{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T05:04:38Z","timestamp":1789707878072,"version":"4.0.1"},"reference-count":41,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To describe the protocol for a randomized controlled trial designed to evaluate the clinical efficacy of penetrating needling compared with cognitive behavioral therapy (CBT) in patients with subjective tinnitus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This protocol describes a proposed assessor- and analyst-blinded, parallel-group randomized controlled trial. A total of 72 participants will be randomized 1:1 to a treatment group receiving penetrating needling plus health education or a control group receiving CBT plus health education. Penetrating needling will be administered five times weekly for two consecutive weeks (10 sessions). The primary outcomes are the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), and a Visual Analogue Scale (VAS) for tinnitus loudness. Secondary outcomes include the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Scale (HAMD), and the Hamilton Anxiety Scale (HAMA). Outcomes will be assessed at baseline, after one week of treatment, after two weeks of treatment, and at a 4-week follow-up (by telephone, online, or in clinic).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>As CBT is an established standard of care, this proposed parallel-group trial is designed to specifically evaluate the efficacy of penetrating needling. The findings of this protocol are expected to provide rigorous, high-quality evidence to determine the viability of penetrating needling as a neuromodulatory alternative for subjective tinnitus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>http:\/\/itmctr.ccebtcm.org.cn\/<\/jats:ext-link>\n                      , ITMCTR2024000264.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fneur.2026.1877858","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T04:36:18Z","timestamp":1789706178000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Study protocol for a randomized controlled trial comparing penetrating needling and cognitive behavioral therapy for subjective tinnitus"],"prefix":"10.3389","volume":"17","author":[{"given":"Shasha","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Otolaryngology, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wanting","family":"Xu","sequence":"additional","affiliation":[{"name":"Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuejun","family":"Guo","sequence":"additional","affiliation":[{"name":"Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qinwei","family":"Fu","sequence":"additional","affiliation":[{"name":"Hospital of Chengdu University of Traditional Chinese Medicine","place":["Chengdu, Sichuan, China"]},{"name":"Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University","place":["Hamilton, ON, Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Liang","sequence":"additional","affiliation":[{"name":"The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Wu","sequence":"additional","affiliation":[{"name":"Guizhou University of Traditional Chinese Medicine","place":["Guiyang, Guizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"633","DOI":"10.1002\/hbm.25676","article-title":"Striatal networks for tinnitus treatment targeting","volume":"43","author":"Hinkley","year":"2022","journal-title":"Hum Brain Mapp"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"413","DOI":"10.1007\/s10162\u2011024\u201100960\u20113","article-title":"The Current State of Tinnitus Diagnosis and Treatment: a Multidisciplinary Expert Perspective","volume":"25","author":"Kleinjung","year":"2024","journal-title":"J Assoc Res Otolaryngol"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"888","DOI":"10.1001\/jamaneurol.2022.2189","article-title":"Global prevalence and incidence of tinnitus: a systematic review and Meta-analysis","volume":"79","author":"Jarach","year":"2022","journal-title":"JAMA Neurol"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"266","DOI":"10.1016\/j.joto.2021.04.001","article-title":"Subjective tinnitus: lesion-induced pathological central homeostasis remodeling","volume":"16","author":"Zhang","year":"2021","journal-title":"J Otol"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1186\/s12955-018-0888-9","article-title":"A narrative synthesis of research evidence for tinnitus-related complaints as reported by patients and their significant others","volume":"16","author":"Hall","year":"2018","journal-title":"Health Qual Life Outcomes"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"811550","DOI":"10.3389\/fnhum.2022.811550","article-title":"Dose-response transcranial electrical stimulation study design: a well-controlled adaptive seamless Bayesian method to illuminate negative valence role in tinnitus perception","volume":"16","author":"Ghodratitoostani","year":"2022","journal-title":"Front Hum Neurosci"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"264","DOI":"10.1080\/13651501.2020.1757117","article-title":"Anxiety