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IRCT20111109008035N4 IRCT 2017-12-29 Kermanshah University of Medical Sciences The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain 2017-12-22 anticipated 48 Complete https://irct.ir/trial/8474 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Table of random numbers will be used, Blinding description: The participants are blind. The psychologist who will do assessment of pain intensity and also sleep quality mentally (by questionnaire) and objective (by actigraph) and the physiotherapist who will physically treat the participants are blind too. 2-3 Low Back Pain. Intervention 1: Melatonin or N-acetyl-5-methoxy tryptamine 3 milligrams per night for one month (during 20 physiotherapy sessions on alternate days). Intervention 2: Zolpidem or Ambien 5 milligrams per day for one month (during 20 physiotherapy sessions on alternate days). Yes - There is a plan to make this available What will be shared: All collected deidentified data will be shared with others. When: Starting 6 months after relative manuscript publication. To whom: Researchers working in academic institutions or people working in businesses can also apply to receive it. Conditions: No access criteria for data/documents. Where to obtain: Correspond with Dr MohammadBagher Shamsi. How to obtain: Correspond with and email to Dr MohammadBagher Shamsi. Comments:
public MohammadBagher Shamsi
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3724 1929 mbshamsi@yahoo.com Kermanshah University of Medical Sciences scientific MohammadBagher Shamsi
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3724 1929 mbshamsi@yahoo.com Kermanshah University of Medical Sciences, Iran (Islamic Republic of) Patients with non-specific low back pain who complain of insomnia and poor quality of sleep for more than 1 month. 30 years 65 years Both Herniated lumbar discopathy; malignancy; sleep apnea; psychosis; drug abuse; past history of other sleep disorders and medical problems affecting sleep quality such as diabetes mellitus & chronic renal failure. M54.9 Dorsalgia, unspecified Treatment - Drugs Treatment - Drugs Melatonin or N-acetyl-5-methoxy tryptamine 3 milligrams per night for one month (during 20 physiotherapy sessions on alternate days) Zolpidem or Ambien 5 milligrams per day for one month (during 20 physiotherapy sessions on alternate days) Sleep quality. Timepoint: At the start and end of the study. Method of measurement: Pittsburgh questionnaire and Actigraphy. Visual Analogue Scale. Timepoint: At the start and end of the study. Method of measurement: Visual Analogue Scale. Disability. Timepoint: At the start and end of the study. Method of measurement: With Oswestry disability index. Kermanshah University of Medical Sciences Approved 2017-09-27 Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)