Accuracy of Physical Exam for Chronic Lumbar Radiculopathy
Accuracy of Physical Exam for Chronic Lumbar Radiculopathy
This study included patients with symptoms suggesting lumbar radiculopathy. Patients were recruited by screening and referral from general practitioners, and those with large disc herniation obviously requiring surgery were excluded. The sample emerging from these criteria is typical for the chronic radiculopathy population seen in specialised care. Results from the study are relevant for our understanding of diagnostic accuracy in the common clinical setting where specialists have access to imaging findings prior to the clinical examination, and often are challenged by having to evaluate which of numerous positive imaging findings are to be considered clinically relevant.
The main finding is that individual clinical index tests lack diagnostic accuracy for predicting whether a lumbar nerve root is impinged or not at a specific level in patients with chronic lumbar radiculopathy in specialised care. The overall clinical evaluation, consisting of the specialists' combined interpretation of the patients' history and all index tests, was somewhat more accurate. For L5 and S1 nerve root impingement, however, LRs did not reach the levels usually considered necessary to influence post-test probability and thereby clinical decision-making (positive LR >5.0 and negative LR <0.2). Accuracy was better (positive LR 6.28, negative LR 0.70) for L4 nerve root impingement. This was probably because L4 nerve root involvement occurred only in 3 (2.6%) cases, and was suspected after the overall clinical evaluation only in 7 (6.0%) cases. This resulted in a high number of true negatives, and thereby high specificity. Clinically, the low pre-test probability for L4 nerve root involvement is well known, and these test properties are therefore not very useful. Accordingly, clinical examination is inaccurate both for predicting the presence or absence of nerve root impingement, and for clarifying the relevant level and side in patients with multiple positive imaging findings.
Our findings are mainly in accordance with other studies of selected populations from specialised care. Most previous studies have, however, aimed for a generalised understanding of test properties from such selected materials. This approach is confusing, as the pre-test probability always must be taken into consideration. Recently, a study aimed to specifically investigate the accuracy of clinical index tests from the neurological examination for identification of the level of disc herniation in patients with the target condition already confirmed by MRI. Unfortunately the study did not find evidence to support this. The results were disappointing, with no single test reaching an AUC >0.75, and only slightly better results (AUC = 0.80) for the neurologists' overall evaluation.
It has been a weakness of most previous studies that interpretation of the imaging findings has been limited to categorising the target condition (usually a disc herniation) as present or not, without considering whether a nerve root actually was impinged at the relevant spinal level and side. We therefore improved the study design by specifically addressing findings relevant for clinical decision-making: correspondence between index tests and impingement of specific nerve roots as revealed by MRI. Disappointingly, this did not improve diagnostic accuracy, neither for individual tests nor for the clinicians' overall evaluation. AUCs for L5 and S1 nerve root impingement did not reach levels above 0.66, which are even lower than those observed by Hancock et al. in an almost similar specialised care setting. This could be because we used one or more positive index tests as an inclusion criterion, which probably increased both the proportion of false positives and false negatives. The false negatives increased because the index tests are not independent of each other, implying that inclusion based on one or more positive tests entails an increased proportion of false negatives, since many tests are performed in each patient. We do not consider the selection of patients in our study a methodological weakness, but rather an expression of clinical reality in specialised care. There should, however, be concern about both the definition of the target condition and the reference standard being subjects to bias. First, neuroanatomical overlap between spinal segments influences accuracy when the analysis is done on the level of each single nerve root. Patients may have radiculopathy from causes other than ongoing nerve root impingement, and even when an impingement is present, this is not necessarily the cause of the pain. Imaging showed no sign of nerve root impingement in 56 (48.3%) of the included cases despite a clear history and clinical findings suggesting lumbar radiculopathy. This confirms that radiculopathy may have other causes, such as neuropathic and inflammatory conditions, or be mimicked by myofascial pain. Moreover, disc herniation without nerve root impingement was demonstrated in 25.9% of the included patients, and in 73.8% of those excluded due to symptoms classified as unspecific low back pain with referred leg pain. This is not surprising, since the prevalence of disc herniation revealed by MRI in the general population is known to be as high as 30%.
We suggest that our findings reflect clinical reality very well: in a population selected by referral from primary care and exclusion of the most obvious surgical cases, co-morbidity bias and imaging findings not related to the symptoms are common. Diagnostic imaging combined with clinical tests is therefore inaccurate for clarifying the cause of radicular pain. This is probably one of the reasons why these patients are so difficult to treat, and the same inaccuracy may cause significant inclusion bias in clinical trials evaluating treatments for lumbar radiculopathy.
The present study has weaknesses. We did not register inter-tester variability for the clinical tests and image interpretations. However, all clinicians were trained to perform the tests in a standardised manner, and agreement should thus be superior to that achieved between clinicians in daily practice. MRI was substituted with CT in 7 (6.0%) of the study subjects. A few cases of nerve root impingement may have been missed, but this is unlikely to have influenced the results significantly. Further, the duration of symptoms (average 42 weeks) was relatively long. Development of chronic centralised pain followed by regression of nerve root impingement may have occurred in some patients, and our results may not be generalisable to situations with shorter symptom duration.
Finally, it must be emphasised that the index tests work differently when applied in other settings. In unselected primary care populations, the proportion of false positives will be lower and the specificity of the tests higher. Accordingly, the tests may be useful in primary care to reduce the post-test likelihood of lumbar radiculopathy, and thereby restrict unnecessary referrals for imaging and specialised care. On the other hand, when applied in a highly selected surgical patient population with shorter duration of symptoms and a large disc herniation obviously corresponding with the symptoms, the proportion of true positives will be high and the proportion of false positives low, resulting in high sensitivity and specificity. The results from the present study should therefore not be generalised to unselected patient populations in primary care nor to even more selected surgical populations.
