Introduction:The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy.Methods/design:This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks.Ethics and dissemination:This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.
Before Chuna manual therapy (CMT), a manual therapy applied in Korean medicine, CMT spinal diagnosis using palpation or X-ray is performed. However, studies on the inter-rater concordance of CMT diagnostic methods, concordance among diagnostic methods, and standard CMT diagnostic methods are scarce. Moreover, no clinical studies have used artificial intelligence (AI) programs for X-ray image-based CMT diagnosis. Therefore, this study sought a feasible and standard CMT spinal diagnostic method and explored the clinical applicability of the CMT-AI program. One hundred participants were recruited, and the concordance within and among different diagnostic modalities was analyzed by dividing them into manual diagnosis (MD), X-ray image-based diagnosis (XRD) by experts and non-experts, and XRD using a CMT-AI program by non-experts. Regarding intra-group concordance, XRD by experts showed the highest concordance (used as a gold standard when comparing inter-group concordance), followed by XRD using the AI program, XRD by non-experts, and then MD. Comparing diagnostic results between the groups, concordance with the gold standard was the highest for XRD using the AI program, followed by XRD by non-experts, and MD. Therefore, XRD is a more reasonable CMT diagnostic method than MD. Furthermore, the clinical applicability of the CMT-AI program is high.
Vertebral landmark labelling on X-ray images is important for objective and quantitative diagnosis. Most studies related to the reliability of labelling focus on the Cobb angle, and it is difficult to find studies describing landmark point locations. Since points are the most fundamental geometric feature that can generate lines and angles, the assessment of landmark point locations is essential. The aim of this study is to provide a reliability analysis of landmark points and vertebral endplate lines with a large number of lumbar spine X-ray images. A total of 1000 pairs of anteroposterior and lateral view lumbar spine images were prepared, and 12 manual medicine experts participated in the labelling process as raters. A standard operating procedure (SOP) was proposed by consensus of the raters based on manual medicine and provided guidelines for reducing sources of error in landmark labelling. High intraclass correlation coefficients ranging from 0.934 to 0.991 verified the reliability of the labelling process using the proposed SOP. We also presented means and standard deviations of measurement errors, which could be a valuable reference for evaluating both automated landmark detection algorithms and manual labelling by experts.
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