Elsevier

The Spine Journal

Volume 17, Issue 10, October 2017, Pages 1464-1471
The Spine Journal

Clinical Study
Clinical classification criteria for radicular pain caused by lumbar disc herniation: the radicular pain caused by disc herniation (RAPIDH) criteria

https://doi.org/10.1016/j.spinee.2017.05.005Get rights and content

Abstract

Background Context

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.

Purpose

This study aimed to produce clinical classification criteria to identify patients with radicular pain caused by LDH.

Study Design

The study design was a two-stage process. Phase 1 included a Delphi process and Phase 2 included a cohort study.

Patient Sample

The patient sample included outpatients recruited from spine clinics in five countries.

Outcome Measures

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.

Results

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%).

Conclusions

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.

Introduction

Low back pain (LBP) is a common symptom leading patients to visit primary care and musculoskeletal specialty providers [1]. Many individuals with LBP also report an associated leg pain that may indicate nerve root involvement. Lumbar disc herniation (LDH) is the most frequently identified cause of radicular pain [2]. However, disc herniations may be found on imaging tests of asymptomatic individuals [3]. Guideline recommendations to decrease the use of spinal imaging in patients with acute LBP, including radicular leg pain without signs suggesting serious etiologies, emphasize the role of history and physical examination findings as key to guiding initial management [4], [5], [6]. Therefore, the diagnosis of radicular pain is predominately clinically based.

In musculoskeletal diseases, the need for classification criteria was recognized 30 years ago as an important step to identify and distinguish patients with a specific disease from those without disease to create homogenous groups of patients for clinical or population studies [7]. In the field of LBP, the Quebec Task Force recognized the necessity to differentiate LBP patients with leg pain and neurologic signs from other categories of LBP patients [8]. Although clinicians are trained to identify patients with radicular pain caused by LDH, no consensus has emerged to produce classification criteria for these patients [9]. As a consequence, researchers use a wide range of eligibility criteria leading to a considerable heterogeneity among patients enrolled in these studies [10]. Classification criteria are useful in clinical research to ensure that study participants have the disease in question and that different centers are studying patients with the same clinical condition [11]. When classification criteria are accepted internationally, they can encourage the use of uniform disease definitions and ensure that studies from divergent locations evaluate the same disease entity [12]. For several musculoskeletal diseases (eg, rheumatoid arthritis and spondyloarthropathy), widespread adoption of classification criteria has been a key factor leading to improved patient selection and treatment [13]. The absence of such classification criteria for several low back-related conditions has been identified as a limitation in terms of understanding the physiopathology and evaluating new treatments [9], [10].

In view of the large economic burden related to LBP syndromes [14], there is an urgent need to develop classification criteria for LBP-related syndromes [10]. During a workshop at the 11th Forum for Primary Care Research on Low Back Pain in Boston, MA, a multidisciplinary, international group proposed the development of classification criteria for LBP-related neurologic leg symptoms.

Section snippets

Materials and methods

The present study was designed according to rules defined by Fries for constructing classification criteria [15] and focused on radicular pain caused by LDH and neurogenic claudication (NC) caused by lumbar spinal stenosis. Here, we report on the development and validation of clinical classification criteria for radicular pain caused by LDH.

Delphi process

The literature review and items identified by spine specialists resulted in a list of 236 potential items for spine-related leg pain symptoms and physical examination findings, including 145 associated with radicular pain caused by LDH. The large number of items reflected an inclusive list generation phase with multiple items reflecting small variations among similar concepts (eg, Lasègue sign or SLR test items including five different angles and with three different wordings). In the first

Discussion

A multidisciplinary, international team developed and validated clinical classification criteria for radicular pain caused by LDH. The proposed criteria contained a majority of items relating to the clinician's examination rather than patient-reported symptoms, and differentiated patients with radicular pain caused by LDH from those with LSS or non-NSLBP with referred leg pain. We propose an easy-to-use weighted score of retained items, the RAPIDH criteria, to identify individuals with

Conclusions

The present study proposes clinical classification criteria using a set of five items with good specificity and sensitivity for identifying patients with radicular pain caused by LDH. Although this set of items requires validation in different patients and settings, we believe that such criteria represent an important step in the field of spinal pain research and will contribute to improving the quality of future studies and the evaluation of future treatments.

Acknowledgments

We express our gratitude to all spine experts who participated in the Delphi process and to those who participated in the recruitment of patients. From Belgium: Geneviève Mahieu, consultant, Physical Medicine and Rehabilitation (PMR), CHU Dinant; Agnieszka Gierasimowicz-Fontana, consultant, PMR, CHU Brugmann, Bruxelles. From France: Violaine Folz and Sylvie Rozenberg, rheumatologist and staff physician, respectively, CHU Pitié Salpétrière, Paris; Virginie Martaille and Emilie Ducourau,

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    FDA device/drug status: Not applicable.

    Author disclosures: SG: Nothing to disclose. DSC: Nothing to disclose. KK: Nothing to disclose. FMK: Nothing to disclose. MM: Nothing to disclose. JR: Nothing to disclose. MN: Nothing to disclose. JFK: Nothing to disclose. TDC: Nothing to disclose. JNK: Nothing to disclose. SJA: Nothing to disclose.

    The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

    This study received financial support from an unconditional scientific grant from MSD Switzerland. MSD Switzerland had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Publication of this study was not contingent upon approval from the study sponsor.

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