Clinical trial NCT04456465: Pain Diabetic Peripheral Neuropathy（DPN) in China
Official title: Clinical Characteristics and Treatment of Pain Diabetic Peripheral Neuropathy（DPN） in China: a Multi-center Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathies
Keywords: Pain diabetic peripheral neuropathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pain diabetic peripheral neuropathy（DPN） in China

Brief summary: To understand the clinical characteristics of DPN patients in China; To investigate the distribution of DPN patients with depression and anxiety symptoms; To investigate the related factors of moderate and severe pain in DPN patients; To investigate the treatment of pain and depression and/or anxiety in DPN patients.

Detailed description: Pain diabetic peripheral neuropathy (DPN) is a heavy global economic burden. An American observational study in 2013 showed that the total average annual adjusted direct medical cost/person for DPN patients was $4,841, and the total average annual adjusted indirect medical cost/person was $9,730. A retrospective study in the United States in 2015 showed that the total annual direct medical cost per person for diabetes was $6,632, DPN ($12,492), DPN ($27,931), and severe DPN ($30,755) were 4.6 times higher than those for patients with diabetes alone. According to the 2015 European survey, the total annual direct medical cost per person for DPN patients in the United Kingdom was €2,963 (£2,511), of which 40% was used for hospitalization.

At present, there are no studies on the population epidemiology, depression and drug use of DPN in China. This study mainly investigates the above problems.

Eligibility criteria: Inclusion Criteria:

* outpatients who are elder than 18 years old with history of type 1or type 2 diabetes
* The presence of symptoms, signs and/or electrophysiological evidence of diabetic peripheral neuropathy
* The patient presents spontaneous pain (continuous or intermittent acupuncture pain, electric shock pain, burning pain, etc.) or induced pain (sensory hypersensitivity, paresthesia, etc.)
* The pain lasts for at least 3 months
* Informed consent has been signed

Exclusion Criteria:

* Patients with other causes of neuropathic, non-neuropathic, or mixed pain: for example, cervical/lumbar degenerative diseases, arthritis, nerve root compression, paraneoplastic syndromes, cerebrovascular diseases, spinal diseases, other peripheral neuropathies (immunological, toxic, nutritional peripheral neuropathies, etc.)
* Dementia, substance abuse, etc., severely affect cognitive and communication skills

Primary outcomes:
measure: moderate and severe pain (VAS score ≥4)
timeFrame: Time at recruitment
Secondary outcomes:
measure: Demographic data
timeFrame: Time at recruitment
measure: Clinical manifestations of pain: VAS score
timeFrame: Time at recruitment
measure: Depression screening/assessment: PHQ-9 scale
timeFrame: Time at recruitment
measure: Anxiety screening/assessment: GAD-7 scale
timeFrame: Time at recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References: