Diabetic sensorimotor polyneuropathy is a common complication of diabetes mellitus that can lead to pain, sensory loss, foot ulcers, and disability. Early detection is important, but standard diagnostic tests such as nerve conduction studies are not always easily accessible in routine clinical practice. This study aims to evaluate the accuracy and reliability of two simple clinical tools, the Neuropathy Disability Score (NDS) and the Neuropathy Symptom Score (NSS), for screening diabetic peripheral neuropathy. These tools are based on patient-reported symptoms and bedside neurological examination and may provide a practical alternative for early detection. In this cross-sectional diagnostic accuracy study, adult patients with diabetes will be recruited from King Chulalongkorn Memorial Hospital. Participants will undergo clinical assessments, questionnaires, laboratory investigations, and neurophysiological testing, including nerve conduction studies, which will serve as the reference standard. The performance of NDS and NSS will be analyzed to determine their sensitivity, specificity, and overall diagnostic value. The results of this study may support the use of simple, accessible screening tools for early identification of diabetic neuropathy, potentially improving patient care and reducing complications.
This study is an analytic cross-sectional diagnostic accuracy study designed to evaluate the performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) in screening for diabetic sensorimotor polyneuropathy. Adult patients with diabetes mellitus (type 1 and type 2) will be recruited from King Chulalongkorn Memorial Hospital. Eligible participants will undergo a standardized assessment protocol, including demographic and clinical data collection, physical examination, and laboratory investigations. Patient-reported outcomes will be assessed using validated questionnaires, including the Neuropathy Symptom Score (NSS), Neuropathy Disability Score (NDS), DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI), and other relevant clinical tools. All participants will undergo nerve conduction studies (NCS), which will serve as the reference standard for the diagnosis of diabetic peripheral neuropathy. Additional assessments may include quantitative sensory testing (QST), monofilament testing, hand grip strength measurement, ankle-brachial index (ABI), and body composition analysis, depending on clinical indication. The primary objective is to determine the diagnostic accuracy of NDS and NSS compared with the reference standard, including sensitivity, specificity, and optimal cutoff values. Secondary objectives include evaluating the prevalence of neuropathy among patients with diabetes, identifying associated risk factors, and comparing clinical characteristics between type 1 and type 2 diabetes. Statistical analysis will include descriptive statistics, group comparisons using appropriate parametric or non-parametric tests, and receiver operating characteristic (ROC) curve analysis to determine diagnostic performance. Correlation analyses will also be performed to assess associations between clinical variables and neuropathy outcomes. The findings from this study are expected to support the use of simple, cost-effective screening tools for early detection of diabetic peripheral neuropathy in clinical practice, particularly in resource-limited settings.
Study Type
OBSERVATIONAL
Enrollment
228
Chulaneuroscience Center, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society
Bangkok, Thailand
Diagnostic Accuracy of NDS and NSS for Diabetic Neuropathy
To evaluate the diagnostic performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) compared with nerve conduction studies (NCS) as the reference standard, including sensitivity, specificity, and area under the ROC curve (AUC).
Time frame: Single visit (cross-sectional assessment)
Prevalence of Diabetic Peripheral Neuropathy
To determine the prevalence of diabetic peripheral neuropathy based on nerve conduction study results.
Time frame: Single visit
Clinical Factors Associated With Neuropathy
To assess associations between clinical variables (e.g., duration of diabetes, glycemic control) and neuropathy.
Time frame: Single visit
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