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Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal disorders, but a lack of well-designed randomised controlled trial s (RCTs) mean there is insufficient evidence to prove the efficacy of HPP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study is a two-arm parallel, assessor-blinded, multi-centre, randomised controlled trial. We will enrol 82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC\/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be four follow-up visits 6, 9, 13, and 25\u2009weeks from baseline. The primary end point is 6\u2009weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6. Secondary outcomes will be Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck\u2019s Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This study will assess the efficacy and safety of HPP for chronic TMD compared with PT. This RCT will provide evidence for the efficacy, safety, and economics of HPP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicatrials.gov\">clinicaTrials.gov<\/jats:ext-link>(<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">NCT04087005<\/jats:ext-link>) \/ Clinical Research Information Service (CRIS) (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/cris.nih.go.kr\/cris\/index.jsp\">KCT0004437<\/jats:ext-link>) \/ IRB (JASENG 2017\u201309\u2013002-002, KHNMCOH 2019\u201308-002) \/ Ministry of Food and Drug Safety (No. 31886).<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-020-04442-8","type":"journal-article","created":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T11:04:28Z","timestamp":1592219068000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Jongho","family":"Kim","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoung Sun","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoon Jae","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koh-Woon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae-Heung","family":"Cho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"In-Hyuk","family":"Ha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,6,15]]},"reference":[{"issue":"25","key":"4442_CR1","doi-asserted-by":"publisher","first-page":"2693","DOI":"10.1056\/NEJMra0802472","volume":"359","author":"SJ Scrivani","year":"2008","unstructured":"Scrivani SJ, Keith DA, Kaban LB. 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Int J Oral Maxillofac Surg. 2013;42(3):364\u20138.","journal-title":"Int J Oral Maxillofac Surg"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04442-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-020-04442-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04442-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T17:37:42Z","timestamp":1723052262000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04442-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,15]]},"references-count":58,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4442"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04442-8","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,15]]},"assertion":[{"value":"28 October 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 May 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 June 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study protocol, ICF, all information given to the patients, and other relevant information, have been submitted to and received approval from the Ministry of Food and Drug Safety and from the IRBs which belong to Jaseng Hospital of Korean Medicine and Kyung Hee University Korean Medicine Hospital at Gangdong. All investigators participating in this study will be educated in the tenets of the Helsinki Declaration and the Korean Good Clinical Practice Guidelines, the study plan, and the SOP to protect the patients participating in the trial. All personal information of participants in the trial will be strictly managed under the supervision of the IRBs, and privacy and protection of participants\u2019 personal information will be guaranteed. All data collected from patients who consent to participate in this study will be anonymised, and if requested by other institutions for research purposes, will be provided as an arbitrary code that omits all personal information. Separate approval by an IRB will be required if the data is to be used for purposes other than the current study.Before starting the clinical trial, the investigators will thoroughly explain the study contents and give information about treatment to participants, before obtaining voluntarily signed consent forms. On the consent form, participants will be asked if they agree to use of their data. Participants will also be asked for permission for the research team to share relevant data with people from the hospitals taking part in the research or from regulatory authorities. Participants will be given a copy of the signed consent form. In addition, if personal information is necessary, such as a copy of the participant\u2019s passbook showing travel expenses, this will be explained to the participant, and we will obtain consent to collect such personal information. This trial does not involve collecting biological specimens for storage, so relevant consent will not be necessary.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"525"}}