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Diagnostics
Protocol
Diagnostic utility of diagnostic investigations to identify neuropathic pain in low back-related leg pain: protocol for a systematic review
  1. Jai Mistry1,2,
  2. David M Walton3,
  3. Tim Noblet4,
  4. Benjamin Bowling2,
  5. Nicola R Heneghan5,
  6. Alison B Rushton6
  1. 1 Western University, London, Ontario, Canada
  2. 2 St Georges Hospital NHS Foundation Trust, London, UK
  3. 3 School of Physical Therapy, Western University, London, Ontario, Canada
  4. 4 Physiotherapy, St Georges Hospital NHS Foundation Trust, London, UK
  5. 5 School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK
  6. 6 School of Physical Therapy, Western University Faculty of Health Sciences, London, Ontario, Canada
  1. Correspondence to Dr Nicola R Heneghan; n.heneghan{at}bham.ac.uk

Abstract

Introduction Neuropathic pain in low back-related leg pain has gained increasing interest in contemporary research. Identification of neuropathic pain in low back-related leg pain is essential to inform precision management. Diagnostic investigations are commonly used to identify neuropathic pain in low back-related leg pain; yet the diagnostic utility of these investigations is unknown. This systematic review aims to investigate the diagnostic utility of diagnostic investigations to identify neuropathic pain in low back-related leg pain.

Methods and analysis This protocol has been designed and reported in accordance with the Cochrane Handbook for Diagnostic Test Accuracy studies, Centre for Reviews and Dissemination and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols checklist, respectively. The search strategy will involve two independent reviewers searching electronic databases (CINAHL, EMBASE, MEDLINE, Web of Science, Cochrane Library, AMED, Pedro), key journals (Spine, The Clinical Journal of Pain, PAIN, European Journal of Pain, The Journal of Pain, Musculoskeletal Science and Practice) and grey literature (British National Bibliography for report literature, OpenGrey, EThOS) from inception to 31 July 2023 to identify studies. Studies evaluating the diagnostic accuracy of diagnostic investigation to identify neuropathic pain in patients with low back-related leg pain will be eligible, studies not written in English will be excluded. The reviewers will extract the data from included studies, assess risk of bias (Quality Assessment of Diagnostic Accuracy Studies 2) and determine confidence in findings (Grading of Recommendations, Assessment, Development and Evaluation guidelines). Methodological heterogeneity will be assessed to determine if a meta-analysis is possible. If pooling of data is not possible then a narrative synthesis will be done.

Ethics and dissemination Ethical approval is not required. Findings will be published in a peer-reviewed journal, presented at relevant conferences and shared with the Patient Partner Advisor Group at Western University, Canada.

PROSPERO registration number CRD42023438222.

  • Diagnostic Imaging
  • Back pain
  • Musculoskeletal disorders
  • Spine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-078392

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • This review will add to the growing body of literature investigating the identification of neuropathic pain in low back-related leg pain.

    • The protocol is reported in line with the Cochrane Handbook for Diagnostic Test Accuracy studies and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols checklist.

    • Two independent reviewers will be involved at each stage: screening of eligible studies, data extraction, assessment of risk of bias and overall quality of evidence.

    • Known heterogeneity identified from scoping searches suggests that pooling of data may not be possible.

    • Language bias may occur due to the exclusion of non-English articles, resulting in reduced generalisability of findings.

    Introduction

    Low back pain (LBP) is the leading cause of years lived with disability worldwide.1 Individuals with LBP commonly present with associated concomitant leg pain.2 Increased reliance on healthcare resources and poorer health-related outcomes have been found in those with low back-related leg pain (LBLP) when compared with those with LBP alone.3 Neuropathic pain in LBLP has gained increasing interest in contemporary research due to the burden it places on the individual and wider society.4 Neuropathic pain is commonly reported in patients with LBLP with prevalence estimates ranging between 48% and 74%.5 Identification of neuropathic pain in LBLP is essential as international treatment recommendations (pharmacological, invasive procedures) differ for those with LBLP and neuropathic pain (sciatica) compared with those with LBLP alone.6–9 The primary issue concerning the identification of neuropathic pain in LBLP is the absence of a gold standard (eg, test, battery of tests, investigations) and an accepted reference standard to inform diagnosis.

