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NCT Number: NCT04456465

Pain Diabetic Peripheral Neuropathy（DPN) in China

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain diabetic peripheral neuropathy

Other

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.

Primary outcomes

  1. moderate and severe pain (VAS score ≥4)

    Time frame: 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 outcomes

  1. Demographic data

    Time frame: 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

  2. Clinical manifestations of pain: VAS score

    Time frame: 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.

  3. Depression screening/assessment: PHQ-9 scale

    Time frame: 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.

  4. Anxiety screening/assessment: GAD-7 scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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