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IRCT20201028049175N5 IRCT 2021-03-01 Arak University of Medical Sciences Effect of 5% dextrose epidural injections in reducing chronic low back pain Effect of 5% dextrose epidural injections in reducing chronic low back pain 2021-04-04 anticipated 150 Complete https://irct.ir/trial/54438 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into three groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method, Blinding description: Patient blindness: Drugs in 3 groups are similar in shape and feature. Blindness of person who fill the check lists: Drugs will be ordered and injected by anesthesiologists so the person who fill the check lists will unaware about kind of drug inject to each patient. Analyzer blindness: Data of the patients except kind of drug received will be delivered to analyzer. 2 Chronic low back pain. Intervention 1: Intervention group:In first group (Dextrose) 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days. Intervention 2: Intervention group:In second group (local anesthesia) 15cc of Marcain 0.5% will be injected to epidural space in 0,7,15,30 days. Intervention 3: Intervention group:In third group (combined) 10 cc of Marcain 0.5% and 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days. 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 are no more data.
public Alireza Kamali
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Ali Nazemi Rafi
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 nazemirafie.ali@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Moderate to severe low back pain (5 or more in VAS(Visual Analogue Scale)) for at least 6 months. Able to seating position Do not response to common treatment Patients with 20-75 years old 20 years 75 years Both Progressive weakness Recent bladder or intestinal dysfunction Local infection Unstable psychological disorders Other chronic pains such as pain of upper extremities Anticoagulation state Pregnancy Indication of surgery Underlying disease such as cardiovascular, renal or severe pulmonary disorders M54.9 Dorsalgia, unspecified Treatment - Other Treatment - Drugs Treatment - Drugs Intervention group:In first group (Dextrose) 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days. Intervention group:In second group (local anesthesia) 15cc of Marcain 0.5% will be injected to epidural space in 0,7,15,30 days. Intervention group:In third group (combined) 10 cc of Marcain 0.5% and 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days. Patients pain score. Timepoint: In recovery (15 minutes after injection), 2,4,12,24 and 48 hours after injections and after last injection every week till one month and then every month for three months. Method of measurement: VAS (Visual Analogue Scale). Arak University of Medical Sciences Approved 2021-01-31 Ethics committee of Arak University of Medical Sciences Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street Arak Markazi Iran (Islamic Republic of)