Pain Diabetic Peripheral Neuropathy（DPN) in China

Diabetic Neuropathies Clinical Trial

Official title:

Clinical Characteristics and Treatment of Pain Diabetic Peripheral Neuropathy（DPN） in China: a Multi-center Cross-sectional Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456465
• Other study ID #: PUTH2018054
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	moderate and severe pain (VAS score =4)	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.	Time at recruitment
Secondary	Demographic data	A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders	Time at recruitment
Secondary	Clinical manifestations of pain: VAS score	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.	Time at recruitment
Secondary	Depression screening/assessment: PHQ-9 scale	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.	Time at recruitment
Secondary	Anxiety screening/assessment: GAD-7 scale	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.	Time at recruitment