Background
Objective
Methods
Design
Eligibility criteria
Inclusion criteria
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Patient History items (e.g. aggravating factors, pain location, pain description)
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Clinical examination items (e.g. neurodynamic testing, neurological examination, range of movement)
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Screening tools (e.g. LANSS, StEP)
Exclusion criteria
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Not written in English
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Studies that did not compare an index test (patient history and/or clinical examination and/or screening tools) against a reference standard to identify NP in LBLP [20]
Information sources
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Electronic databases: CINAHL, EMBASE, MEDLINE, Web of Science, Cochrane Library, AMED, Pedro and PubMed
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Key journals: Musculoskeletal Science and Practice, PAIN, European Journal of Pain, The Journal of Pain and The Clinical Journal of Pain
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Grey literature: British National bibliography, OpenGrey and EThOS
Search strategy
Study records
Data management
Selection process
Data collection and data items
Risk of bias
Summary measures
Data synthesis
Confidence in cumulative evidence
Factors that determine and can decrease the quality of evidence | Explanations and how the factor may differ from the quality of evidence for other interventions |
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Study design | Cross-sectional or cohort studies in patients with diagnostic uncertainty and direct comparison of test results with an appropriate reference standard (best possible alternative test strategy) are considered high quality and can move to moderate, low or very low depending on other factors. |
Risk of bias (limitations in study design and execution) | Representativeness of the population that was intended to be sampled. Patient selection: consecutive or random sample of patients enrolled? Case-control design avoided? Did the study avoid inappropriate exclusions? Independent comparison with the reference standard. All enrolled patients should receive the index test and the reference standard test. Diagnostic uncertainty should be given. Is the reference standard likely to correctly classify the target condition? Flow and timing: was there an appropriate interval between index test(s) and reference standard? |
Indirectness Patient population, diagnostic test, comparison test and indirect comparisons of tests | The quality of evidence can be lowered if there are important differences between the populations studied and those for whom the recommendation is intended (in prior testing, the spectrum of disease or co-morbidity); if there are important differences in the tests studied and the diagnostic expertise of those applying them in the studies compared to the settings for which the recommendations are intended; or if the tests being compared are each compared to a reference (gold) standard in different studies and not directly compared in the same studies. Panels assessing diagnostic tests often face an absence of direct evidence about impact on patient-important outcomes. They must make deductions from diagnostic test studies about the balance between the presumed influences on patient-important outcomes of any differences in true and false positives and true and false negatives in relationship to test complications and costs. Therefore, accuracy studies typically provide low quality evidence for making recommendations due to indirectness of the outcomes, similar to surrogate outcomes for treatments. |
Important Inconsistency in study results | For accuracy studies unexplained inconsistency in sensitivity, specificity or likelihood ratios (rather than relative risks or mean differences) can lower the quality of evidence. |
Imprecise evidence | For accuracy studies wide confidence intervals for estimates of test accuracy, or true and false positive and negative rates can lower the quality of evidence. |
High probability of Publication bias | A high risk of publication bias (e.g., evidence only from small studies supporting a new test, or asymmetry in a funnel plot) can lower the quality of evidence. |
Results
Study identification
Study characteristics
Author | Study design | Phenomena of interest | Inclusion & exclusion criteria | Population | Index test | Reference standard |
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Capra et al., 2011 [16] Italy | Cross-sectional observational study | Sciatica with or without lumbar pain | Inclusion: 16–85 years, acute or recurrent sciatica (located distal to the knee), undergone MRI. Exclusion: diabetes, neoplasia, spinal cord disease, workers compensation, prior surgery, peripheral neuropathy, retroperitoneal pathology. | *n = 2352 (Female: n = 1120, Male: n = 1232) Mean (*SD) age: 49.22 (14.68) | Straight leg raise | *MRI |
Gudala et al., 2017 [30] India | Cross-sectional observational study | *CLBP with or without leg pain | Inclusion: > 18, CLBP > 3 months, understand Hindi. Exclusion: diabetes, cancer, chronic pain conditions, pregnant, incomplete data. | n = 215 (Female: n = 104, Male: n = 111) Mean (SD) age: 46.6 (13.9) | *S-DN4, ID Pain, painDETECT questionnaire, *S-LANSS | Physician opinion |
