Pain Diabetic Peripheral Neuropathy（DPN) in China

NCT ID: NCT04456465

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-10-01

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.

Conditions

Diabetic Neuropathies

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Pain diabetic peripheral neuropathy

Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongsheng Fan, MD.PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

PUTH2018054

Identifier Type: -

Identifier Source: org_study_id