{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T23:15:36Z","timestamp":1776294936573,"version":"3.50.1"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2019,6,5]],"date-time":"2019-06-05T00:00:00Z","timestamp":1559692800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"PEACE OF MIND Co. Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10\u2009minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10\u2009minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The primary end point (change in NRS \u00b1 SD at week 8 vs baseline) was \u20130.94\u2009\u00b1\u20091.33 in the AT-02 group and \u20130.22\u2009\u00b1\u20091.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (\u20130.73, 95% confidence interval = \u20131.56 to 0.11, P\u2009=\u20090.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P\u2009=\u20090.039).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/pm\/pnz064","type":"journal-article","created":{"date-parts":[[2019,3,22]],"date-time":"2019-03-22T04:17:35Z","timestamp":1553228255000},"page":"326-332","source":"Crossref","is-referenced-by-count":17,"title":["A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia"],"prefix":"10.1093","volume":"21","author":[{"given":"Hiroshi","family":"Oka","sequence":"first","affiliation":[{"name":"Tokyo Rheumatism Pain Clinic, Tokyo, Japan"},{"name":"Department of Rheumatology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Miki","sequence":"additional","affiliation":[{"name":"Faculty of Health Science, Osaka Yukioka College of Health Science, Osaka, Japan"},{"name":"Orthopaedic Surgery and Rheumatology, Hayaishi Hospital, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iwao","family":"Kishita","sequence":"additional","affiliation":[{"name":"PEACE OF MIND Co., Ltd., Kumamoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David F","family":"Kong","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Uchida","sequence":"additional","affiliation":[{"name":"Japanese Organization for Medical Device Development, Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2019,11,26]]},"reference":[{"key":"2020020801330388900_pnz064-B1","article-title":"Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults","volume":"4","year":"2016","journal-title":"Cochrane 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