Therefore, inclusion criteria were Type-1 diabetes of five years or more or Type-2 diabetes of any duration with and without history of diagnosed DPN, confirmed by medical records. Participants were required to be fluent in English language to satisfy consent for the study. Exclusion criteria included active foot ulceration, visual evidence of recently healed foot ulceration, lower limb amputation of any kind or diagnosed peripheral neuropathy of an origin other than diabetes.
A four-site [ 27 ] and a ten-site monofilament [ 8 ] test were used. For the four-site test, site application was plantar surface of the hallux as well as first, third and fifth metatarsal heads, while the site test also included the plantar surface of the third and fifth digits, heel, medial arch, lateral arch and the dorsal surface of the mid foot. Perception of six or less sites in the site test [ 28 ] and three or less sites in the four-site test [ 8 ] were considered abnormal. The stylus of the device was applied to the apex of the right hallux and the amplitude of vibration of the device was then gradually increased until the participant could perceive the vibration.
The corresponding VPT value was immediately written on the assessment form and the process repeated until three values were recorded. For each tuning fork test a manually applied force to induce vibration was applied to the tines of the tuning fork before placing the device on the apex of the right hallux.
Participants were instructed to indicate verbally when they felt vibration and then when they perceived the vibration had stopped CHz. Once the vibration was perceived, the rater would randomly dampen the tuning fork CHz with their other hand and if the participant could not perceive that the vibration had stopped then this was considered an abnormal response dampening method [ 23 ]. Lastly, perception of less than four octals as quantified by the graduated tuning fork C64 Hz constituted an abnormal response [ 30 ].
In both the initial testing session and retest for all testing conducted as part of this study, raters performed the relevant neurological tests in a pre-determined random order on every participant in separate treatment rooms. Raters were blinded to the participant health status i.
The order of application of the tests was randomised using an online random number generator www. The order of raters was randomised in a manner that was not pre-determined and the order of site application of the monofilament was randomised at the discretion of the individual raters.
Participants were blind to all results, though were provided with a plain language summary on request at study completion. The tests were performed only on the right limb in order to satisfy the assumption of independence of data [ 31 ], with the right limb chosen rather than a random limb in order to minimise rater confusion. Participants were required to attend the retest after seven days at the same location and were required to close their eyes for each test procedure.
SPSS version 25 was used for statistical analysis. Results for all neurological tests were broken down into dichotomous variables, namely abnormal or normal results, with abnormal being indicative of neuropathy. Values below 0. Fifty participants volunteered for testing with monofilament and neurothesiometer, of whom 44 returned for the retest.
Six participants were unable to return within the required period of seven days and thus did not take part in the intra-rater reliability component of this study. Twenty-four participants volunteered for tuning fork testing, all of whom returned for the re-test.
Participant characteristics are detailed in Table 1. Inter-rater reliability: The graduated tuning fork k: 0. The results from our study indicate that monofilament, neurothesiometer and the tuning fork are acceptably reliable methods of testing protective sensation and vibration perception respectively, with some variability demonstrated between inter- and intra-tester reliability as well as with level of clinical experience.
Monofilament tests overall, appear to be reliable with clinical experience possibly increasing the reliability of the four-site test. Despite the acceptable levels of reliability demonstrated by these tests, caution must be used in relying on any one test in isolation.
Moderate reliability for example still indicates a marked margin of error in test interpretation and it is axiomatic that clinical tests that have the potential to change clinical practice and drive treatment strategies should strive for higher reliability.
When considering using these tests for diagnosis and monitoring of DPN we support the current recommendations of using more than one test e. In addition, we suggest that testing should be performed regularly and repetitively. Of note, our results relate specifically to the reliability of the tests used, i. While use of tests with high reliability is essential for effective clinical management, so too is the need for the tests to be able to diagnose the target condition.
A nine-site monofilament test has been shown to have excellent intra- and inter-reliability [ 20 ]. Meijer et al. The inter-rater reliability of four- and site tests from this present study demonstrated similar levels of reliability overall, although experience improved reliability for the four-site test. The excellent intra-rater reliability previously described in the nine-site monofilament test [ 20 ] was not replicated in the four or 10 site tests used in our study.
The large range of intra-rater reliability of the monofilament fair to substantial was not associated with greater clinical experience.
As these tests rely on subjective responses from a patient, it is possible that these tests will demonstrate variability regardless of the level of experience of the clinician. The reliability demonstrated may have been affected by the comparatively low participant numbers in the tuning fork cohort. Overall, the inter-rater reliability of vibration tests was substantial.
Our findings regarding the neurothesiometer are supported by two smaller studies investigating the neurothesiometer [ 22 ], biothesiometer and Maxivibrometer [ 25 ], respectively. While all tuning fork methods demonstrated substantial inter-rater reliability, the intra-rater reliability was moderate for all methods, and bordering on fair for the dampened method.
Previous investigation by Meijer et al. Perkins et al. Our findings of moderate intra-tester reliability of the graduated tuning fork are somewhat supported by Thivolet et al. A slightly smaller study previously reported low, non-significant inter-rater reliability of the graduated tuning fork [ 22 ], which contradicts our findings of substantial reliability.
However, the site application and methodology was too dissimilar to our present study to draw any meaningful comparisons. Whilst adding to the paucity of research investigating intra- and inter-rater reliability of vibration perception and monofilament testing in people with diabetes, findings of this study need to be considered in light of several limitations.
