Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (SCOPE)
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| ClinicalTrials.gov Identifier: NCT03520608 |
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Recruitment Status : Unknown
Verified April 2018 by Fan Dongsheng, Peking University Third Hospital.
Recruitment status was: Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
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Sponsor:
Peking University Third Hospital
Information provided by (Responsible Party):
Fan Dongsheng, Peking University Third Hospital
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Brief Summary:
Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China
| Condition or disease |
|---|
| Painful Diabetic Peripheral Neuropathy |
Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.
| Study Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a Multi-center Cross-sectional Registry Study of Clinical Characteristics and Treatment Survey of PDN in China |
| Estimated Study Start Date : | May 1, 2018 |
| Estimated Primary Completion Date : | November 1, 2018 |
| Estimated Study Completion Date : | May 1, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Peripheral Nerve Disorders
Primary Outcome Measures :
- prevalnce of irrational use of pain reliever drugs [ Time Frame: baseline ]percent
Secondary Outcome Measures :
- Douleur Neuropathique4 questions(DN4) [ Time Frame: baseline ]unit
- Visual Analogue Score(VAS) [ Time Frame: baseline ]1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain.
- Patient Health Questionnaire(PHQ-9) [ Time Frame: baseline ]0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression.
- Generalized Anxiety Disorder Screener (GAD-7) [ Time Frame: baseline ]0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
approximately 1500 Chinese PDN outpatient patients were required
Criteria
Inclusion Criteria:
- 18 years of age or older patients
- definite diagnosis of type I and type II diabetes
- evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy
- complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion).
- the pain lasts for at least 3 months
- signed informed consent
Exclusion Criteria:
- other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.)
- dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520608
Contacts
| Contact: Dongsheng Fan | +8601082265024 | dsfan@sina.com |
Locations
| China, Beijing | |
| Dongsheng Fan | Recruiting |
| Beijing, Beijing, China, 100191 | |
| Contact: Dongsheng Fan, MD +861082265694 dsfan@sina.com | |
Sponsors and Collaborators
Peking University Third Hospital
Investigators
| Principal Investigator: | Dongsheng Fan | Peking University Third Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fan Dongsheng, Director, Peking University Third Hospital, Neurology Depatment, Peking University Third Hospital |
| ClinicalTrials.gov Identifier: | NCT03520608 |
| Other Study ID Numbers: |
2018182 |
| First Posted: | May 11, 2018 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Diabetic Neuropathies Pain Neuromuscular Diseases Nervous System Diseases |
Neurologic Manifestations Diabetes Complications Diabetes Mellitus Endocrine System Diseases |