Diabetes
Conditions
Interventions
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: A. Patients with confirmed diabetes mellitus, without and with pain symptoms (1:1) ; B. PDN patients, according to the Chinese Diabetes Association guidelines (2020 edition) , had clinically diagnosed diabetes and had had diabetic neuralgia for 3 months or more; mean pain vas 3 points; C. Age 30-60 years, with no restriction on sex; D. eligible for Magnetic Resonance Examination; E. Ability to make subjective judgements, to read and understand questionnaires, to answer and sign; F. Willingness to sign informed consent; G. Able to cooperate with clinical data collection and follow-up as required by the trial; H. Cognitive, auditory, and test-related responses and operations can be completed.
Exclusion criteria
Exclusion criteria: Exclusion criteria: a. Lower limb ulcers or amputations; b. Glycated hemoglobin HbA1c > 10%; c. Body mass index BMI > 45; d. Daily oral morphine equivalent > 120mg; e. Chronic pain related to other diseases; f. Progressive neuropathy, such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, meningitis, brain or spinal cord tumors, acute intervertebral disc protrusion, spinal canal stenosis, brachial plexus injury, etc.; g. Previous history of spinal surgery; h. Presence of implanted medical devices in the body; i. Primary or metastatic tumors; j. Pregnant or planning to become pregnant; k. Drug or alcohol dependence; l. Mental or psychological disorders that affect pain perception; m. Clinically diagnosed as ischemic pain caused by diabetic lower limb vascular ischemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of multi-modal magnetic resonance imaging of the spinal cord; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog Scale, VAS;SF-MPQ-2;Douleur Neuropathique, DN4;Modified neuropathy symptom score;Pain and Sleep Questionnaire;Neuroelectrophysiology;Quantitative Sensory Test, QST; | — |
Countries
China
Contacts
Public ContactYinhui Fan
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed