{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T23:26:54Z","timestamp":1787095614512,"version":"build-2736575974"},"reference-count":36,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82301129"],"award-info":[{"award-number":["82301129"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Natural Science Foundation of Sichuan Province of China - Youth Fund Project","award":["2025ZNSFSC1586"],"award-info":[{"award-number":["2025ZNSFSC1586"]}]},{"name":"Clinical Research Project of West China Hospital of Stomatology, Sichuan University","award":["LCYJ-2023-YY-2"],"award-info":[{"award-number":["LCYJ-2023-YY-2"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Back and Musculoskeletal Rehabilitation"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Transcutaneous electrical nerve stimulation (TENS) is a non-invasive pain therapy with few adverse events (AEs) reporting. Despite updated CONSORT Harms 2022 standards, no study has evaluated AE documentation quality using it in TENS research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This meta-epidemiological study aimed to (1) assess the safety profile of TENS, (2) evaluate the quality of AE reporting in randomized controlled trials (RCTs), (3) identify factors associated with reporting quality, and (4) examine changes in reporting practices following the publication of the CONSORT Harms 2022 guideline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched PubMed, CENTRAL, and Cochrane Library for RCTs reporting TENS-related adverse events. Quality was assessed using the CONSORT Harms 2022 checklist. Mann\u2013Whitney U test was used to investigate whether there was a significant difference between the reporting quality of AE before and after the publication of the checklist. Multivariable linear regression identified factors associated with overall CONSORT score (OCS) and AE documentation quality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Seventy four studies were included with a mean AE reporting compliance of 64.2%. Higher OCS (p\u2009&lt;\u20090.001), larger sample size (p\u2009&lt;\u20090.05), governmental funding (p\u2009&lt;\u20090.05), and diverse funding sources (p\u2009&lt;\u20090.05) were significantly associated with better AE reporting quality. Studies published after the release of the CONSORT Harms 2022 guideline had significantly higher reporting scores than those published earlier (p\u2009&lt;\u20090.05).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The CONSORT Harms 2022 guideline has had a measurable impact on AE reporting quality in TENS trials. The observed frequency of AEs underscores the need for robust safety monitoring protocols in this therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10538127261440640","type":"journal-article","created":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T12:20:03Z","timestamp":1775823603000},"page":"1599-1608","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Assessing transcutaneous electrical nerve stimulation safety and adverse event reporting quality: A meta-epidemiologic study"],"prefix":"10.1177","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-7403-6316","authenticated-orcid":false,"given":"Yihang","family":"Li","sequence":"first","affiliation":[{"name":"State Key Laboratory of Oral Diseases &amp; National Center for Stomatology &amp; National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Li","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral Diseases &amp; National Center for Stomatology &amp; National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haolun","family":"Yang","sequence":"additional","affiliation":[{"name":"Rehabilitation Medicine Center, Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liming","family":"Zhang","sequence":"additional","affiliation":[{"name":"Rehabilitation Medicine Center, Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2175-0970","authenticated-orcid":false,"given":"Xin","family":"Xiong","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral Diseases &amp; National Center for Stomatology &amp; National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,4,10]]},"reference":[{"key":"e_1_3_3_2_2","first-page":"130","article-title":"Transcutaneous electrical nerve stimulation","volume":"9","author":"Johnson MI","year":"2009","unstructured":"Johnson MI, Jones I. Transcutaneous electrical nerve stimulation. Continuing Educ Anaesthesia Critical Care Pain 2009; 9: 130\u2013135.","journal-title":"Continuing Educ Anaesthesia Critical Care Pain"},{"key":"e_1_3_3_3_2","first-page":"90","article-title":"The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery","volume":"33","author":"Akutay S","year":"2025","unstructured":"Akutay S, Y\u00fcceler Ka\u00e7maz H, Ceyhan \u00d6. The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery. Support Care Cancer 2025; 33: 90.","journal-title":"Support Care Cancer"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1586\/ern.11.48"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S493162"},{"key":"e_1_3_3_6_2","unstructured":"Harmonisation ICo. Clinical safety data management: Definitions and standards for expedited reporting (ICH E2A). Report no. CPMP\/ICH\/377\/95. European Medicines Evaluation Agency 1995."