Clinical Classification Criteria for Neurogenic Claudication caused by Lumbar Spinal Stenosis. The N-CLASS criteria

Abstract Background Context Because imaging findings of lumbar spinal stenosis (LSS) may not be associated with symptoms, clinical classification criteria based on patient symptoms and physical examination findings are needed. Purpose The objective of this study was to develop clinical classification criteria that identify patients with neurogenic claudication (NC) caused by LSS. Study Design This study is a two-stage process that includes Phase 1, the Delphi process, and Phase 2, the cross-sectional study. Patient Sample Outpatients were recruited from spine clinics in five countries. Outcome Measure The outcome measure includes items from the patients' history and physical examination. Methods In Phase 1, a list of potential predictors of NC caused by LSS was based on the available literature and was evaluated through a Delphi process involving 17 spine specialists (surgeons and non-surgeons) from eight countries. In Phase 2, 19 different clinical spine specialists from five countries identified patients they classified as having (1) NC caused by LSS, (2) radicular pain caused by lumbar disc herniation (LDH), or (3) non-specific low back pain (NSLBP) with radiating leg pain. The patients completed survey items and the specialists documented the examination signs. Coefficients from general estimating equation models were used to select predictors, to generate a clinical classification score, and to obtain a receiver operating characteristic curve. Conduction of the Delphi process, data management, and statistical analysis were partially supported by an unrestricted grant of less than 15,000 US dollars from Merck Sharp & Dohme. No fees were allocated to participating spine specialists. Results Phase 1 generated a final list of 46 items related to LSS. In Phase 2, 209 patients with leg pain caused by LSS (n=63), LDH (n=89), or NSLBP (n=57) were included. Criteria that independently predicted NC (p 10/19) to obtain a specificity of >90.0% resulted in a sensitivity of 82.0%. Conclusions Clinical criteria independently associated with neurogenic claudication due to LSS were identified. The use of these symptom and physical variables as a classification score for clinical research could improve homogeneity among enrolled patients.