Diabetic neuropathy
Conditions
Interventions
Duloxetin 60mg daily p.o.
Sponsors
Chiba university, Graduate school of medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed of type II diabetes 2) Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness). 3) Possible to exclude other diagnoses which cause neuropathic pain. 4) More than 1 month duration of symptom. 5) Patients who meets more than 2 of 3 below: i) neuropathic symptom of lower extremities (L/Es) ii) Decreased sensation of distal part of L/Es. iii) Decreased or absent tendon reflexes of L/Es. 6) Patients who meets more than 1 of 2 below: i) Disturbance of ADL due to neuropathic pain ii) More than 4 in the BPI 24h average pain score. 7) Age 20-80 8) Documented consent by the patient or substitutes
Exclusion criteria
Exclusion criteria: 1) Patients taking duloxetine, pregabalin, carbamazepine, mexiletine, opioid, tramadol within 2 weeks before the registration. 2) Patients taking MAO inhibitors within 2 weeks prior to the registration. 3) Patients taking medications which have large effect to the cerebral blood flow. 4) Major blood sugar decrease within 4 weeks before registration. 5) Patients likely to experience major improvement of their blood sugar control. 6) History of drug abuse or addiction. 7) Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.) 8) Pregnancy or desire to bear children. 9) Allergic history to duloxetine 10) History of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within 1 year prior to the registration. 11) MMSE less than 23. 12) Patients considered inappropriate by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral blood flow measured by single photon emission computed tomography (whole brain analysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cerebral blood flow measured by single photon emission computed tomography (region of interest analysis). 2) pain related somatosensory evoked potentials findings (amplitude, latencies, threshold, reaction time) 3) BPI(Brief pain inventory) 24h average pain severity score. 4) BPI ADL score. 5) SFMPQ 6) PHQ-9 | — |
Countries
Japan
Contacts
Public ContactKeisuke Watanabe
Chiba university, Graduate school of medicine. Department of neurology
Outcome results
None listed