We prospectively evaluated the association between the diagnosis of LSS and clinical information, including the history and physical examination of patients with leg symptoms. This study was performed in six university hospitals, ten medical centers, and sixty eight hospitals and clinics affiliated with university hospitals or medical centers during July and September in 2004. We enrolled consecutive patients older than 20 years of age with primary symptoms of pain or numbness in the legs. We excluded patients who have been treated by some medical practices within one year before examination. Patients with cervical myelopathy, previous surgery, degenerative scoliosis (defined as lateral tilting of more than 10 degrees) and inflammatory disorders were also excluded. This study included 250 patients who complained of leg symptoms, including cases of LSS (n = 165), lumbar disc herniation (n = 61), diabetic neuropathy (n = 13), and peripheral vascular disease (n = 11) (Table 3). The study was approved by the institutional review board of each study institution as necessary. Written informed consent was obtained from the all patients. The patients gave informed consent and then answered the SSHQ. The following steps were taken to reach a final diagnosis for each of the enrolled patients (Figure 1). In the first step, at each institution the orthopedic physician who saw a patient made the clinical diagnosis based on the history, physical examination, and radiographic findings. In addition, to verify the diagnosis made by each physician, six board-certified spine surgeons approved by the Japanese Board of Spine Surgery also made a diagnosis for each patient based on the clinical information and findings of the MRI. The opinions of six board-certified spine surgeons approved by the Japanese Board of Spine Surgery were used as the gold standard for diagnosis of LSS. The radicular type was characterized by symptoms of pain, burning, numbness, and paresthesias following a specific dermatome with radiological evidence of the responsible nerve root compression, which was confirmed if intermittent claudication was abolished following single nerve root infiltration. Patients of the cauda equina type presented some bilateral symptoms related to cauda equina compression syndrome with less dermatomal-specific neurogenic claudication and radiological evidence of cauda equina compression.
The sensitivity, specificity, likelihood ratio, and area under the receiver operating characteristic (ROC) curve were estimated. 217 patients classified by investigators as suffering from lower back pain without a significant change in symptoms were given the SSHQ two weeks later during an outpatient visit, and the test-retest reliability over two weeks was investigated in these patients.
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