Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial
Abstract Background Non-specific low back pain (NLBP) is a major global socioeconomic burden, and the prevalence of NLBP is still on the rise. At present, there is no ideal drug to cure this disease. This may be the reason why patients often use complementary therapies. Among them, extracorporeal sh...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Journal of Orthopaedic Surgery and Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13018-022-03146-w |
| _version_ | 1798005319480115200 |
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| author | Yongfu Fan Feilai Liu Mengna Li Xiaodi Ruan Mingli Wu Kaiqi Su Jing Gao Xiaodong Feng |
| author_facet | Yongfu Fan Feilai Liu Mengna Li Xiaodi Ruan Mingli Wu Kaiqi Su Jing Gao Xiaodong Feng |
| author_sort | Yongfu Fan |
| collection | DOAJ |
| description | Abstract Background Non-specific low back pain (NLBP) is a major global socioeconomic burden, and the prevalence of NLBP is still on the rise. At present, there is no ideal drug to cure this disease. This may be the reason why patients often use complementary therapies. Among them, extracorporeal shock wave therapy (ESWT) has gradually received more attention and has become the main treatment method for NLBP. The purpose of this study is to provide scientific evidence for the effect and safety of meridian theory-based ESWT on NLBP. Objective This study aims to evaluate the effect and safety of meridian theory-based ESWT on NLBP. This study will also provide more high-quality experimental evidence for the clinical application of meridian theory-based ESWT for the treatment of NLBP in future. Methods The study design is a single-blind, multi-center, randomized controlled trial. 66 patients with NLBP, aged 18 to 60 years, will be randomly divided into two groups: the experimental group (N = 33), which will receive meridian theory-based ESWT application, and the control group (N = 33) which will receive conventional ESWT treatment. These two applications will be carried out twice a week for two weeks. The primary outcome will be the Visual Analog Scale (VAS), and the secondary outcomes will be Oswestry Disability Index (ODI), Surface Electromyography (sEMG), and Patient Health Questionnaire-15 (PHQ-15). All outcomes will be evaluated at baseline and after the intervention (7 days, 14 days). Discussion Results of this trial will contribute to providing rigorous clinical evidence for the efficacy and security of meridian theory-based ESWT for NLBP. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100051049. Registered on 10 September 2021, http://www.chictr.org.cn/showproj.aspx?proj=46316 . |
| first_indexed | 2024-04-11T12:38:23Z |
| format | Article |
| id | doaj.art-074f6be36be94fdea21ca74d69af7924 |
| institution | Directory Open Access Journal |
| issn | 1749-799X |
| language | English |
| last_indexed | 2024-04-11T12:38:23Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj.art-074f6be36be94fdea21ca74d69af79242022-12-22T04:23:34ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2022-05-011711710.1186/s13018-022-03146-wObservation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trialYongfu Fan0Feilai Liu1Mengna Li2Xiaodi Ruan3Mingli Wu4Kaiqi Su5Jing Gao6Xiaodong Feng7Henan University of Chinese MedicineRehabilitation Center, The First Affiliated Hospital of Henan University of Chinese MedicineInstitute of Pain Medicine and Special Environmental Medicine, Nantong UniversityHenan University of Chinese MedicineRehabilitation Center, The First Affiliated Hospital of Henan University of Chinese MedicineRehabilitation Center, The First Affiliated Hospital of Henan University of Chinese MedicineRehabilitation Center, The First Affiliated Hospital of Henan University of Chinese MedicineHenan University of Chinese MedicineAbstract Background Non-specific low back pain (NLBP) is a major global socioeconomic burden, and the prevalence of NLBP is still on the rise. At present, there is no ideal drug to cure this disease. This may be the reason why patients often use complementary therapies. Among them, extracorporeal shock wave therapy (ESWT) has gradually received more attention and has become the main treatment method for NLBP. The purpose of this study is to provide scientific evidence for the effect and safety of meridian theory-based ESWT on NLBP. Objective This study aims to evaluate the effect and safety of meridian theory-based ESWT on NLBP. This study will also provide more high-quality experimental evidence for the clinical application of meridian theory-based ESWT for the treatment of NLBP in future. Methods The study design is a single-blind, multi-center, randomized controlled trial. 66 patients with NLBP, aged 18 to 60 years, will be randomly divided into two groups: the experimental group (N = 33), which will receive meridian theory-based ESWT application, and the control group (N = 33) which will receive conventional ESWT treatment. These two applications will be carried out twice a week for two weeks. The primary outcome will be the Visual Analog Scale (VAS), and the secondary outcomes will be Oswestry Disability Index (ODI), Surface Electromyography (sEMG), and Patient Health Questionnaire-15 (PHQ-15). All outcomes will be evaluated at baseline and after the intervention (7 days, 14 days). Discussion Results of this trial will contribute to providing rigorous clinical evidence for the efficacy and security of meridian theory-based ESWT for NLBP. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100051049. Registered on 10 September 2021, http://www.chictr.org.cn/showproj.aspx?proj=46316 .https://doi.org/10.1186/s13018-022-03146-wExtracorporeal shock wave therapy (ESWT)Meridian theoryNon-specific low back pain (NLBP)Clinical trial |
| spellingShingle | Yongfu Fan Feilai Liu Mengna Li Xiaodi Ruan Mingli Wu Kaiqi Su Jing Gao Xiaodong Feng Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial Journal of Orthopaedic Surgery and Research Extracorporeal shock wave therapy (ESWT) Meridian theory Non-specific low back pain (NLBP) Clinical trial |
| title | Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial |
| title_full | Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial |
| title_fullStr | Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial |
| title_full_unstemmed | Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial |
| title_short | Observation of curative effect on meridian theory-based extracorporeal shock wave therapy for non-specific low back pain: study protocol for a randomized controlled trial |
| title_sort | observation of curative effect on meridian theory based extracorporeal shock wave therapy for non specific low back pain study protocol for a randomized controlled trial |
| topic | Extracorporeal shock wave therapy (ESWT) Meridian theory Non-specific low back pain (NLBP) Clinical trial |
| url | https://doi.org/10.1186/s13018-022-03146-w |
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