    Various methods have been employed to identify neuropathic pain in LBLP including self-report screening tools,10 11 clusters of patient history and physical testing items12 13 and diagnostic investigations (eg, imaging).14 A recent systematic review investigated the diagnostic utility of clinical investigations (patient history, clinical examination and screening tool data) to identify neuropathic pain in LBLP.15 The diagnostic utility of diagnostic investigations, defined as any instrumented-based diagnostic test (eg, imaging, laboratory test, biopsies and neurophysiology), was not included in this review. Low to moderate level evidence was identified in support of the Standardised Evaluation of Pain tool and a cluster of eight assessment items (age: 16–40 years, duration of disease <15 days, presence of paroxysmal pain, pain worse in leg than back, typical dermatomal distribution, worse on coughing/sneezing/straining, finger to floor distance ≥25 cm and presence of paresis).15 Indirectness, in the included studies, was identified due to the large variation in terminology used to define neuropathic pain in LBLP. Furthermore, heterogeneity of reference standards was evident (including expert opinion, imaging and surgery), therefore, the primary diagnostic data must be interpreted with caution.

    Consensus studies have been conducted in response to the uncertainty highlighted in contemporary research. An expert derived list of clinical indicators was initially developed by Smart et al 16 to identify neuropathic pain mechanisms in musculoskeletal pain, and this list was developed further following an updated study focusing on the identification of neuropathic pain in LBLP.17 Findings revealed a list of eight clinical indicators that are proposed to increase the index of suspicion for the presence of neuropathic pain in LBLP.17 Stronger recommendations would require further support for diagnostic utility of these indicators. Therefore, a reference standard is needed, against which the clinical indicators can be tested. The International Association for the Study of Pain (IASP) Special Interest Group on Neuropathic Pain proposed a grading system, (revised in 2016), to guide decisions based on the level of certainty (possible, probable and definite) with which neuropathic pain can be determined in an individual. In order to satisfy the ‘definite’ criteria, diagnostic investigation/s confirming a lesion or disease of the somatosensory nervous system are required, alongside history and examination findings.18 Diagnostic investigations have been defined by IASP as any instrumented-based diagnostic test intended to identify a lesion or disease of the somatosensory nervous system (imaging, laboratory test, biopsies and neurophysiology).18 However, it is unclear what diagnostic investigations or combination of such should be used in the case of diagnosis of neuropathic pain for LBLP. The aforementioned diagnostic investigations when placed in a clinical pathway are usually placed at the end following history taking and physical examination. The results of these investigations can increase the clinicians index of suspicion that neuropathic pain is present, and therefore, aid the decision-making regarding onward management.

    This systematic review will investigate the diagnostic utility of diagnostic investigations in the identification of neuropathic pain in LBLP. Diagnostic investigations will be the index test and compared against a reference standard (including surgery, expert opinion, assessment findings and diagnostic investigations).

    Aim

    To synthesise evidence investigating the diagnostic utility of diagnostic investigations to identify neuropathic pain in LBLP.

    Method and analysis

    This systematic review protocol has been designed and reported in line with The Cochrane Handbook for Diagnostic Test Accuracy studies, Centre for Reviews and Dissemination (CRD, 2009) and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols checklist. A previous systematic review, conducted by the same research team, has informed the methods of this protocol.15

    Patient and public involvement

    Patients and the public have informed the conception of this review as part of an existing programme of research related to lumbar spinal surgery for LBLP. The study was proposed to the spinal pain research Patient Partner Advisory Group in the School of Physical Therapy at Western University, Canada. Following completion of the systematic review, the results will be presented back to the same group to discuss the findings and to compare them to their own experiences. These discussions may lead to the to the development of future research projects.

    Eligibility criteria

    Types of studies

    Any study design will be considered for inclusion if evaluating diagnostic accuracy of diagnostic investigations to identify neuropathic pain in LBLP. Studies must include diagnostic accuracy data (specificity, sensitivity, likelihood ratios (LRs) and predictive values (PVs)). Diagnostic investigations do not include physical examination tests such as the straight leg raise or slump test.

    Participants

    Studies evaluating diagnostic accuracy of diagnostic investigations in adult patients (age>18 years) with LBLP.

    Index test

    The index test investigation consisted of diagnostic investigations. Diagnostic investigations will be defined as any instrumented-based diagnostic test intended to identify a lesion or disease of the somatosensory nervous system (imaging, laboratory test, biopsies and neurophysiology).18

    Target condition

    Diagnostic studies were included if the aim of the diagnostic test was to identify neuropathic pain in LBLP.

    Reference standards

    We included studies where the diagnostic investigation was compared with a reference standard including: (1) surgery, (2) diagnostic investigations, (3) expert opinion and (4) subjective/objective examination items.

    Studies not written in English will be excluded.

