authenticated-orcid":false,"given":"Roger","family":"Cady","sequence":"first","affiliation":[{"name":"Headache Care Center Springfield MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Saper","sequence":"additional","affiliation":[{"name":"Michigan Head Pain and Neurological Institute Ann Arbor MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent","family":"Dexter","sequence":"additional","affiliation":[{"name":"Headache Care Center Springfield MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather R.","family":"Manley","sequence":"additional","affiliation":[{"name":"Clinvest Springfield MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,10,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2007.01288.x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04094.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000113747.18760.D2"},{"key":"e_1_2_10_5_1","first-page":"315","volume-title":"Wolff's Headache and Other Head Pain","author":"Silberstein 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