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NDS and NSS for Screening Diabetic Neuropathy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07557641
Enrollment
228
Registered
2026-04-29
Start date
2024-03-14
Completion date
2026-03-13
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Keywords

Diabetic Peripheral Neuropathy, Diabetic Sensorimotor Polyneuropathy, Neuropathy Disability Score, Neuropathy Symptom Score, Diabetes Mellitus, Diagnostic Accuracy, Screening, Nerve Conduction Study, Peripheral Neuropathy

Brief summary

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.

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.

Interventions

None listed

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of NDS and NSS for Diabetic NeuropathySingle visit (cross-sectional assessment)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).

Secondary

MeasureTime frameDescription
Prevalence of Diabetic Peripheral NeuropathySingle visitTo determine the prevalence of diabetic peripheral neuropathy based on nerve conduction study results.
Clinical Factors Associated With NeuropathySingle visitTo assess associations between clinical variables (e.g., duration of diabetes, glycemic control) and neuropathy.

Countries

Thailand

Contacts

STUDY_DIRECTORJakkrit Amornvit, MD

King Chulalongkorn Memorial Hospital

PRINCIPAL_INVESTIGATORTharadon Deepracha, MSc

Chulaneuroscience Center, King Chulalongkorn Memorial hospital, The Thai Red Cross Society

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026