    Search methods for identification of studies

    Electronic searches

    Each electronic database (CINAHL, EMBASE, MEDLINE, Web of Science, Cochrane Library, AMED and Pedro) will be searched from database inception to 31 July 2023 using database-specific search strategies. There will be no geographical restriction. The search strategy was developed by the lead author (JM) and reviewed by a specialist librarian at Western University and coauthors to ensure quality. The search strategy has been informed by a previous published review by Mistry et al 15 with previously used key terms patient history, clinical examination and screening tools replaced with diagnostic investigations (imaging, laboratory test, biopsies and neurophysiology). See MEDLINE search strategy in box 1, search strategy was adapted for other databases and resources (online supplemental file 1).

    Supplemental material

    Box 1

    MEDLINE OvidSP search strategy 1948—31 July 2023

    1. diagnostic accuracy.mp. or “Sensitivity and Specificity”/

    2. diagnostic utility.mp.

    3. exp “Reproducibility of Results”/ or diagnostic reliability.mp.

    4. 1 or 2 or 3

    5. diagnostic investigations.mp.

    6. diagnostic imaging.mp. or exp Diagnostic Imaging/

    7. exp Magnetic Resonance Imaging/ or exp Diffusion Magnetic Resonance Imaging/ or imaging.mp.

    8. exp Neurophysiology/ or neurophysiology.mp.

    9. nerve conduction test.mp. or exp Neural Conduction/

    10. exp Biopsy/ or skin biopsy.mp.

    11. exp Genetic Testing/ or genetic test.mp.

    12. exp Tomography, X-Ray Computed/

    13. laboratory test*.mp. or exp Clinical Laboratory Techniques/

    14. Electrophysiology/ or electrophysiology.mp.

    15. 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14

    16. 4 and 15

    17. neuropathic pain.mp. or exp Neuralgia/

    18. radicular.mp. or exp Radiculopathy/ or exp Intervertebral Disc Displacement/

    19. exp Spinal Nerve Roots/ or nerve root*.mp.

    20. radicular pain.mp.

    21. 17 or 18 or 19 or 20

    22. 16 and 21

    23. low back pain.mp. or exp Back Pain/ or exp Low Back Pain/

    24. exp Sciatica/ or low back related leg pain.mp.

    25. LBP.mp.

    26. LBLP.mp.

    27. 23 or 24 or 35 or 26

    28. 22 and 27

    Searching other resources

    A manual search of key journals, conducted to compliment the search strategy, will include: ‘Spine, The Clinical Journal of Pain, PAIN, European Journal of Pain, The Journal of Pain and Musculoskeletal Science and Practice. Reference lists of included studies and the Cochrane Back Review Group will be reviewed to identify additional eligible studies. Finally, grey literature will be reviewed, using key sources including British National Bibliography for report literature, OpenGrey and EThOS.

    Data collection and analysis

    Selection of studies

    The selection of relevant articles will commence with independent screening by the two review authors (JM and BB). Initially, titles and abstracts will be screened against the eligibility criteria. Studies will be categorised into included, excluded (clearly irrelevant) and unsure groups.19 Full texts will be retrieved for studies that may meet the eligibility criteria and independently reviewed by the two review authors. Included studies must be agreed by both review authors, and any unresolved disagreements will be brought to a third author for decision (ABR). Agreement between review authors will be analysed using the kappa statistic at title/abstract screening stage and full-text screening stage.20

    Data extraction and management

    Data will be extracted independently by the two reviewers. A customised data extraction form, piloted and employed in our previous systematic review,15 will be used. The third reviewer (ABR) will mediate any disagreement in data extraction between the two review authors. Data items to be extracted from the included studies are summarised in table 1. If data items are not available, study authors will be contacted via email.21 An initial email will be sent to study authors to request for missing information if no response is received after 2 weeks a second reminder email will be sent.21 Covidence (Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia, www.covidence.org) will be used to manage citations, identify and remove duplicates and to store abstracts and full texts.

    View this table:
    Table 1

    Summary of data items to be extracted

    Assessment of methodological quality

    Risk of bias in individual studies

    The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool will be applied independently (JM and BB) to assess risk of bias in the included studies. The QUADAS-2 tool was developed as a tool to assess risk of bias in diagnostic accuracy studies. The QUADAS-2 tool consists of four domains: patient selection, index test, reference standard and flow and timing.22 The tool assesses risk of bias (relating to bias within the study that distorts the primary diagnostic data) and applicability (relating to the extent to which the research study in question is applicable to the systematic review question). Each domain is assessed for risk of bias. Patient selection, index test, reference standard domains are assessed for applicability concerns. Both risk of bias and applicability concerns are used to construct an overall summary judgement of each study, either ‘at risk’ or ‘low risk’.22 Any disagreements between the two reviewers will be discussed initially, and if the disagreement persists it will be brought to the third reviewer for decision (ABR).