sensitivities, anxiety and depression levels, and personality traits of patients with chronic subjective tinnitus: a case-control study","volume":"24","author":"Karaaslan","year":"2020","journal-title":"Int J Psychiatry Clin Pract"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1007\/s12647-026-00924-3","article-title":"Effectiveness of personalized tinnitus masking therapy evaluated using pure tone audiometry: a prospective clinical study","author":"Hassoon","year":"2026","journal-title":"Mapan"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1373390","DOI":"10.3389\/fneur.2024.1373390","article-title":"Modulations of resting-static functional connectivity on insular by electroacupuncture in subjective tinnitus","volume":"15","author":"Zha","year":"2024","journal-title":"Front Neurol"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1038\/s41598-025-29008-z","article-title":"A large-scale, multi-site examination of resting state functional connectivity in tinnitus","volume":"16","author":"Schmidt","year":"2025","journal-title":"Sci Rep"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"219","DOI":"10.3238\/arztebl.m2022.0135","article-title":"Chronic tinnitus","volume":"119","author":"Mazurek","year":"2022","journal-title":"Dtsch Arztebl Int"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"181","DOI":"10.7874\/jao.2023.00416","article-title":"Recent updates on tinnitus management","volume":"27","author":"Lee","year":"2023","journal-title":"J Audiol Otol"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"e35019","DOI":"10.1097\/MD.0000000000035019","article-title":"Network meta-analysis of acupuncture for tinnitus","volume":"102","author":"Ji","year":"2023","journal-title":"Medicine"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"104215","DOI":"10.1016\/j.amjoto.2024.104215","article-title":"Advances in acupuncture treatment for tinnitus","volume":"45","author":"Yu","year":"2024","journal-title":"Am J Otolaryngol"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.3389\/fnhum.2026.1704570","article-title":"Decoding the mechanisms of acupuncture by neuroimaging: an integrated review from networks to molecules","volume":"20","author":"Liu","year":"2026","journal-title":"Front Hum Neurosci"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"e37107","DOI":"10.1097\/MD.0000000000037107","article-title":"Investigating acupoint selection and combinations of acupuncture for primary idiopathic tinnitus using data mining","volume":"103","author":"Huang","year":"2024","journal-title":"Medicine"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1016\/j.jams.2019.05.002","article-title":"Thermal effects of acupuncture by the infrared thermography test in patients with tinnitus","volume":"12","author":"Cai","year":"2019","journal-title":"J Acupunct Meridian Stud"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1186\/1745-6215-13-224","article-title":"Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial","volume":"13","author":"Shi","year":"2012","journal-title":"Trials"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"71","DOI":"10.13702\/j.1000-0607.201210","article-title":"The ancient literature source and flow of the point to point penetration acupuncture method","volume":"47","author":"Li","year":"2022","journal-title":"Zhen Ci Yan Jiu"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"36","DOI":"10.1136\/aim.17.1.36","article-title":"Point-penetration acupuncture: historical development and clinical application","volume":"17","author":"Jun","year":"1999","journal-title":"Acupunct Med"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"648","DOI":"10.13703\/j.0255-2930.20190703-0005","article-title":"Professor FANG Jian-qiao's clinical experiences in the identification and treatment of cranial tinnitus","volume":"40","author":"Ding","year":"2020","journal-title":"Zhongguo Zhen Jiu"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"12","DOI":"10.13703\/j.0255-2930.20230628-0003","article-title":"Exploring the regulatory effect of acupuncture for Ningshen Tongqiao on the functional connectivity between the anterior cingulate cortex and the whole brain in the patients with subjective tinnitus based on fMRI","volume":"44","author":"Zhang","year":"2024","journal-title":"Zhongguo Zhen Jiu"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"143","DOI":"10.1001\/archotol.1996.01890140029007","article-title":"Development of the tinnitus handicap inventory","volume":"122","author":"Newman","year":"1996","journal-title":"Arch Otolaryngol Head Neck Surg"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1590\/S0104-56872005000300004","article-title":"Tinnitus handicap inventory: cross-cultural adaptation to Brazilian Portuguese","volume":"17","author":"Paula Erika Alves","year":"2005","journal-title":"Pro Fono"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"6851","DOI":"10.1080\/09638288.2021.1972172","article-title":"ICF domains covered by the tinnitus questionnaire and tinnitus functional index","volume":"44","author":"van der