Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt

NCT03520608 | Unknown

• 1 other identifier: 2018182
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Painful Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• prevalnce of irrational use of pain reliever drugs

  percent

  baseline

Secondary Outcomes (4)

• Douleur Neuropathique4 questions(DN4)

  baseline

• Visual Analogue Score(VAS)

  baseline

• Patient Health Questionnaire(PHQ-9)

  baseline

• Generalized Anxiety Disorder Screener (GAD-7)

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

approximately 1500 Chinese PDN outpatient patients were required

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dongsheng Fan

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

• Zhang Y, Zhang S, Pan L, Wang B, Sun Y, Gao L, Wang L, Cui L, Zhang Q, Shang H, Jin S, Qin X, Geng D, Yu X, Yang L, Li L, Li Z, Yan C, Sun H, Sun T, Du B, Cao J, Hu F, Ma J, Zhou S, Zhao F, Li W, Zheng J, Yi Y, Xu J, Hu B, Sheng B, Li Z, Zhao Z, Yang T, Wang N, Zhao H, Mima D, Qu H, Wang Y, Song F, Li X, Li N, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese Outpatients (PDNSCOPE): A Multicentre Cross-Sectional Registry Study of Clinical Characteristics and Treatment in Mainland China. Pain Ther. 2021 Dec;10(2):1355-1373. doi: 10.1007/s40122-021-00281-w. Epub 2021 Aug 7.

  PMID: 34363598 DERIVED

• Zhang Y, Li N, Zhao Y, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China. BMJ Open. 2019 Apr 8;9(4):e025722. doi: 10.1136/bmjopen-2018-025722.

  PMID: 30962233 DERIVED

Study Officials

• Dongsheng Fan

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan

CONTACT

+8601082265024; dsfan@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Peking University Third Hospital, Neurology Depatment

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-04

Locations

CN (1)