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IRCT20190306042945N5 IRCT 2024-08-29 Iran University of Medical Sciences Comparison of paraspinal ozone vs. oxygen injection, on low back pain Evaluation of paraspinal ozone-oxygen therapy vs. pure oxygen injection, on chronic discogenic low back pain patients’ function and pain 2024-09-22 anticipated 20 Complete https://irct.ir/trial/78237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After assigning a special code to each subject, the assignment of each code to the case or control group will be done randomly by someone other than the researcher and based on the random function of Excel software (even number = case and odd = control). For allocation concealment, based on the relevant code, the registration of patients in two control and sample groups will be done away from the reach of the researcher, and until after the end of the treatment and the analysis, the patient and the therapist will not know the type of treatment (ozone+oxygen or pure oxygen), Blinding description: Regarding the double-blindness of this study, it should be noted that all patients receive apparently similar treatment (the appearance and details of the intervention are completely identical for the sample group and the control group) and despite the patient's knowledge of participating in the trial study, being in the control group or the sample group will not be known. 2-3 Chronic low back pain. Intervention 1: Intervention group: Three sessions of paraspinal intramuscular injection of ozone with a dose of 20ug/ml and a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection. Intervention 2: Control group: Three sessions of paraspinal intramuscular injection of oxygen gas with a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individual ID data When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: If needed, for use in future researches, please send a written request via email Where to obtain: Main researcher: Dr. Bijan Forough Email: forogh.b@iums.ac.ir How to obtain: After sending the request to the e-mail, the information will be accessible within a period of about one week Comments:
public Bijan Forogh
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 8214 1612 forogh.b@iums.ac.ir Iran University of Medical Sciences scientific Bijan Forogh
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 8214 1612 forogh.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with BMI less than 35 Complaint of low back pain (local or radicular) that has lasted for more than 3 months Pain intensity based on VAS should be higher than 4 Disorder in at least one of the lumbar spinal discs (L2-S1) that is evident in MRI The patient's willingness to participate in the research project 45 years 60 years Male History of any lumbar spine surgery Receiving interventional treatments for back pain during the last six months The presence of ozone therapy contraindications (G6PD, sickle cell anemia, uncontrolled thyroid disorder, pregnancy, breastfeeding, uncontrolled hypoglycemia, etc.) The patient's back pain can be justified by any reason other than lumbar disc disorders Exacerbation of back pain in the patient with neurological defects such as weakness, loss of deep reflexes Occurrence of urinary and stool control disorders and numbness of the perineum Drug and alcohol addiction Patients with major depression or significant psychiatric and mental diseases (such as needle phobia, etc.) History of tumor or local infection of the lumbar region History of malignant diseases (multiple myeloma, bone metastases, leukemia and lymphoma) Use of medication or other treatment for back pain during the study Non-referral to record the desired scales during the follow-up period Presence of multilevel disc involvement and lumbar spinal canal stenosis in more than two levels M54.5 Low back pain Treatment - Drugs Treatment - Drugs Intervention group: Three sessions of paraspinal intramuscular injection of ozone with a dose of 20ug/ml and a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection. Control group: Three sessions of paraspinal intramuscular injection of oxygen gas with a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection. Patient's pain intensity with Visual Analogue Scale. Timepoint: before, during the last intervention session, after one month and three months after completing three intervention sessions. Method of measurement: Completion of the Visual Analogue Scale by the patient. Functional impairment of the patient based on the Oswestry Disability Index. Timepoint: before, during the last intervention session, after one month and three months after completing three intervention sessions. Method of measurement: Completion of the Oswestry Disability Index questionnaire by the patient. Iran University of Medical Sciences Approved 2024-07-08 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor, next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)