    Data synthesis

    Data synthesis will follow the same process as our previous review.15 Initially, heterogeneity will be explored in study designs, population, comparable diagnostic data and reference standard to inform the data synthesis approach. If pooling of data is not possible, which is likely based on initial scoping searches, then a narrative synthesis will be conducted.

    A narrative synthesis framework, specific to systematic reviews, will be adopted.23 The framework will be modified for the purpose of this study by removing the initial stage of synthesis pertaining to developing a theoretical model of how interventions work, as it is not relevant to diagnostic accuracy studies. The narrative synthesis will consist of the three remaining stages: developing a preliminary synthesis of findings of included studies, exploring relationships in the data and assessing the robustness of the synthesis.23

    Summary measures

    Primary diagnostic data (sensitivity, specificity, PVs and LRs) will be presented as summary measures. A formula will be used to calculate primary diagnostic data in cases where only raw data are available.24 Summary tables will describe primary diagnostic data in relation to the index test: level of accuracy, discriminatory properties and strength of agreement.

    Level of accuracy

    To date, there is no clear accepted taxonomy for characterising level of accuracy for sensitivity and specificity.25 Therefore, previous research has informed how levels of accuracy for sensitivity and specificity are described in this study; low (<50%), low/moderate (51%–64%), moderate (65%–74%), moderate/high (75%–84%) and high (>85%).15 26 27

    Discriminatory properties

    Positive and negative LRs (+LR and −LR) will be used in order to describe the discriminatory properties of the index test: conclusive (+LR >10 and −LR<0.1), strong (+LR 5–10 and −LR 0.1–0.2), weak (+LR 2–5 and −LR 0.2–0.5, negligible (+LR 1–2 and −LR 0.5–1).15 26 27

    Strength of agreement

    Landis and Koch developed a grading system using a kappa-type statistic to describe strength of agreement in reliability, which will be adopted in this review: 0: poor, 0–0.21: slight, 0.21–0.40: fair, 0.41–0.60: moderate, 0.61–0.80: substantial and 0.81–1.00: almost perfect.15 26 28

    Confidence in cumulative evidence

    Grading of Recommendations, Assessment, Development and Evaluations (GRADE) will be used to assess the level of evidence.29 GRADE has been adapted for it use in diagnostic accuracy research.29 The two reviewers will independently assess each study and assign a level of evidence (high, moderate, low or very low). Six factors will downgrade the level of evidence; study design (cross-sectional/longitudinal studies will not be analysed separately to case–control studies), risk of bias (informed by QUADAS-2), inconsistency of evidence, indirectness of evidence, imprecision of results and publication bias. Factors resulting in the level of evidence being upgraded include: dose effect, large estimates of accuracy and residual plausible confounding.29

    Ethics and dissemination

    Ethical approval is not required for this systematic review. Findings will add to the growing body of literature investigating the identification of neuropathic pain in LBLP. The findings of this review will be published in a peer-reviewed journal and presented at pertinent conferences. Finally, the results of this study will be shared with the Spinal Pain Patient Partner Advisor Group at Western University.

    Discussion

    Uncertainty among researchers and clinicians exists when selecting the best diagnostic investigation to identify neuropathic pain in LBLP. Imprecision in the identification of neuropathic pain in LBLP can lead to inappropriate and untimely intervention, and therefore, poses a great risk to patient care. This review aims to address the uncertainty by investigating the diagnostic utility of diagnostic investigations for LBLP. Knowledge of the most appropriate diagnostic investigation will help to inform a clinician’s decision-making when identifying neuropathic pain in LBLP, which will lead to precision management and thus better patient care. However, as identified from the scoping search, heterogeneity is likely in this body of evidence, and therefore, clinical recommendations may not be possible. Furthermore, due to the exclusion of non-English studies, generalisability of findings will be reduced. Case–control design studies have been included in this review in order to capture all relevant studies, however, this design is associated with a higher risk of bias. If recommendations are not possible based on this synthesis, further research recommendations will be made.

    Ethics statements

    Patient consent for publication

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    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Twitter @uwo_dwalton, @HeneghanNicola, @abrushton

    • Contributors JM is a PhD student, lead author and first reviewer, ABR is the lead supervisor, DMW, NRH and TN are co supervisors. BB is the second reviewer. ABR is the guarantor of the review. JM led on manuscript development. All the authors contributed to the final manuscript. Data collection will be conducted by JM, BB and ABR. Draft manuscripts will be reviewed by ABR, DMW, NRH and TN. All authors will contribute to the dissemination of the protocol.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.