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IRCT20230701058636N1 IRCT 2023-10-11 Shiraz University of Medical Sciences A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis - a randomized clinical trail A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis - a randomized clinical trail 2023-10-23 anticipated 36 Complete https://irct.ir/trial/71083 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization method is used to randomize the study. The list is sorted by the computer with the same size block and the clinic secretary divides the patients based on the list, Blinding description: Considering that the patient is unaware of the technique of performing the project and does not see the type of needle and the same drug is injected for him and the general conditions of the procedure are the same for both groups and only the technique of doing it is different: the patient, the questioner, the statistical analyst. are blind Only the performing doctor knows what kind of procedure he has performed. (The patient is blind). Clinical Caregiver: We teach the person who cares and examines how to complete the questionnaire. This person has no knowledge of the type of patient intervention. In this study, we do not have the researcher and the researcher, because the researcher gives both his studies and informs about the type of intervention in each group. Message evaluator: Questionnaires are completed to a person who is not informed about the interventions and determines the amount of pain reduction and performance increase in each person according to the questionnaire. Analysts: Finally, after completing and collecting all the information, the questionnaires are given to the person to check the information, that this person is not involved in any of the steps and how the intervention is divided. N/A Lumbosacral spinal stenosis. Intervention 1: Intervention group : including subcutaneous injection of 2 cc of 25 ml/ug ozone gas in the area of back pain at an angle of 45-degree to the sagittal plate whit 25-gage needle, for three sessions at a interval of one week. Intervention 2: Control group: - including injection of 2 cc of 25 ml/ug ozone gas at the paravertebral muscles at an angle of about 90-degree to the sagittal plate 2cm bilateral from the lumbar spinous procsses whit 22-gage needle , for three sessions at a interval of one week. 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 is no further information
public Ghazaleh Rezaeianpour
Central Building of Shiraz University of Medical Sciences, Zand Ave, Shiraz
Shiraz Iran (Islamic Republic of) 71348-14336 1017 773 919 98+ ghazalrzpdr@gmail.com Shiraz University of Medical Sciences scientific Ghazaleh rezaeianpour
Central Building of Shiraz University of Medical Sciences, Zand Ave, Shiraz
Shiraz Iran (Islamic Republic of) 71348-14336 +98 919 773 1017 ghazalrzpdr@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Completion and signing of the consent form Presence of pain and other clinical symptoms of lumbar sacral stenosis in the last six months that did not respond to conservative treatments. Age between 75-35 years old Absence of any disease around the spine 35 years 75 years Both Favism Infection involving lumbar spinal (brucella) Diabetes mellitus, Rhumatological disorder (lupuse, gout) BMI more than 41 Pregnancy Malignancy Liver disease Sensitivity reaction to test drug Malnutrition Peripheral neuropathy Bleeding disorder Galactosemia Radiculopathy Inability to communicate and complete questionnaires M48.06 Lumbosacral spinal stenosis Rehabilitation Rehabilitation Intervention group : including subcutaneous injection of 2 cc of 25 ml/ug ozone gas in the area of back pain at an angle of 45-degree to the sagittal plate whit 25-gage needle, for three sessions at a interval of one week. Control group: - including injection of 2 cc of 25 ml/ug ozone gas at the paravertebral muscles at an angle of about 90-degree to the sagittal plate 2cm bilateral from the lumbar spinous procsses whit 22-gage needle , for three sessions at a interval of one week. Pain score according to Visual Analog Scale. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: Visual Analog Scale. Patient Performance Score in Oswestry Disability Scale. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: Oswestry Low Back Pain Questionnaire. Patient Performance Score in QUEBEC Back Pain Disability. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: QUEBEC Back Pain Disability Questionnaire. Shiraz University of Medical Sciences Approved 2023-09-27 Ethics committee of Shiraz University of Medical Science Central Building of Shiraz University of Medical Sciences, Zand Ave, Shiraz Shiraz Fars Iran (Islamic Republic of)