Lin et al., 2017 [17] Taiwan | Cross-sectional observational study | Lumbar lateral stenosis involving L5 nerve root | Inclusion: back pain with or without leg pain lasting > 3 months, corresponding lesion on MRI (central spinal stenosis, lateral recess stenosis, foraminal stenosis, segmental instability. Exclusion: spinal tumour/infection, Cauda equina syndrome, refused index test, Visual analogue scale < 2, bilateral L5 symptoms. L4/5 foraminal stenosis or L5/S1 central stenosis and those who have pathology not involving the L4/5 or L5/S1 level. | n = 60 (Female: n = 38, Male: n = 22) Mean (SD) age: 61.37 (Nil reported) | *SQST | MRI: grade 3 lateral stenosis |
Poiraudeau et al., 2001 [31] France | Cross-sectional observational study | Sciatica associated with disc herniation | Inclusion: Patients hospitalised for acute or chronic sciatica of mechanical origin. Sciatica defined as: “lumbosacral and lower limb pain, associated or not with paraesthesias and with one of the following conditions: radicular pain below the knee after an L5 or S1 nerve root dermatome; and radicular pain above the knee associated with neurological impairment reflex abolition, muscular weakness or sensory defects in the corresponding radicular area).” (Poiraudeau et al., 2001). Exclusion criteria: LBP without sciatica, radicular pain in a dermatome other than L5 and or S1, systemic lumboradicular pain tumour, infectious or inflammatory disease, prior lumbar surgery, uncontrolled psychiatric disorder. | n = 78 (Female: n = 45, Male: n = 33) Mean (SD) age: 50 (16) | Bell’s test, *HE test, Lasegue signs, Crossed Lasegue sign | MRI, CT, saccoradiculography |
Scholz et al., 2009 [12] USA | Cross-sectional observational study | NP in LBP (radicular) | Inclusion: CLBP, pain duration ≥3 months, Visual analogue scale > 6, age ≥ 18 . Exclusion criteria: severe medical or psychiatric illness, painful disorder or neurological disease that might have interfered with the pain assessment, local infection | n = 138 (Female: n = 78, Male: n = 60) Mean (SD) age: 45 (Nil reported) | * StEP tool | Independent physician clinical diagnosis |
Smart et al., 2012 [18] Ireland | Cross-sectional observational study | Peripheral NP in patients with or without leg pain | Inclusion: > 18, LBP with or without leg pain, those with a dominance of peripheral NP (deemed through a Delphi consensus list). Exclusion: Patients with a history of diabetes or central nervous system injury, pregnancy or non-musculoskeletal LBP | n: 102 (Female: n = 53, Male: n = 49) Mean (SD) age: 44 (13.1) | Cluster of subjective/ objective indicators | Clinical judgement |
Trainor et al., 2011 [32] England | Cross-sectional observational study Pilot study | Upper/mid lumbar nerve root compression | Inclusion: lumbosacral radicular pain, defined as: pain radiating unilateral/bilateral distal to gluteal crease, pain distribution in dermatome area/1 or 2 levels above/below Exclusion: cervical/thoracic pain, Red flags, spinal pathology or systemic illness, recent quads injury or unable to lie in test position. | n: 16 (Female: n = 7, Male: n = 9) Mean (SD) age: 49 (Nil reported) | Slump knee bend | MRI |
Urban et al., 2015 [33] Canada | Cross-sectional observational study | NP in lower limb | Inclusion: LBP with or without leg pain, 25 years or >, English speaking, suitable for complete neuro exam, conservatively managed. Exclusion: Previous back surgery, systemic illness or central condition. | n: 21 (Female: n = n/a, Male: n = n/a) Mean (SD) age: Nil reported | Slump | Standard clinical Assessment |
Verwoerd et al., 2014 [34] Netherlands | Cross-sectional observational study | Lumbosacral nerve root compression | Inclusion: 18–65 age, diagnosed, by neurologist, “incapacitating lumbosacral radicular syndrome, 6–12 weeks. Exclusion: Cauda equina, unable to resist against gravity muscle strength, previous spinae surgery, sever comorbidity, pregnancy, similar episode in last 12 months. | n: 395 (Female: n = 147, Male: n = 248) Mean (SD) age: 42.8 (10) | History taking | MRI |
Vroomen et al., 2002 [19] Netherlands | Cross-sectional observational study | Lumbosacral nerve root compression | Inclusion: pain that warrants bed rest for 14 days, new onset LBLP (distal to gluteal crease). Exclusion: spinal surgery, pregnancy, severe comorbidity, contraindication to MRI. | n: 274 (Female: n = 139, Male: n = 135) Mean (SD) age: 46 (Nil reported) | History and Physical examination | MRI |
Walsh et al., 2009 [14] Ireland | Cross-sectional observational study | LBLP | Inclusion: unilateral LBLP, 18–70 age, speaks English. Exclusion: absence of unilateral LBLP, serious pathology, spinal surgery or neurological disease, unbale to tolerate testing positions. | n: 45 (Female: n = 23, Male n = 22) Mean (SD) age: 46 (11) | Nerve palpation | SLR + slump |
Study design
Participants
Index test
Reference standard
Risk of bias
Synthesis of results
Patient history data
GRADE Quality assessment | ||||||||||
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Index test/clinical indicators | Sample size | Studies per index test/clinical indicator | Phenomena of interest | Study design | RoB | Indirectness | Inconsistency | Imprecision | Publication bias | Quality |
395 | 1 | Lumbosacral nerve root compression | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,b | ||
Cluster of two symptoms and one sign: “pain referred in a dermatomal cutaneous distribution”, “History of nerve injury, pathology or mechanical compromise” and “Pain/symptom provocation with mechanical/movement test” | 464 | 1 | Peripheral NP in patients with or without leg pain | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,c | |