Discussion
This study included patients with symptoms suggesting lumbar radiculopathy. Patients were recruited by screening and referral from general practitioners, and those with large disc herniation obviously requiring surgery were excluded. The sample emerging from these criteria is typical for the chronic radiculopathy population seen in specialised care. Results from the study are relevant for our understanding of diagnostic accuracy in the common clinical setting where specialists have access to imaging findings prior to the clinical examination, and often are challenged by having to evaluate which of numerous positive imaging findings are to be considered clinically relevant.
The main finding is that individual clinical index tests lack diagnostic accuracy for predicting whether a lumbar nerve root is impinged or not at a specific level in patients with chronic lumbar radiculopathy in specialised care. The overall clinical evaluation, consisting of the specialists' combined interpretation of the patients' history and all index tests, was somewhat more accurate. For L5 and S1 nerve root impingement, however, LRs did not reach the levels usually considered necessary to influence post-test probability and thereby clinical decision-making (positive LR >5.0 and negative LR <0.2). Accuracy was better (positive LR 6.28, negative LR 0.70) for L4 nerve root impingement. This was probably because L4 nerve root involvement occurred only in 3 (2.6%) cases, and was suspected after the overall clinical evaluation only in 7 (6.0%) cases. This resulted in a high number of true negatives, and thereby high specificity. Clinically, the low pre-test probability for L4 nerve root involvement is well known, and these test properties are therefore not very useful. Accordingly, clinical examination is inaccurate both for predicting the presence or absence of nerve root impingement, and for clarifying the relevant level and side in patients with multiple positive imaging findings.
Our findings are mainly in accordance with other studies of selected populations from specialised care. Most previous studies have, however, aimed for a generalised understanding of test properties from such selected materials. This approach is confusing, as the pre-test probability always must be taken into consideration. Recently, a study aimed to specifically investigate the accuracy of clinical index tests from the neurological examination for identification of the level of disc herniation in patients with the target condition already confirmed by MRI. Unfortunately the study did not find evidence to support this. The results were disappointing, with no single test reaching an AUC >0.75, and only slightly better results (AUC = 0.80) for the neurologists' overall evaluation.
It has been a weakness of most previous studies that interpretation of the imaging findings has been limited to categorising the target condition (usually a disc herniation) as present or not, without considering whether a nerve root actually was impinged at the relevant spinal level and side. We therefore improved the study design by specifically addressing findings relevant for clinical decision-making: correspondence between index tests and impingement of specific nerve roots as revealed by MRI. Disappointingly, this did not improve diagnostic accuracy, neither for individual tests nor for the clinicians' overall evaluation. AUCs for L5 and S1 nerve root impingement did not reach levels above 0.66, which are even lower than those observed by Hancock et al. in an almost similar specialised care setting. This could be because we used one or more positive index tests as an inclusion criterion, which probably increased both the proportion of false positives and false negatives. The false negatives increased because the index tests are not independent of each other, implying that inclusion based on one or more positive tests entails an increased proportion of false negatives, since many tests are performed in each patient. We do not consider the selection of patients in our study a methodological weakness, but rather an expression of clinical reality in specialised care. There should, however, be concern about both the definition of the target condition and the reference standard being subjects to bias. First, neuroanatomical overlap between spinal segments influences accuracy when the analysis is done on the level of each single nerve root. Patients may have radiculopathy from causes other than ongoing nerve root impingement, and even when an impingement is present, this is not necessarily the cause of the pain. Imaging showed no sign of nerve root impingement in 56 (48.3%) of the included cases despite a clear history and clinical findings suggesting lumbar radiculopathy. This confirms that radiculopathy may have other causes, such as neuropathic and inflammatory conditions, or be mimicked by myofascial pain. Moreover, disc herniation without nerve root impingement was demonstrated in 25.9% of the included patients, and in 73.8% of those excluded due to symptoms classified as unspecific low back pain with referred leg pain. This is not surprising, since the prevalence of disc herniation revealed by MRI in the general population is known to be as high as 30%.
We suggest that our findings reflect clinical reality very well: in a population selected by referral from primary care and exclusion of the most obvious surgical cases, co-morbidity bias and imaging findings not related to the symptoms are common. Diagnostic imaging combined with clinical tests is therefore inaccurate for clarifying the cause of radicular pain. This is probably one of the reasons why these patients are so difficult to treat, and the same inaccuracy may cause significant inclusion bias in clinical trials evaluating treatments for lumbar radiculopathy.
The present study has weaknesses. We did not register inter-tester variability for the clinical tests and image interpretations. However, all clinicians were trained to perform the tests in a standardised manner, and agreement should thus be superior to that achieved between clinicians in daily practice. MRI was substituted with CT in 7 (6.0%) of the study subjects. A few cases of nerve root impingement may have been missed, but this is unlikely to have influenced the results significantly. Further, the duration of symptoms (average 42 weeks) was relatively long. Development of chronic centralised pain followed by regression of nerve root impingement may have occurred in some patients, and our results may not be generalisable to situations with shorter symptom duration.
Finally, it must be emphasised that the index tests work differently when applied in other settings. In unselected primary care populations, the proportion of false positives will be lower and the specificity of the tests higher. Accordingly, the tests may be useful in primary care to reduce the post-test likelihood of lumbar radiculopathy, and thereby restrict unnecessary referrals for imaging and specialised care. On the other hand, when applied in a highly selected surgical patient population with shorter duration of symptoms and a large disc herniation obviously corresponding with the symptoms, the proportion of true positives will be high and the proportion of false positives low, resulting in high sensitivity and specificity. The results from the present study should therefore not be generalised to unselected patient populations in primary care nor to even more selected surgical populations.
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