• Miho Sekiguchi, Takafumi Wakita, Koji Otani, Yoshihiro Onishi, Shunichi Fukuhara, Shin-Ichi Kikuchi, and Shin-ichi Konno.
• *Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Japan †Department of Sociology, Kansai University, Osaka, Japan ‡Institute for Health Outcomes & Process Evaluation Research (iHope International), Kyoto, Japan §Department of Healthcare Epidemiology, Kyoto University, Kyoto, Japan; and ¶Center for Innovative Research for Communities and Clinical Excellence, Fukushima Medical University, Fukushima, Japan.
• Spine. 2014 Nov 1; 39 (23): E1388-93.

Study DesignCross-sectional study.ObjectivesTo test the validity and responsiveness of the lumbar spinal stenosis (LSS)-specific symptom scale (FLS-25 [Fukushima LSS Scale 25]).Summary Of Background DataThe FLS-25, a self-administered questionnaire designed to comprehensively cover various symptoms of LSS, has been developed to address the need to measure symptoms specific to this disorder.MethodsOne hundred sixty-seven patients with confirmed LSS who required conservative therapy were asked to complete a questionnaire including questions regarding walking capacity and the FLS-25. These patients also underwent a lumbar extension test and a walking stress test, which are stress tests designed to objectively evaluate LSS symptoms, to measure standing time, walking distance, and walking time. Relationship between the FLS-25 scores and these external standards was analyzed to evaluate the criterion validity of the FLS-25. The patients underwent the same evaluations after 8 weeks of conservative therapy. The relationship between changes from baseline to week 8 in FLS-25 scores and changes in the 3 external standards was analyzed to evaluate the responsiveness of the FLS-25.ResultsThe distribution of FLS-25 scores among patients was symmetric, and there were no ceiling or floor effects. FLS-25 scores increased as self-reported walking capacity decreased (P=0.006). The mean standing time in the lumbar extension test was 165 (SD=109) seconds, and FLS-25 scores increased as standing time decreased (P=0.003). In the walking stress test, mean walking distance and mean walking time were 213 (SD=154) m and 236 (SD=114) seconds. FLS-25 scores increased as walking distance (P=0.002) and walking time (P=0.054) decreased. Changes from baseline to week 8 in FLS-25 scores correlated with changes in the stress test standing time (P=0.014), walking distance (P<0.001), and walking time (P<0.001).ConclusionThe criterion validity and responsiveness of the FLS-25 were confirmed. The use of FLS-25 in clinical and investigational settings is warranted to monitor patients and evaluate therapeutic efficacy.Level Of Evidence3.

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