]>
IRCT20150724023315N3 IRCT 2023-02-24 Tehran University of Medical Sciences The effect of ozone on low back pain Effectiveness of percutaneus epidural neuroplasty(RACZ procidures) with and without epidural OZONE injection in patients with chronic low back pain 2023-02-20 anticipated 38 Complete https://irct.ir/trial/68446 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using the randomized permutation block with Excel software. The blocks are provided to the attending physician and when each patient enters, a block envelope is randomly selected and based on the sticker removed, the patient will be assigned to the relevant treatment group, Blinding description: In this study, those who register the results of the intervention and statistical analysis are not aware of what intervention was done for each patient and each group. 2-3 chronic low back pain. Intervention 1: Intervention group(neuroplasty using the RACZ method plus ozone): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone. in this group, 10 cc of ozone 25 micrograms per cc are injected. Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education. Intervention 2: Control group(neuroplasty using the RACZ method): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone.Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education. 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 Mahmoud Ganjifard
No. 138, Nusrat St., Jamalzadeh St
tehran Iran (Islamic Republic of) 1419853851 +98 21 6119 2210 fardganj@gmail.com Tehran University of Medical Sciences scientific Mahmoud Ganjifard
No. 138, Nusrat St., Jamalzadeh St
tehran Iran (Islamic Republic of) 1419853851 +98 21 6119 2210 fardganj@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 1- Radicular back pain for at least three months that has not responded to non-invasive treatments including medicine and physical therapy. 2- The pain score based on VNS (verbal numerical scale) should be more than 4 25 years 80 years Both Patients with acute trauma and spinal fractures, malignancies rheumatic diseases pregnancy mental illnesses peripheral neuropathies hyperthyroidism coagulopathy chronic systemic infection urinary and fecal incontinence local infection of the sacrum area patient dissatisfaction favism g55.1 Nerve root and plexus compressions in intervertebral disc disorders Treatment - Drugs Treatment - Drugs Intervention group(neuroplasty using the RACZ method plus ozone): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone. in this group, 10 cc of ozone 25 micrograms per cc are injected. Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education. Control group(neuroplasty using the RACZ method): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone.Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education. Pain intensity of patients based on verbal numeric scale (VNS). Timepoint: before the intervention, twenty-four hours, one month and three months after the intervention. Method of measurement: Pain intensity assessment questionnaire. The percentage of disability due to back pain based on the OSWESTRY disability index questionnaire. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: OSWESTRY disability index questionnaire. Tehran University of Medical Sciences Approved 2023-01-28 Neuroscience Research Institute, Tehran University of Medical Sciences Keshavarz Boulevard tehran Tehran Iran (Islamic Republic of)