Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt

Study Overview
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Brief Summary
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Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China

Detailed Description
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Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.

Official Title
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Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a Multi-center Cross-sectional Registry Study of Clinical Characteristics and Treatment Survey of PDN in China

Conditions
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Painful Diabetic Peripheral Neuropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older patients definite diagnosis of type I and type II diabetes evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion). the pain lasts for at least 3 months signed informed consent Exclusion Criteria: other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.) dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalnce of irrational use of pain reliever drugs | percent | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Douleur Neuropathique4 questions(DN4) | unit | baseline | 
| Visual Analogue Score(VAS) | 1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain. | baseline | 
| Patient Health Questionnaire(PHQ-9) | 0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression. | baseline | 
| Generalized Anxiety Disorder Screener (GAD-7) | 0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety. | baseline |