{"title":"评估SOLIO Alfa Cure Plus装置治疗腰痛的有效性：一项随机对照研究。","authors":"Hadari Yotam, Pesah Galia, Goor-Aryeh Itay, Ungar Lior","doi":"10.1186/s13018-024-05441-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn't require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected.</p><p><strong>Methods: </strong>randomized, single blinded, controlled trial.</p><p><strong>Measures: </strong>Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober's test. Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.</p><p><strong>Results: </strong>We observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04).</p><p><strong>Conclusion: </strong>We concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result.</p><p><strong>Trial registration: </strong>The clinical trials registration is 8475-21-SMC.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"20 1","pages":"76"},"PeriodicalIF":2.8000,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748835/pdf/","citationCount":"0","resultStr":"{\"title\":\"Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study.\",\"authors\":\"Hadari Yotam, Pesah Galia, Goor-Aryeh Itay, Ungar Lior\",\"doi\":\"10.1186/s13018-024-05441-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn't require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected.</p><p><strong>Methods: </strong>randomized, single blinded, controlled trial.</p><p><strong>Measures: </strong>Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober's test. Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.</p><p><strong>Results: </strong>We observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04).</p><p><strong>Conclusion: </strong>We concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result.</p><p><strong>Trial registration: </strong>The clinical trials registration is 8475-21-SMC.</p>\",\"PeriodicalId\":16629,\"journal\":{\"name\":\"Journal of Orthopaedic Surgery and Research\",\"volume\":\"20 1\",\"pages\":\"76\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-01-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748835/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Orthopaedic Surgery and Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13018-024-05441-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Orthopaedic Surgery and Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13018-024-05441-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study.
Background: Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn't require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected.
Methods: randomized, single blinded, controlled trial.
Measures: Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober's test. Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.
Results: We observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04).
Conclusion: We concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result.
Trial registration: The clinical trials registration is 8475-21-SMC.
期刊介绍：
Journal of Orthopaedic Surgery and Research is an open access journal that encompasses all aspects of clinical and basic research studies related to musculoskeletal issues.
Orthopaedic research is conducted at clinical and basic science levels. With the advancement of new technologies and the increasing expectation and demand from doctors and patients, we are witnessing an enormous growth in clinical orthopaedic research, particularly in the fields of traumatology, spinal surgery, joint replacement, sports medicine, musculoskeletal tumour management, hand microsurgery, foot and ankle surgery, paediatric orthopaedic, and orthopaedic rehabilitation. The involvement of basic science ranges from molecular, cellular, structural and functional perspectives to tissue engineering, gait analysis, automation and robotic surgery. Implant and biomaterial designs are new disciplines that complement clinical applications.
JOSR encourages the publication of multidisciplinary research with collaboration amongst clinicians and scientists from different disciplines, which will be the trend in the coming decades.
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