Classification criteria are recommended for diseases that lack specific biomarkers to improve homogeneity in clinical research studies. Because imaging evidence of lumbar disc herniations (LDHs) may not be associated with symptoms, clinical classification criteria based on patient symptoms and physical examination findings are required.
This study aimed to produce clinical classification criteria to identify patients with radicular pain caused by LDH.
The study design was a two-stage process. Phase 1 included a Delphi process and Phase 2 included a cohort study.
The patient sample included outpatients recruited from spine clinics in five countries.
The outcome measures were items from history and physical examination.
Materials and Methods
In Phase 1, 17 spine experts participated in a Delphi process to select symptoms and signs suggesting radicular pain caused by LDH. In Phase 2, 19 different clinical experts identified patients they confidently classified as presenting with (1) radicular pain caused by LDH, (2) neurogenic claudication (NC) caused by lumbar spinal stenosis, or (3) non-specific low back pain (NSLBP) with referred leg pain. Patients completed survey items and specialists documented examination signs. A score to predict radicular pain caused by LDH was developed based on the coefficients of the multivariate model. An unrestricted grant of less than US$15,000 was received from MSD: It was used to support the conception of the Delphi, data management, and statistical analysis. No fees were allocated to participating spine specialists.
Phase 1 generated a final list of 74 potential symptoms and signs. In Phase 2, 209 patients with pain caused by LDH (89), NC (63), or NSLBP (57) were included. Items predicting radicular pain caused by LDH (p<.05) were monoradicular leg pain distribution, patient-reported unilateral leg pain, positive straight leg raise test <60° (or femoral stretch test), unilateral motor weakness, and asymmetric ankle reflex. The score had an AUC of 0.91. An easy-to-use weighted set of criteria with similar psychometric characteristics is proposed (specificity 90.4%, sensitivity 70.6%).
Classification criteria for identifying patients with radicular pain caused by LDH are proposed. Their use could improve the homogeneity of patients enrolled in clinical research studies.