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IRCT20100827004641N17 IRCT 2020-08-26 Tabriz University of Medical Sciences Comparison of the effect of ozone, corticosteroid and prolotherapy in coccydynia Comparison of the effect of ultrasound-guided topical ozone injection, corticosteroid injection and prolotherapy on pain intensity in patients with coccydynia: A prospective, double-blind, multicenter randomized clinical trial 2020-01-18 anticipated 42 Complete https://irct.ir/trial/50006 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly divided into three treatment groups using a table of random numbers and a centralized randomization method. In order to execute the randomization process to create a random sequence and to perform the random allocation process we will use RAS software which will be created by a statistician. Two hours before the patient's visit for injection, the person responsible for injection will contact the statistician by phone or text message and will ask her about the random assignment of the participant to a specific group, Blinding description: The injection material is prepared in the syringe without informing the patient and the syringes will be covered with an aluminum foil so that the participant does not know the type of injection material. Patients will be prohibited from receiving any NSAIDs or analgesics for a 15-day wash-out period prior to enrollment and intervention. Due to the different nature of ozone (gas), during the injection, there is a possibility that the injector will acknowledge the nature of this medical substance. The person responsible for outcome measures and the person responsible for the statistical analysis are also kept blind. 3 Coccydynia. Intervention 1: Intervention group one: Ozone (O2-O3), 12 micro-gram, one time ultrasound guided injection inside the sacrococcygeal area. Intervention 2: Intervention group two: Corticosteroid, 40 mg Methylprednisolone, one time ultrasound guided injection inside the sacrococcygeal area. Intervention 3: Intervention group three: Prolotherapy (Dextrose 20 %), one time ultrasound guided injection inside the sacrococcygeal area. 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 No more information
public Bina Eftekharsadat
Imam Reza Medical Research & Training Hospita; Golgasht avenue; Daneshgah street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1330 3193 binasadat@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Bina Eftekharsadat
Rehabilitation ward, Imam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1330 3193 binasadat@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of coccydynia Age of 18-65 years Pain score ranging from 1 to 10 in visual analogue scale 18 years 65 years Both Tumors of the cauda equina Pelvic surgery Herniation of the lumbosacral disc M53.3 Sacrococcygeal disorders, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group one: Ozone (O2-O3), 12 micro-gram, one time ultrasound guided injection inside the sacrococcygeal area Intervention group two: Corticosteroid, 40 mg Methylprednisolone, one time ultrasound guided injection inside the sacrococcygeal area Intervention group three: Prolotherapy (Dextrose 20 %), one time ultrasound guided injection inside the sacrococcygeal area Pain intensity. Timepoint: Evaluating the visual analogue scale at the beginning of the study (before intervention) and 7 and 60 days after injection. Method of measurement: Visual analogue Scale. Overall recovery rate. Timepoint: Evaluating the overall recovery rate at 7 and 60 days after injection. Method of measurement: Patient Global Impression of Improvement. Tabriz University of Medical Sciences Approved 2020-01-18 Iran University of Medical Sciences Iran University of Medical Sciences; next to Milad Tower; Hemmat Highway Tehran Tehran Iran (Islamic Republic of)