Painful Diabetic Peripheral Neuropathy
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older patients 2. definite diagnosis of type I and type II diabetes 3. evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy 4. complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion). 5. the pain lasts for at least 3 months 6. signed informed consent
Exclusion criteria
1. 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.) 2. dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalnce of irrational use of pain reliever drugs | baseline | percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Douleur Neuropathique4 questions(DN4) | baseline | unit |
| Visual Analogue Score(VAS) | baseline | 1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain. |
| Patient Health Questionnaire(PHQ-9) | baseline | 0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression. |
| Generalized Anxiety Disorder Screener (GAD-7) | baseline | 0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety. |
Countries
China
Contacts
Primary ContactDongsheng Fan
Outcome results
None listed