Eun Il-Soo, Kim Hak Sang, Cho Yoon Jae, Goh Tae Sik, Lee Jung Sub
Department of Orthopaedic Surgery, Good Samsun Hospital, Busan, Korea.
Department of Orthopaedic Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, 179 Gudeok-Ro, Seo-Gu, Busan, 49241, Republic of Korea.
J Orthop Surg Res. 2025 Aug 12;20(1):762. doi: 10.1186/s13018-025-06188-y.
The Fukushima Lumbar Spinal Stenosis Scale (FLS-25) is a disease-specific patient-reported outcome measure developed to assess the symptoms and functional impact of lumbar spinal stenosis (LSS). However, no Korean version of the FLS-25 has been validated to date. This study aimed to assess the reliability, validity, and responsiveness of a Korean adaptation of the FLS-25 (K-FLS-25) using a structured cross-cultural adaptation process.
The original FLS-25 questionnaire was translated into Korean following established guidelines for cross-cultural adaptation, including forward translation, synthesis, back-translation, expert committee review, and pretesting. The finalized Korean version (K-FLS-25) was initially administered to 140 consecutive patients diagnosed with LSS. Of these, 123 patients completed both the baseline and follow-up assessments and were included in the final analysis. To evaluate construct validity, participants also completed the validated Korean version of the Oswestry Disability Index (ODI) and a Visual Analog Scale (VAS) for back and leg pain. Reliability was assessed through item-wise agreement using kappa statistics, test-retest reliability via the intraclass correlation coefficient (ICC [2,1]), and internal consistency using Cronbach's α. Construct validity was evaluated by calculating Pearson's correlation coefficients between K-FLS-25, ODI, and VAS scores.
All items of the K-FLS-25 demonstrated substantial agreement, with kappa values exceeding 0.6. The test-retest reliability was excellent (ICC [2,1] = 0.93), and internal consistency was high (Cronbach's α = 0.901). Construct validity was supported by significant Pearson's correlation coefficients between the total and domain scores of K-FLS-25 and the scores of the ODI and VAS for both back and leg pain. As part of cultural adaptation, a prefinal version was tested in 30 Korean-speaking LSS patients, who reported good comprehension without major issues. The final version was confirmed by expert consensus.
The K-FLS-25 was successfully translated and culturally adapted for Korean-speaking patients. It demonstrated excellent reliability, validity, and responsiveness, supporting its suitability as a disease-specific instrument for evaluating symptoms, functional disability, and treatment-related changes in patients with lumbar spinal stenosis in Korea.
福岛腰椎管狭窄症量表（FLS - 25）是一种针对疾病开发的患者报告结局指标，用于评估腰椎管狭窄症（LSS）的症状和功能影响。然而，目前尚未有经过验证的韩语版FLS - 25。本研究旨在通过结构化的跨文化适应过程，评估韩语版FLS - 25（K - FLS - 25）的信度、效度和反应度。
按照跨文化适应的既定指南，将原始的FLS - 25问卷翻译成韩语，包括正向翻译、综合、反向翻译、专家委员会审查和预测试。最终确定的韩语版（K - FLS - 25）最初应用于140例连续诊断为LSS的患者。其中，123例患者完成了基线和随访评估，并纳入最终分析。为评估结构效度，参与者还完成了经过验证的韩语版奥斯威斯利功能障碍指数（ODI）以及背部和腿部疼痛的视觉模拟量表（VAS）。通过使用kappa统计量的逐项一致性评估信度，通过组内相关系数（ICC [2,1]）评估重测信度，并使用Cronbach's α评估内部一致性。通过计算K - FLS - 25、ODI和VAS得分之间的Pearson相关系数来评估结构效度。
K - FLS - 25的所有项目均显示出高度一致性，kappa值超过0.6。重测信度极佳（ICC [2,1] = 0.93），内部一致性较高（Cronbach's α = 0.901）。K - FLS - 25总分及各领域得分与ODI得分以及背部和腿部疼痛的VAS得分之间显著的Pearson相关系数支持了结构效度。作为文化适应的一部分，在30名讲韩语的LSS患者中测试了预终版，他们报告理解良好，没有重大问题。最终版本经专家共识确认。
K - FLS - 25已成功翻译成韩语并进行了文化适应。它表现出出色的信度、效度和反应度，支持其作为评估韩国腰椎管狭窄症患者症状、功能障碍及治疗相关变化的疾病特异性工具的适用性。
