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IRCT20191210045685N1 IRCT 2020-07-04 Iran University of Medical Sciences Effectiveness of duloxetine in chronic low back pain Effetiveness of Duloxetine on severity of pain and quality of life in chronic low back pain in patients who had posterior spinal fixation (PSF) 2019-06-22 anticipated 50 Complete https://irct.ir/trial/48882 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple or unlimited randomization with coin throwing in such a way that coins are thrown according to the number of the members and individuals are randomly assigned to two groups, Blinding description: Patients are explained that they will be randomly assigned to one of the two groups of drugs or placebo, but they do not know which group they are in. The resident in charge of filling out the questionnaires and distributing the medicine or placebo is also not aware of them and distributes the medicine and placebo in the same containers among the patients. The same is true of the analyzer. 3 Effectiveness of duloxetine in posterior spinal fixation. Intervention 1: Intervention group: After posterior spinal fixation surgery case group receive 30 mg of duloxetine for 6 weeks. Intervention 2: Control group: : After posterior spinal fixation surgery control group receive placebo for 6 weeks. 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 At the moment, we have decided to publish the results of the study in the form of an article, but if the researchers wish, it is not forbidden to have study information by deleting the personal information of the participant.
public Arezoo Samadi
No. 3/5/1/2 ,16th Ave. Velenjak St. Tehran
Tehran Iran (Islamic Republic of) 1985738651 +98 21 2227 6936 arezoosamadi1980@yahoo.com Iran University of Medical Sciences scientific Arezoo Samadi
No. 3/5/1/2 , 16th Ave. Velenjak St. Tehran
Tehran Iran (Islamic Republic of) 1985738651 +98 21 2227 6936 arezoosamadi1980@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years old and younger than 80 with chronic low back pain (more than 3 months duration) who are candidate for posterior spinal fixation surgery. All patients have to discontinue any medication that could interfere with their pain such as nonopioid or opioid drugs , antidepressants and anticonvulsants at least for 6 months before surgery. Non pharmacological pain-relieving procedures such as acupuncture or physical therapies are not allowed during the study. 18 years 80 years Both prior use of opioids , antidepressants , drug abuse depression pregnancy and breast feeding severe coexisting diseases such as heart failure , severe hypertension , convulsion and kidney dysfunction Treatment - Drugs Placebo Intervention group: After posterior spinal fixation surgery case group receive 30 mg of duloxetine for 6 weeks. Control group: : After posterior spinal fixation surgery control group receive placebo for 6 weeks. Effectiveness of duloxetine on quality of life in chronic low back pain in patients who had posterior spinal fixation measured with SF36 questionnaire / Effectiveness of duloxetine on severity of pain in chronic low back pain in patients who had posterior spinal fixation measured with VAS questionnaire. Timepoint: all patients will fill the questionnaires at first step of study and one more 6 weeks later. Method of measurement: SF36 questionnaire / VAS questionnaire. Iran University of Medical Sciences Approved 2019-03-11 Ethics committee of Iran University of Medical Sciences No. 3/5/1, 16th velenjak St., Tehran , Iran Tehran Tehran Iran (Islamic Republic of)