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IRCT20200620047852N1 IRCT 2020-06-23 Iran University of Medical Sciences "Agomelatin in chronic low back pain" Comparing The Analgesic Effect Of Agomelatin Versus Placebo In Combination With Pregabalin In Patients With Chronic Low Back Pain : A Randomized , Double-Blinded Study 2020-07-06 anticipated 84 Complete https://irct.ir/trial/49042 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Clinical trial with control groups , parallel group , double-blinded, randomized with placebo(random allocation).In this study we will use Balance Block Randomization.In order to concealment happends , the tables of the groups and the drugs boxes(which includes 2types:the first one is Pregabalin with Placebo and the second one is Pregabalin with Agomelatin)will held by someone except the analyzer or interviewer.Neither the analyzer nor the interviewer do not know about the groups, Blinding description: In order to concealment happends , the tables of the groups and the drugs boxes(which includes 2types:the first one is Pregabalin with Placebo and the second one is Pregabalin with Agomelatin)will held by someone except the analyzer or interviewer.Neither the analyzer nor the interviewer do not know about the groups. 3 Chronic low back pain. Intervention 1: Intervention group: we will prescribe Pregabalin 75mg BD + Agomelatin25mg once a day.Before starting Agomelatin and in the 3rd week we will check Liver enzymes. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants. Intervention 2: Control group: we prescribe Pregabalin75mg BD + Placebo once a day. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants. Yes - There is a plan to make this available What will be shared: Participant data research's protocol Statistical analysis map Informed consent form Clinical research report Analysis's codes Data's dictionary All the datas will be available after making them unknown in order to keep the secrets of the participants. When: All data will be available after publishing the results To whom: everybody Conditions: it is allowed to do any analysis or researchs with citation. Where to obtain: the main researcher - dr shayan amiri by e-mail. amiri.shayan@gmail.com How to obtain: After receiving e-mail , i will send all the requested information within 1 week Comments:
public Shayan Amiri
No24, First West Street, 24 metres boulvard,saadat abad,tehran , iran
Tehran Iran (Islamic Republic of) 1998667133 +98 21 2236 3375 Amiri.shayan23@gmail.com Iran University of Medical Sciences scientific Shayan Amiri
No24, First West Street, 24 metres boulvard,saadat abad,tehran , iran
Tehran Iran (Islamic Republic of) 1998667133 +98 21 2236 3375 Amiri.shayan23@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with chronic low back pain without an indication for surgery.Chronic low back pain+patients with low back pain for at least 3 months(almost everyday) Patients aged between 18 to 60 18 years 60 years Both Patiens with long term usage of Opioids , Anti depressants , Benzodiazepines,Gabaergic drugs Any contraindications for using each drugs(Agomelatin or Pregabalin) Liver enzymes three times more than normal Patients with depression disorder or suicidal thoughts or psychosis or acute manic phase or cognitive disorder or anxiety disorder or PTSD who needs treatment. These patients will exclude by an interview done by an educated psycholoy resident due to DSM5 Patients who need surgery will exclude PAtients who are taling any Anti-depressants drugs Patients who took Pregabalin within 1 month Patients who are taking physiotherapy courses will exclude Life expectancy under 12 month Patients who are pregnant or during breastfeeding period M54.5 Low back pain Treatment - Drugs Treatment - Drugs Intervention group: we will prescribe Pregabalin 75mg BD + Agomelatin25mg once a day.Before starting Agomelatin and in the 3rd week we will check Liver enzymes. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants. Control group: we prescribe Pregabalin75mg BD + Placebo once a day. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants. Score of pain in brief pain inventory scale (BPI) questionnaire. Timepoint: The beginning of the the study and 1st,4th,8th week. Method of measurement: Brief pain inventory scale (BPI) questionnaire. Roland-Morris Disability Questionnaire (RMDQ). Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Roland-Morris Disability Questionnaire (RMDQ). Score of anxiety and depression by The Hospital Anxiety and Depression Scale (HADS). Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Roland-Morris Disability Questionnaire (RMDQ). Evaluating the health and function of the patients using SF-36 questionnaire. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: SF-36 questionnaire. Evaluating the psychologic status of the patients using GHQ-28 questionnaire. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: GHQ-28 questionnaire. Evaluating the demographic variables using the questionnaire designed by the researcher. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Questionnaire designed by researcher. Evaluating the drugs complications by drug checklist designed by researcher. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: drug check list designed by the researcher. Iran University of Medical Sciences Approved 2020-06-17 Ethics committee of Iran university of medical sciences No 24- First west street -24 metres boulvard-saadat abad-tehran - iran Tehran Tehran Iran (Islamic Republic of)