Diabeticr polyneuropathy. Type 2 diabetes mellitus with diabetic polyneuropathy
Conditions
Interventions
Intervention 1: intervention group: Patients receive the Toxin Botulinum A at the 8 units out of 12 points injected in each site according to the grid pattern. Intervention 2: Control group:Patients
Sponsors
Rafsanjan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Having type 2 diabetes for at least 3 years 40-70 years old providing a positive response to four or more questions in DN4 test evidence of diabetic neuropathy in lower limb electrophysiological examination
Exclusion criteria
Exclusion criteria: who were allergic to BTX-A using other drugs to reduce neuropathic pain a history of myasthenia gravis subjects with distal muscle weakness kidney dysfunction history of alcohol use post-operative patients who initiated taking medication after the onset of the study who used aminoglycosides peripheral vascular obstructive disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of pain. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Pain Visual Analogue Scale.;Quality of life. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Short Form-36Quality-of-Life Questionnaire.;Severity and quality of pain. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Neuropathic Pain Scale.;Sleep quality. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Vakilian
Rafsanjan University of Medical Sciences
Outcome results
None listed