- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04456465
Pain Diabetic Peripheral Neuropathy(DPN) in China
Clinical Characteristics and Treatment of Pain Diabetic Peripheral Neuropathy(DPN) in China: a Multi-center Cross-sectional Survey
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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moderate and severe pain (VAS score ≥4)
Time Frame: Time at recruitment
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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.
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Time at recruitment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic data
Time Frame: Time at recruitment
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A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders
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Time at recruitment
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Clinical manifestations of pain: VAS score
Time Frame: Time at recruitment
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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.
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Time at recruitment
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Depression screening/assessment: PHQ-9 scale
Time Frame: Time at recruitment
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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.
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Time at recruitment
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Anxiety screening/assessment: GAD-7 scale
Time Frame: Time at recruitment
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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.
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Time at recruitment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUTH2018054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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