NDS and NSS for Screening Diabetic Neuropathy

Utilizing the Neuropathy Disability Score and Neuropathy Symptom Score for Screening Diabetic Sensorimotor Polyneuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathic Pain (DPN)

Detailed Description

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 (Actual): 228

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Chulaneuroscience Center, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diabetes mellitus (type 1 and type 2) receiving care at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Participants will be recruited from neurology and endocrinology clinics and are representative of patients undergoing evaluation for diabetic peripheral neuropathy in a tertiary care setting.

Description

Inclusion Criteria:

• Adults aged 30 to 65 years
• Diagnosed with diabetes mellitus (type 1 or type 2) by a physician
• Able and willing to provide informed consent
• Willing to undergo clinical evaluation and neurophysiological testing, including nerve conduction studies

Exclusion Criteria:

• History of other causes of peripheral neuropathy (e.g., nutritional deficiency, alcohol-related neuropathy, chronic kidney disease)
• Known neuromuscular or neurological disorders (e.g., myopathy, hereditary neuropathy, Guillain-Barré syndrome, chronic inflammatory neuropathy)
• Exposure to neurotoxic agents (e.g., drugs, heavy metals)
• Presence of lower limb conditions interfering with assessment (e.g., amputation, chronic wounds, significant edema)
• Inability to communicate or complete study procedures

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Single visit (cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Diabetic Peripheral Neuropathy	To determine the prevalence of diabetic peripheral neuropathy based on nerve conduction study results.	Single visit
Clinical Factors Associated With Neuropathy	To assess associations between clinical variables (e.g., duration of diabetes, glycemic control) and neuropathy.	Single visit

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Director: Jakkrit Amornvit, MD, King Chulalongkorn Memorial Hospital; Principal Investigator: Tharadon Deepracha, MSc, Chulaneuroscience Center, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society

Publications and helpful links

General Publications

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
• Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
• Perkins BA, Orszag A, Ngo M, Ng E, New P, Bril V. Prediction of incident diabetic neuropathy using the monofilament examination: a 4-year prospective study. Diabetes Care. 2010 Jul;33(7):1549-54. doi: 10.2337/dc09-1835. Epub 2010 Mar 31.
• Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton LJ 3rd, Service FJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993 Apr;43(4):817-24. doi: 10.1212/wnl.43.4.817.
• Shewasinad Yehualashet S, Asefa KK, Mekonnen AG, Gemeda BN, Shiferaw WS, Aynalem YA, Bilchut AH, Derseh BT, Mekuria AD, Mekonnen WN, Meseret WA, Tegegnework SS, Abosetegn AE. Predictors of adherence to COVID-19 prevention measure among communities in North Shoa Zone, Ethiopia based on health belief model: A cross-sectional study. PLoS One. 2021 Jan 22;16(1):e0246006. doi: 10.1371/journal.pone.0246006. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Screening; Diagnostic Accuracy; Peripheral Neuropathy; Diabetic Peripheral Neuropathy; Nerve Conduction Study; Diabetic Sensorimotor Polyneuropathy; Neuropathy Disability Score; Neuropathy Symptom Score
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Peripheral Nervous System Diseases
• Other Study ID Numbers: COA No. 0318/2025; 214605 (Other Grant/Funding Number: Thai Red Cross Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request, subject to approval by the principal investigator, institutional review board/ethics committee requirements, and a data use agreement to protect participant confidentiality.
• IPD Sharing Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents will be provided to qualified researchers who submit a methodologically sound proposal for analyses consistent with the study objectives and approved by the principal investigator and relevant institutional and ethics requirements. The materials available will include the de-identified participant-level dataset underlying the published results, together with the study protocol, statistical analysis plan, and data dictionary, where applicable. Requests should be submitted in writing to the principal investigator, and access will be granted after review and execution of a data use agreement through a secure data-sharing mechanism.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No