Pain Diabetic Peripheral Neuropathy（DPN) in China

Completed

• Conditions: Diabetic Neuropathies

• Registration Number: NCT04456465
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
moderate and severe pain (VAS score ≥4)	Time at recruitment	The correlation factors of moderate and severe pain (VAS score ≥4) were analyzed exploratively. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Clinical manifestations of pain: VAS score	Time at recruitment	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. A higher score indicates greater pain intensity.
Demographic data	Time at recruitment	A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders
Depression screening/assessment: PHQ-9 scale	Time at recruitment	The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Scores each of the criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score.
Anxiety screening/assessment: GAD-7 scale	Time at recruitment	Generalized Anxiety Disorder 7-Item Scale (GAD-7): This symptom assessment tool measures seven anxiety symptoms on 4-point scales. Average time to complete: 3 minutes. Interpretation: Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China