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IRCT20191004044980N1 IRCT 2019-11-25 Shiraz University of Medical Sciences The effect of Hyaluronidaz and Ozon on spinal canal stenosis Comparing the effectiveness of intramuscular paravertebral injection of Oxygen –Ozone and epidural injection of Hyaluronidase on pain and function in patient with lumbosacral canal stenosis 2019-10-23 anticipated 30 Complete https://irct.ir/trial/42722 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Complete randomized block design with SPSS software is used for randomization and then sealed non-transparent envelopes are used to hide the random sequence, Blinding description: Participant:The participant is explained that if they are interested, they can join our research project. Two methods used to reduce patient pain in our study are explained to the patient. Benefits and possible complications of both methods are described to the patient and the patient is told to randomly fall into one of the intervention groups. If the patient is accepted to admit the study, by random allocation software, the patient falls into one of two groups Clinical Caregiver: We teach the caregiver how to complete the questionnaire. This person is not aware of the patient's intervention. Researcher: In this study we are not capable of blinding the researcher because the researcher performs both interventions himself and is aware of any intervention in each group. Outcome Assessor: Completed questionnaires are handed to a person who is unaware of interventions and requested to determine the extent of pain reduction and performance enhancement in each individual according to the questionnaire. Data analyzer: Questionnaires are finally given to the individual after completing and collecting all the information to evaluate the information. This person is unaware of any of the steps in the study and group division and intervention allocation. 3 Lumbosacral spinal stenosis. Intervention 1: Intervention group: Injection of 18 cc Ozone-Oxygen mixture (2% _98%) at a concentration of 20 µg / dl at six points (three cc in each point) in the paravertebral muscles at 2 cm from the lumbar spine 4 and 5 and the first sacral vertebrae are injected through the nidel thin gage 22 at an angle of about 90 degrees to the sagittal plate, for three sessions at a interval of one week. Intervention 2: Control group: a single unit of hyaluronidase-1500 unit and 4 cc marcain 0.5% is injected epidurally under fluoroscope-guided epidural injection. The injection is done only one time. Yes - There is a plan to make this available What will be shared: All available data can be shared after making people unidentifiable When: Start access period one year after publishing the results To whom: Everyone can access to this information Conditions: If the information in this study helps to improve the science process. Where to obtain: reyhaneh.parvin@gmail.com 00989171324770 How to obtain: After sending the desired message, all authors of the study will be consulted and all information will be sent within a maximum of three weeks if permitted. Comments:
public Reyhane Parvin
Atlas buildin, Alley 4, Azadi Blvd, Atlas Square, Shiraz
Shiraz Iran (Islamic Republic of) 7145647855 +98 71 5364 2641 Reyhaneh.parvin@gmail.com Shiraz University of Medical Sciences scientific Reyhane Parvin
Atlas buildin, Alley 4, Azadi Blvd, Atlas Square, Shiraz
Shiraz Iran (Islamic Republic of) 7145647855 +98 71 5364 2641 reyhaneh.parvin@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Back pain and other symptoms of spinal canal stenosis in the last six months Age between 35_75 years Confirmation of spinal canal stenosis through MRI and EDX 35 years 75 years Both Diabetes Melitus Rheumatologic and collagen vascular diseases peripheral neuropathy and nerve injury Brucellosis BMI more than 41 History of trauma and spinal fracture Bleeding disorder Allergic reaction to Bovin protein Genetic disease such as Galactose intolerance or Lactase deficiency Patient with cardiac problem Inability to communicate and complete the questionnaire History of liver ,kidney and cardiopulmonary problem History of periarticular or intraarticular in the past 6 months Pregnant women People with cancer People taking Anticoagulant Favism M48.06 Spinal stenosis, lumbar region Rehabilitation Rehabilitation Intervention group: Injection of 18 cc Ozone-Oxygen mixture (2% _98%) at a concentration of 20 µg / dl at six points (three cc in each point) in the paravertebral muscles at 2 cm from the lumbar spine 4 and 5 and the first sacral vertebrae are injected through the nidel thin gage 22 at an angle of about 90 degrees to the sagittal plate, for three sessions at a interval of one week. Control group: a single unit of hyaluronidase-1500 unit and 4 cc marcain 0.5% is injected epidurally under fluoroscope-guided epidural injection. The injection is done only one time. 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 Qestionnaire. Shiraz University of Medical Sciences Approved 2018-10-15 Ethics committee of Shiraz University of Medical Science Atlas buildin, Alley 4, Azadi Blvd, Atlas Square, Shiraz Shiraz Fars Iran (Islamic Republic of)