Wal","year":"2022","journal-title":"Disabil Rehabil"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1097\/MAO.0000000000002070","article-title":"Relationship between tinnitus loudness measure by visual analogue scale and psychoacoustic matching of tinnitus loudness","volume":"40","author":"Raj-Koziak","year":"2019","journal-title":"Otol Neurotol"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1055\/s-0041-1736649","article-title":"Measures of subjective tinnitus: what does visual analog scale stand for?","volume":"33","author":"Shin","year":"2022","journal-title":"J Am Acad Audiol"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1016\/j.sleep.2010.04.020","article-title":"Validation of the Brazilian Portuguese version of the Pittsburgh sleep quality index","volume":"12","author":"Bertolazi","year":"2011","journal-title":"Sleep Med"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"1943","DOI":"10.1007\/s11136-005-4346-x","article-title":"Psychometric evaluation of the Chinese version of the Pittsburgh sleep quality index (CPSQI) in primary insomnia and control subjects","volume":"14","author":"Tsai","year":"2005","journal-title":"Qual Life Res"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"103104","DOI":"10.1016\/j.ajp.2022.103104","article-title":"A Chinese adaptation of six items, self-report Hamilton depression scale: factor structure and psychometric properties","volume":"73","author":"Wang","year":"2022","journal-title":"Asian J Psychiatr"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"384","DOI":"10.1016\/j.jad.2013.04.028","article-title":"Severity classification on the Hamilton depression rating scale","volume":"150","author":"Zimmerman","year":"2013","journal-title":"J Affect Disord"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"429","DOI":"10.1016\/j.jad.2023.01.029","article-title":"Consistency checks to improve measurement with the Hamilton rating scale for anxiety (HAM-A)","volume":"325","author":"Rabinowitz","year":"2023","journal-title":"J Affect Disord"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1016\/0165-0327(88)90072-9","article-title":"The Hamilton anxiety scale: reliability, validity and sensitivity to change in anxiety and depressive disorders","volume":"14","author":"Maier","year":"1988","journal-title":"J Affect Disord"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"e081123","DOI":"10.1136\/bmj-2024-081123","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"389","author":"Hopewell","year":"2025","journal-title":"BMJ"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"e081477","DOI":"10.1136\/bmj-2024-081477","article-title":"SPIRIT 2025 statement: updated guideline for protocols of randomised trials","volume":"389","author":"Chan","year":"2025","journal-title":"BMJ"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"15","DOI":"10.3390\/ijerph8010015","article-title":"Blocked randomization with randomly selected block sizes","volume":"8","author":"Efird","year":"2011","journal-title":"Int J Environ Res Public Health"},{"key":"ref37","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1136\/aim.2009.001370","article-title":"Revised STandards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement","volume":"28","author":"MacPherson","year":"2010","journal-title":"Acupunct Med"},{"key":"ref38","doi-asserted-by":"publisher","first-page":"579","DOI":"10.13703\/j.0255-2930.20220117-k0001","article-title":"Interpretation of China national standard nomenclature and location of Meridian points (GB\/T 12346-2021)","volume":"42","author":"Wu","year":"2022","journal-title":"Zhongguo Zhen Jiu"},{"key":"ref39","doi-asserted-by":"publisher","first-page":"1997","DOI":"10.4103\/1673-5374.172318","article-title":"Acupuncture for ischemic stroke: cerebellar activation may be a central mechanism following Deqi","volume":"10","author":"Li","year":"2015","journal-title":"Neural Regen Res"},{"key":"ref40","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1002\/ohn.1217","article-title":"Estimation of minimal clinically important difference for tinnitus handicap inventory and tinnitus functional index","volume":"173","author":"Engelke","year":"2025","journal-title":"Otolaryngol Head Neck Surg"},{"key":"ref41","doi-asserted-by":"publisher","first-page":"010502","DOI":"10.11613\/BM.2021.010502","article-title":"Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies","volume":"31","author":"Serdar","year":"2021","journal-title":"Biochem Med"}],"container-title":["Frontiers in Neurology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1877858\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T04:36:25Z","timestamp":1789706185000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1877858\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,18]]},"references-count":41,"alternative-id":["10.3389\/fneur.2026.1877858"],"URL":"https:\/\/doi.org\/10.3389\/fneur.2026.1877858","relation":{},"ISSN":["1664-2295"],"issn-type":[{"value":"1664-2295","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,18]]},"article-number":"1877858"}}