},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1155\/2018\/9715142"},{"key":"e_1_3_3_8_2","article-title":"The effects of electrode placement on analgesia using transcutaneous electrical nerve stimulation for primary dysmenorrhea: a single-blind randomized controlled clinical trial","volume":"15","author":"Camilo FM","year":"2023","unstructured":"Camilo FM, Bossini PS, Driusso P, et al. The effects of electrode placement on analgesia using transcutaneous electrical nerve stimulation for primary dysmenorrhea: a single-blind randomized controlled clinical trial. Cureus 2023; 15: e39326.","journal-title":"Cureus"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1155\/2024\/6866549"},{"key":"e_1_3_3_10_2","volume-title":"StatPearls","author":"Teoli D","year":"2024","unstructured":"Teoli D, Dua A, An J. Transcutaneous electrical nerve stimulation. In: StatPearls. Treasure Island, FL: StatPearls Publishing, 2024."},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.3892\/etm.2020.9305"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2021.06.011"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.330"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0020124"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajodo.2010.05.018"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/bjs\/znad004"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.7717\/peerj.15412"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.54029\/2023kif"},{"key":"e_1_3_3_19_2","first-page":"135","article-title":"Evaluation of the readability of turkish internet based patient education materials related to \u201clow back pain.\u201d","volume":"36","author":"Ozduran E","year":"2022","unstructured":"Ozduran E, Erkin Y, Hanci V, et al. Evaluation of the readability of turkish internet based patient education materials related to \u201clow back pain.\u201d. Dokuz Eyl\u00fcl \u00dcniversitesi T\u0131p Fak\u00fcltesi Dergisi 2022; 36: 135\u2013150.","journal-title":"Dokuz Eyl\u00fcl \u00dcniversitesi T\u0131p Fak\u00fcltesi Dergisi"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000041780"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.30621\/jbachs.1018824"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1996.03540080059030"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.15.1987"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050020"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijsu.2011.10.001"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-141-10-200411160-00009"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-073725"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.874829"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2024.111406"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1111\/joor.13824"},{"key":"e_1_3_3_32_2","first-page":"364","article-title":"The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey","volume":"92","author":"Sollaci LB","year":"2004","unstructured":"Sollaci LB, Pereira MG. The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey. J Med Libr Assoc 2004; 92: 364\u2013367. PMID: 15243643.","journal-title":"J Med Libr Assoc"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.brs.2022.09.003"},{"key":"e_1_3_3_34_2","doi-asserted-by":"publisher","DOI":"10.1002\/nau.20958"},{"key":"e_1_3_3_35_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.49.3981"},{"key":"e_1_3_3_36_2","article-title":"Critical appraisal of methodological quality and completeness of reporting in Chinese social science systematic reviews with meta-analysis: a systematic review","volume":"21","author":"Guo L","year":"2025","unstructured":"Guo L, Miller S, Zhou W, et al. Critical appraisal of methodological quality and completeness of reporting in Chinese social science systematic reviews with meta-analysis: a systematic review. Campbell Syst Rev 2025; 21: e70014.","journal-title":"Campbell Syst Rev"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2016.07.006"}],"container-title":["Journal of Back and Musculoskeletal Rehabilitation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10538127261440640","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10538127261440640","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10538127261440640","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T23:20:07Z","timestamp":1787095207000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10538127261440640"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,10]]},"references-count":36,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1177\/10538127261440640"],"URL":"https:\/\/doi.org\/10.1177\/10538127261440640","relation":{},"ISSN":["1053-8127","1878-6324"],"issn-type":[{"value":"1053-8127","type":"print"},{"value":"1878-6324","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,10]]}}}