Sun-Young Park, Yeong-Jae Shin, In-Hyuk Ha, Jung Min Yun, Jun-Su Jang, Sanghun Lee, Mi Hong Yim, Woosu Choi, Hae Sun Suh, Hyuna Yoon, Dahye Ryu, Yeon-Woo Lee, In Heo, Man-Suk Hwang, Eui-Hyoung Hwang, Byung-Cheul Shin
{"title":"在治疗非急性腰背痛患者骨盆生物力学损伤方面，常规护理、简单楚纳手法疗法和复杂楚纳手法疗法的效果比较研究：多中心随机对照试验方案。","authors":"Sun-Young Park, Yeong-Jae Shin, In-Hyuk Ha, Jung Min Yun, Jun-Su Jang, Sanghun Lee, Mi Hong Yim, Woosu Choi, Hae Sun Suh, Hyuna Yoon, Dahye Ryu, Yeon-Woo Lee, In Heo, Man-Suk Hwang, Eui-Hyoung Hwang, Byung-Cheul Shin","doi":"10.1186/s12906-024-04653-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care.</p><p><strong>Methods: </strong>This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments.</p><p><strong>Discussion: </strong>This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis.</p><p><strong>Trial registration: </strong>Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.</p>","PeriodicalId":9128,"journal":{"name":"BMC Complementary Medicine and Therapies","volume":"24 1","pages":"353"},"PeriodicalIF":3.3000,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448296/pdf/","citationCount":"0","resultStr":"{\"title\":\"A comparative effectiveness study of usual care, simple Chuna manual therapy, and complex Chuna manual therapy for the treatment of pelvic biomechanical lesions in patients with non-acute low back pain: a protocol for multicenter, randomized controlled trial.\",\"authors\":\"Sun-Young Park, Yeong-Jae Shin, In-Hyuk Ha, Jung Min Yun, Jun-Su Jang, Sanghun Lee, Mi Hong Yim, Woosu Choi, Hae Sun Suh, Hyuna Yoon, Dahye Ryu, Yeon-Woo Lee, In Heo, Man-Suk Hwang, Eui-Hyoung Hwang, Byung-Cheul Shin\",\"doi\":\"10.1186/s12906-024-04653-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care.</p><p><strong>Methods: </strong>This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments.</p><p><strong>Discussion: </strong>This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis.</p><p><strong>Trial registration: </strong>Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.</p>\",\"PeriodicalId\":9128,\"journal\":{\"name\":\"BMC Complementary Medicine and Therapies\",\"volume\":\"24 1\",\"pages\":\"353\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-10-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448296/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Complementary Medicine and Therapies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12906-024-04653-5\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Complementary Medicine and Therapies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12906-024-04653-5","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
A comparative effectiveness study of usual care, simple Chuna manual therapy, and complex Chuna manual therapy for the treatment of pelvic biomechanical lesions in patients with non-acute low back pain: a protocol for multicenter, randomized controlled trial.
Background: Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care.
Methods: This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments.
Discussion: This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis.
Trial registration: Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.
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