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IRCT20240827062876N1 IRCT 2024-09-05 Ghoum University of Medical Sciences Epidural injection of hyaluronidase in failed back surgery syndrome FBSS Comparison of two doses of hyaluronidase in the outcome of epidural steroid injection in patients with failed back surgery syndrome 2024-11-20 anticipated 40 Complete https://irct.ir/trial/78730 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (40 samples), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group, Blinding description: Based on the block randomization method, patients will be divided into two control and intervention groups of 20 people. In a group of anesthesiologists who will not know the type of research, patients will be given epidural injections under one of two doses of the drug based on the sealed envelope in which the drug dose is specified. The principal investigator will not know which patient is receiving which block. The patient and the person filling the questionnaire do not know the type of block. 3 Failed back surgery syndrome. Intervention 1: Intervention group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal injection of hyaluronidase 3000 IU (HYL) and triamcinolone 80 mg. Intervention 2: Control group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal hyaluronidase 1500 IU (HYL) and triamcinolone 80 mg. 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 Reza Aminnejad
Beheshti hospital; Shahid Beheshti Ave.
Ghoum Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 r.aminnejad@yahoo.com Ghoum University of Medical Sciences scientific reza aminnejad
Beheshti hospital; Shahid Beheshti Ave.
Ghoum Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 r.aminnejad@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Candidate patients to remove adhesions with medication Age older than 18 years History of epidural steroid injection in the last six months Patients who have not responded satisfactorily to 6 weeks of medical treatment despite the annoying pain NRS>=5 The presence of evidence of pressure on the lumbar spinal cord in MRI 18 years no limit Both Hyaluronidase contraindications Symptoms of cauda equina, spinal canal stenosis requiring surgery, psychosomatic disease suffering from diabetes; Suffering from rheumatic diseases and vascular collagen and gout and lupus Having nerve damage and neuropathies Suffering from bleeding diseases Inability to communicate History of allergies and allergic reactions to the drugs used History of significant liver, kidney and cardio-pulmonary disorders Pregnancy Suffering from cancers M96.1 Postlaminectomy syndrome, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal injection of hyaluronidase 3000 IU (HYL) and triamcinolone 80 mg. Control group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal hyaluronidase 1500 IU (HYL) and triamcinolone 80 mg. Pain Level. Timepoint: Two weeks, one month, three months and six months after treatment. Method of measurement: Numeric Rating Scale (NRS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe). Disability Level. Timepoint: Two weeks, one month, three months and six months after treatment. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability. Ghoum University of Medical Sciences Approved 2024-01-15 Research Ethics Committees of Qom University of Medical Sciences No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd Qom Ghoum Iran (Islamic Republic of)