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IRCT20190129042540N1 IRCT 2019-03-12 Rafsanjan University of Medical Sciences botulinum toxin type A and diabetic neuropathy The effects of botulinum toxin type A injections on pain symptoms, quality of life and sleep quality of patients with diabetic neuropathy : A randomized double-blind clinical trial 2017-01-06 anticipated 50 Complete https://irct.ir/trial/37211 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization: To randomize individuals, two groups of random number table method was used. Therefore the direction of reading the numbers was chosen towards the right side. Even numbers were considered for the intervention group and odd numbers was considered for the placebo group, Blinding description: investigator and patients are blind in this study . Other collegues such as nurse and who inject Dysport and analyzer are not blinded. 2-3 Diabeticr polyneuropathy. 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 receive the normal saline as the same volume injected in each point according to the grid pattern. No - There is not a plan to make this available Justification or reason for not sharing IPD is We decided to present it in an article.
public Alireza Vakilian
No1,4th Alley, Imam Aven. Rafsanjan .
Rafsanjan Iran (Islamic Republic of) 7717653995 +98 34 3428 9393 alirezavakilian7@gmail.com Rafsanjan University of Medical Sciences scientific Alireza Vakilian
1,4th Alley,Imam Avenue,
Rafsanjan Iran (Islamic Republic of) 7717653995 +98 34 3428 9393 alirezavakilian7@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) 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 40 years 70 years Both 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 E10.42 Type 2 diabetes mellitus with diabetic polyneuropathy Treatment - Drugs Placebo 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 Control group:Patients receive the normal saline as the same volume injected in each point according to the grid pattern 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. Rafsanjan University of Medical Sciences Approved 2017-01-01 Ethics committee of Rafsanjan University of Medical Sciences Central Organization of Rafsanjan University of Medical Siences, Imam Ali Avenue. Rafsanjan . rafsanjan Kerman Iran (Islamic Republic of)