Model including: two patient characteristics (age and duration of disease), four symptoms from the history (paroxysmal pain, pain worse in leg than back, typical dermatomal distribution, worse on coughing/sneezing/straining) and two signs from the physical examination (finger to floor distance and Paresis). | 274 | 1 | Lumbosacral nerve root compression | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁⨁◯ MODERATE 3 | |
SLR | 2352 | 1 | Sciatica | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,c | |
SQST | 60 | 1 | Lumbar lateral stenosis involving L5 nerve root | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,c,d | |
Bell’s test, HE test, Lasegue signs, Crossed Lasegue signs | 78 | 1 | CLBP with or without leg pain | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,c,e | |
Slump knee bend | 16 | 1 | Upper/mid lumbar nerve root compression | Cross sectional observational design – pilot study | Serious indirectness | No serious inconsistency | Serious imprecision | Undetected | ⨁◯◯◯ VERY LOW 1,3,6,7,8 | |
Slump test | 21 | 1 | NP in Lower Limb | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁◯◯◯ VERY LOW 1,3,7 | |
Nerve palpation: 2 or more of sciatic, tibial, common peroneal | 45 | 1 | LBLP | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,i | |
S-DN4, ID pain, PDQ, S-LANNS | 215 | 1 | CLBP with or without leg pain | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁◯◯ LOW a,j | |
StEP tool | 138 | 1 | NP in LBP (radicular) | Cross sectional observational – no limitations in study design | Serious indirectness | No serious inconsistency | No serious imprecision | Undetected | ⨁⨁⨁◯ MODERATE 1,3,11 |
Patient history data and clinical examination data
Screening tool data
Discussion
Patient history and clinical examination
Screening tools
Collective synthesis of patient history data, clinical examination data and screening tool data
Strengths and limitations
Capra et al., 2011 [16] | Risk of bias Flow and timing (high risk): high risk due to the time intervals between the reference standard, index test and any other treatment administered was not stated in the study. Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Gudala et al., 2017 [30] | Risk of bias Index test (Unclear): it was not stated if the index test was administered without prior knowledge of reference standard results. Furthermore, the use of Physicians assessment as a gold standard was not supported with any pre-defined threshold. Reference standard (Unclear): it was not stated in the study whether the reference standard was administered without prior knowledge of the index test results. Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Lin et al., 2017 [17] | Applicability concerns Patient selection (high risk): The patient population selected for this study were exclusively surgical patients and therefore not entirely consistent with the target population for this review. Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Poiraudeau et al., 2001 [31] | Risk of bias Reference standard (high risk): examiner 1 of 3 was involved with initial patient clerking/examination which may have influenced interpretation of reference standard results. Flow and timing (high risk): All tests were done on the same day however the time intervals between tests were not specified. Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Scholz et al., 2009 [12] | Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Smart et al., 2012 [18] | Risk of bias Index test (high risk): index test was conducted with knowledge of the results of the reference standard. Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Trainor et al., 2011 [32] | Risk of bias Patient selection (high risk): convenience sampling was used to recruit patients. Flow and timing (high risk): ‘small’ intervals were taken between each examiner conducting the index test (slump knee bend test), which have influenced test result. Applicability concerns Patient selection: due to small sample size in this study the applicability to the wider target population is poor. Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Urban et al., 2015 [33] | Risk of bias Patient selection (high risk): convenience sampling was used to recruit patients. Flow and timing (high risk): the index test was completed immediately after the clinical examination (reference standard) which may have influenced the results of the index test. Applicability concerns Patient selection: due to small sample size in this study the applicability to the wider target population is poor. Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Verwoerd et al., 2014 [34] | Risk of bias Patient selection (Unclear): unclear how the patient population was recruited. Index test (Unclear): It was not specified if the index test was completed without knowledge of the reference standard results. Applicability concerns Patient selection (high risk): the patient population consisted of those with “severe sciatica” and therefore not representative of those with mild and moderate symptoms. Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Vroomen et al., 2002 [19] | Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |
Walsh et al., 2009 [14] | Risk of bias Reference standard (high risk): The reference standard was a neurodynamic test which has been found to have low diagnostic validity. Flow and timing (high risk): the SLR and slump test were performed immediately after the nerve palpation which may have affected the test findings. Applicability concerns Reference standard (Unclear): unclear as there is no clear gold standard for diagnosing NP in LBLP |