Clinical trial NCT03520608: Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Painful Diabetic Peripheral Neuropathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: approximately 1500 Chinese PDN outpatient patients were required

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalnce of irrational use of pain reliever drugs
timeFrame: baseline
Secondary outcomes:
measure: Douleur Neuropathique4 questions(DN4)
timeFrame: baseline
measure: Visual Analogue Score(VAS)
timeFrame: baseline
measure: Patient Health Questionnaire(PHQ-9)
timeFrame: baseline
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongsheng Fan
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Zhang S, Pan L, Wang B, Sun Y, Gao L, Wang L, Cui L, Zhang Q, Shang H, Jin S, Qin X, Geng D, Yu X, Yang L, Li L, Li Z, Yan C, Sun H, Sun T, Du B, Cao J, Hu F, Ma J, Zhou S, Zhao F, Li W, Zheng J, Yi Y, Xu J, Hu B, Sheng B, Li Z, Zhao Z, Yang T, Wang N, Zhao H, Mima D, Qu H, Wang Y, Song F, Li X, Li N, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese Outpatients (PDNSCOPE): A Multicentre Cross-Sectional Registry Study of Clinical Characteristics and Treatment in Mainland China. Pain Ther. 2021 Dec;10(2):1355-1373. doi: 10.1007/s40122-021-00281-w. Epub 2021 Aug 7.
citation: Zhang Y, Li N, Zhao Y, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China. BMJ Open. 2019 Apr 8;9(4):e025722. doi: 10.1136/bmjopen-2018-025722.