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IRCT20200827048547N1 IRCT 2020-09-14 Ahvaz University of Medical Sciences Evaluation of High tone and Duloxetine on diabetic neuropathy Comparing the efficacy of Duloxetine with High tone diabetic peripheral neuropathic pain 2019-08-28 anticipated 30 Complete https://irct.ir/trial/50639 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software, Blinding description: This study is a double blind study; In this study, the subject and the researcher are both unaware of the type of treatment used for the patient. Medications are delivered in uniform packages with a code specified by a third party and the information on the number of medications used by the therapist will not be visible. For the high tone procedure, it was performed on the patient by a third party. 3 Diabetic neuropathy. Intervention 1: Intervention group: Group A In the high tone treatment group, it was done three times a week. In this method, therapeutic electrodes were implanted in the femoral muscles and 230V muscle stimulation was performed with a stimulation duration of 4 seconds, which is about 10 minutes per day, the number of sessions is about 10 sessions. And the patient's examinations and the amount of pain reduction of the patient are done weekly and are recorded in the relevant table and chart. Intervention 2: Intervention group: Group B In the treatment with Duloxetine (Abidi Company), treatment with this drug is done once a day and weekly monitoring of patients with examinations and evaluation of pain relief and in case of non-response to drug treatment to 30 mg twice,. Increased per day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mehrnoosh Zakerkish
Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3001 zohre.ghafury@gmail.com Ahvaz University of Medical Sciences scientific Mehrnoosh Zakerkish
Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3001 zohre.ghafury@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Type 1 and 2 diabetes 24-hour mean pain score based on VAS pain visual scale> 4mm 18 years no limit Both Mood Disorder Disseminated anxiety disorder Avoid substance use A history of less than a year or more than 15 years of diabetes Receive medication to control diabetic polyneuropathy within 2 weeks before starting the study Existence of neuropathy due to another Peripheral vascular disease Pregnant or lactating women History of epilepsy Uncontrolled acute angle-closure glaucoma GFR less than 32 mmol / min Liver disease Heart disease E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Group A In the high tone treatment group, it was done three times a week. In this method, therapeutic electrodes were implanted in the femoral muscles and 230V muscle stimulation was performed with a stimulation duration of 4 seconds, which is about 10 minutes per day, the number of sessions is about 10 sessions. And the patient's examinations and the amount of pain reduction of the patient are done weekly and are recorded in the relevant table and chart. Intervention group: Group B In the treatment with Duloxetine (Abidi Company), treatment with this drug is done once a day and weekly monitoring of patients with examinations and evaluation of pain relief and in case of non-response to drug treatment to 30 mg twice,. Increased per day. Painful vision scale. Timepoint: During the study and on a weekly basis. Method of measurement: VAS scale. Ahvaz University of Medical Sciences Approved 2020-01-18 thics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS) Khuzestan Province, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)