Though 50 participants attended for test and retest of monofilament and neurothesiometer, only 24 were involved in tuning fork testing. Our study is generalisable to people with type 2 diabetes only, however a strength of this study is that it included people with diagnosed DPN making it generalizable to people requiring testing and ongoing monitoring.
In addition, more extensive clinician training and clearer instruction to participants may improve reliability. Other neurological tests such as pain perception, proprioception, ankle reflexes, temperature perception, light touch perception and two-point discrimination were not investigated but may be reliable and of clinical value.
Neurological screening is routinely performed by health professionals on patients with diabetes as they are at risk of developing DPN. The results of this study also indicate there is a need for regular and repetitive testing and that a combination of tests should be used for screening and monitoring of DPN for Podiatrists regardless of experience level.
The reliability of alternate neurological screening methods warrants investigation. IDF diabetes atlas: global estimates of diabetes prevalence for and projections for Diabetes Res Clin Pract. CAS Google Scholar. Accuracy of monofilament testing to diagnose peripheral neuropathy: a systematic review. Ann Fam Med. Article Google Scholar. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population based cohort.
Prediction of incident diabetic neuropathy using the monofilament examination. Diabetes Care. A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. With p value less than 0. The results also show a statistically significant difference between diabetic patients and control by using Hz tuning fork, in which there is significant decrease in vibration sense in diabetic patients in comparison to control.
Denoting that tens is better than tuning fork in detecting vibration sense and early detection of diabetic peripheral neuropathy. Conclusion: DPN is very common in diabetic patients but it may take a long time to be diagnosed. This may lead to life threatening complications, like amputation. So it is critical to find new ways of diagnosing DPN early. Browse other volumes. Biosci Abstracts Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Searchable abstracts of presentations at key conferences in endocrinology. Endocrine Abstracts. Other examples of clinical studies which investigated the effect of clothing during physical examination do exist, including the auscultation of lung sounds through thin clothing [ 5 ] and measurement of blood pressure through sleeves using the auscultatory method [ 6 ].
These studies all resemble each other in that the focus of interest is sounds and vibrations and the spectrums in question are also similar. Kraman showed that lung sound perceived by stethoscope was somewhat deteriorated by one or two layers of indoor clothing but this effect can be reduced by force on the stethoscope head [ 5 ]. Liebl et al. An everyday experience was also found to be congruent with these results, that of a vibrating cell phone. All these data suggest that the interference from garments on vibration energy is little.
With regard to the vibration of a cell phone in vibration sensing, the use of a pager device in its vibration mode was reported to be used for clinical vibration testing in an era when cellular phones were not so common [ 4 ]. Therefore, the tuning fork was the instrument of choice in this study. Although one was available at the installation phase of the present study, it was discarded because the semiquantitative scale of this device seemed to provide insufficient time resolution for our requirements.
The physiology of Pacinian corpuscles may play a critical role in the sensation of vibration through clothing, due to their subcutaneous localization and wide field of perception [ 1 , 10 ].
The shorter vibration durations at the MM than at the GT are an unexpected finding for clinicians familiar with axonal polyneuropathies, due to the distal to proximal progression of degeneration. It has been concluded that substantial tissue damping affects the tuning fork while taking measurements at the MM. This is probably caused by the solid mass of the tibia which is substantially larger than that of the toe bones beneath the GT measurement points. We think that the shorter vibration durations at the MM can be attributed to this phenomenon, which has been analyzed in detail in the article by Goldberg and Lindblom [ 11 ].
This may be due to the fact that this study involved only mild to moderate cases of diabetic PNP and excluded the more advanced cases in whom vibration sensation was measured as totally absent distally.
It might be expected that, with more advanced disease, the GT measurement would have been able to exceed the MM in shortening of vibration sensation duration due to the distal axonopathy process.
In conclusion, this study shows that no practically significant difference arises from wearing socks when measuring vibration sensation with a tuning fork; any interference thus caused is negligibly small. This is true for the healthy population over a wide age range and also for patients within the clinical context of a diabetic polyneuropathy. However, this study does not aim to recommend measuring vibration sensation over socks. In the patients with chronic polyneuropathy, careful examination of the feet is crucial for the screening of ulcers and infections and leaving the socks in place during examination is strongly discouraged.
Besides, the socks would still have to be removed in order to perform the other modalities of neurological examination. Bearing these in mind, we hope that the results of the present study will be considered as a clinical clue indicating one of the remarkable properties of vibration sensation. The authors thank Dr. Meral et al. This is an open access article distributed under the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Article of the Year Award: Outstanding research contributions of , as selected by our Chief Editors. Read the winning articles. Meral , 1 Z. Matur , 2 B. Dertsiz , 1 and A. Academic Editor: C. Received 16 Jun Accepted 26 Jul Published 24 Oct Abstract Objective. Introduction The evaluation of vibration sensation informs the clinician about the integrity of mechanoreceptors in the skin, rapidly conducting large-diameter afferent fibers in the peripheral nerves and the dorsal column-medial lemniscus pathways in the central nervous system [ 1 , 2 ].
Methods 2. Subjects Fifty healthy volunteers H group; median age was 37 years, 22 male and 19 patients with diabetic polyneuropathy PNP group; median age was 57 years, 5 male were included in the study Table 1. Table 1. The duration of vibration sensation in the healthy volunteers and the patients with diabetic polyneuropathy.
Figure 1.
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