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IRCT20110413006186N13 IRCT 2019-05-27 Rasht University of Medical Sciences The effect of electric stimulation through skin and duloxetine on diabetic neuropathic pain A Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Duloxetine on Diabetic Peripheral Neuropathic pain 2019-06-22 anticipated 60 Complete https://irct.ir/trial/39653 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm.This study will be conducted as a pilot study in two groups of 30. The responsible physician for this study will randomly divide the patients into TENS (T) and Duloxetine (D) groups based on quadruple block method, Blinding description: Three months before starting the treatment, patients will be asked to discontinue all their analgesics and receive gabapentin 400-300 milligrams daily. After three months, if the symptoms of the patient are adequately controlled and there were no side effects, They will be excluded. Other patients who did not respond to the treatment will be randomly assigned to TENS (T) or Dolextine (D) by the responsible physician. In this study, the physician that evaluates patients after treatment is blind and unaware of the treatment group. But because of the method of administration, patients are aware of their treatment. 2-3 Diabetic Peripheral Neuropathy. Intervention 1: Intervention group: Three months before the start of treatment, patients will be asked to discontinue all their analgesics and receive gabapentin 400-300 milligrams per day. If the symptoms of the patient were not adequately controlled with this drug and Or have side effects they will be excluded. Three months later, patients will randomly be divided into two groups: TENS (T) and Duloxetine (D).In group T, an electrode above the wrist and another will be placed below the knee. Patients will receive a tense scan (E 3 model, Omran Location) for 20 minutes with a ((80 Hz, 50 Amp, 0.2 ms Square Pulse 2 to 3 times sensory threshold) profile. For four weeks, sessions will be held Every other day. Then, twice a week for three months, patients undergo treatment with Tense. In the first 4 weeks, patients will be visited weekly and then every 4 weeks. Patients will be followed up for 3 months. Intervention 2: Intervention group: In the duloxetine group (20 milligrams tablets, the Abidi Pharmaceutical Company), in the first week, 20 milligrams per day, in the second week, 40 milligrams per day , and from week 3 to 12 ,60 milligrams of duloxetine per day will be received. During the first 4 weeks,they will be visited weekly and then every 4 weeks.Patients will be follow up for 3 months. 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 not decided yet
public Dr Bahram Naderi Nabi
Poursina Hospital
Rasht Iran (Islamic Republic of) 4193713189 +98 13 1321 0434 naderi_bahram@yahoo.com Rasht University of Medical Sciences scientific Dr Bahram Naderi Nabi
Poursina Hospital
Rasht Iran (Islamic Republic of) 4193713189 +98 13 1321 0434 naderi_bahram@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patients type I or II diabetes mellitus, with diabetic neuropathic pain Resistant to usual drug treatments, at least for 6 months Minimum Pain Rating 4 based on Numerical Rating Having normal creatinine and CBC blood counts HBA1C less than 8%. 18 years no limit Both Having a pacemaker or defibrillator Having brain stimulators Infection or inflammation at the site of electrodes Other neuropathies with causes other than diabetes Alcohol consumption history Malignant history Tens Records history Pregnancy Bipolar patients Duloxetine contraindications such as liver or kidney failure and MAO-I simultaneous use E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified Treatment - Devices Treatment - Drugs Intervention group: Three months before the start of treatment, patients will be asked to discontinue all their analgesics and receive gabapentin 400-300 milligrams per day. If the symptoms of the patient were not adequately controlled with this drug and Or have side effects they will be excluded. Three months later, patients will randomly be divided into two groups: TENS (T) and Duloxetine (D).In group T, an electrode above the wrist and another will be placed below the knee. Patients will receive a tense scan (E 3 model, Omran Location) for 20 minutes with a ((80 Hz, 50 Amp, 0.2 ms Square Pulse 2 to 3 times sensory threshold) profile. For four weeks, sessions will be held Every other day. Then, twice a week for three months, patients undergo treatment with Tense. In the first 4 weeks, patients will be visited weekly and then every 4 weeks. Patients will be followed up for 3 months. Intervention group: In the duloxetine group (20 milligrams tablets, the Abidi Pharmaceutical Company), in the first week, 20 milligrams per day, in the second week, 40 milligrams per day , and from week 3 to 12 ,60 milligrams of duloxetine per day will be received. During the first 4 weeks,they will be visited weekly and then every 4 weeks.Patients will be follow up for 3 months. Pain caused by diabetic peripheral neuropathy. Timepoint: Before starting treatment, 1 month and 3 months after starting treatment. Method of measurement: Patients will be assessed based on NRS (Numerical Rating Scale). Rasht University of Medical Sciences Approved 2019-05-11 Ethics Committee Of Guilan University Of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)