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IRCT20241015063370N1 IRCT 2025-03-14 Iran University of Medical Sciences Effect of adding caudal nerve block to lumbar disc laser The effect of adding caudal neuroplasty to percutaneous laser disc decompression(PLDD) in the management of lumbar radiculopathy, a double-blind randomized clinical trial 2024-01-21 anticipated 44 Complete https://irct.ir/trial/79582 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Block randomization is conducted. At the time of the first visit to the pain clinic, one of the colleagues will place the code for the first 20 patients in one envelope as Group A and the code for the next 20 patients in another envelope as Group B. This colleague will not participate in the follow-up of patients. Blinding: Another colleague of the project, who is responsible for evaluation, data collection, and follow-up, will be unaware (blind) of the method of patient group randomization. Another project colleague, responsible for the therapeutic intervention, will be unaware (blind) of the grouping or the materials used, Blinding description: Blinding: Another colleague of the project, who is responsible for evaluation, data collection, and follow-up, will be unaware (blind) of the method of patient group randomization. Another project colleague, responsible for the therapeutic intervention, will be unaware (blind) of the grouping or the materials used. Patients will be unaware and blinded to the type of treatment method. They will know that they will be randomly assigned to one of the two study groups, but they will not know which treatment method will be provided in each group. Patients will be allocated to one of the two groups using a random number table. The data collector, analyst, and outcome evaluator will gather and analyze information based on Groups A and B and will remain unaware of the type of treatment in the groups, maintaining their blinding. N/A The effect of adding caudal neuroplasty to percutaneous laser disc decompression in the management of lumbar radiculopathy a double-blind randomized clinical trial. Intervention 1: Intervention group A: After IV access for crystalloids injection, midazolam (1 mg) is initially administered intravenously for sedation. Initial standard monitoring with non-invasive arterial blood pressure, electrocardiogram, and pulse oximetry is performed. The patient is positioned prone on the operating room table under sterile conditions, and with C-arm imaging guidance, the target disc is identified. After local anesthesia, an 18-gauge disc needle is advanced through the skin in an oblique view with C-arm guidance into the disc. The correct placement of the needle tip is confirmed with AP and lateral views of the C-arm. Then, the needle mandrel is removed, and a laser fiber is inserted through the needle into the disc. The laser is applied with the following specifications: wavelength of 980 nanometers, power of 7 watts, pulse duration of 60 seconds, and interval of 1 second, until a total energy of 1500 joules is delivered. Following the laser energy application, 40 micrograms of ozone in 10 milliliters is injected into the disc through the same needle, and the needle is then withdrawn. This concludes the lumbar disc decompression procedure. Afterward, if the patient has stable hemodynamics, no sensory or motor disturbances, is conscious, can tolerate fluids, and has no complications, they are discharged from recovery. Upon discharge, all patients are prescribed pregabalin 75 mg and vitamin B-1 with a dose of 300 mg. Analgesics are recommended for pain above 3, including oral diclofenac 100 mg, up to 2 tablets per day. Intervention 2: Intervention group B: All procedures are the same as in the first group, with the only difference being that after the injection of ozone into the disc, caudal neuroplasty is performed as follows. In the lateral view of the C-arm, under local anesthesia, an 18-gauge caudal needle is inserted into the sacral hiatus, and after the injection of 1 ml contrast agent (Visipaque), the caudal neuroplasty injection solution, which includes 5 ml of 0.2% ropivacaine and 5 ml of normal saline containing 80 mg of triamcinolone, and 1500 units of hyaluronidase, is administered. Yes - There is a plan to make this available What will be shared: All data is shareable. When: Access period will begin 6 months after the publication of results. To whom: It will only be available to researchers working in academic and scientific institutions. Conditions: Any use that aids patients and advances medical science, while adhering to medical ethics, is permissible. Where to obtain: For obtaining the documents, contact ktynshrvni@gmail.com or visit the Pain Research Center at Rasoul Akram Hospital, located in Tehran, Sattarkhan Street, Niyayesh Street, Dr. Farnad Imani. How to obtain: After submitting a clear written request and stating the purpose of data access, the data will be provided within 2 weeks upon approval. Comments:
public Prof. Dr. Farnad Imani
Anesthesiology And Pain Management Research Center,Rasoul Akram Hospital, Niyayesh St,Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2107 farnadimani@yahoo.com Iran University of Medical Sciences scientific Prof. Dr. Farnad Imani
Anesthesiology And Pain Management Research Center,Rasoul Akram Hospital, Niyayesh St,Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2107 farnadimani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Age between 30-70years old low back pain radiating to the lower limb for 3 months without response to maintenance treatment Disc buldging in MRI Informed consent 30 years 70 years Both Previous surgery at the same disc level Caudaequina syndrome Vertebral listhesis Tumor Infection Vertebral fracture Pregnancy Severe mental and physical illness Dissatisfaction M54.1 Radiculopathy Treatment - Other Treatment - Other Intervention group A: After IV access for crystalloids injection, midazolam (1 mg) is initially administered intravenously for sedation. Initial standard monitoring with non-invasive arterial blood pressure, electrocardiogram, and pulse oximetry is performed. The patient is positioned prone on the operating room table under sterile conditions, and with C-arm imaging guidance, the target disc is identified. After local anesthesia, an 18-gauge disc needle is advanced through the skin in an oblique view with C-arm guidance into the disc. The correct placement of the needle tip is confirmed with AP and lateral views of the C-arm. Then, the needle mandrel is removed, and a laser fiber is inserted through the needle into the disc. The laser is applied with the following specifications: wavelength of 980 nanometers, power of 7 watts, pulse duration of 60 seconds, and interval of 1 second, until a total energy of 1500 joules is delivered. Following the laser energy application, 40 micrograms of ozone in 10 milliliters is injected into the disc through the same needle, and the needle is then withdrawn. This concludes the lumbar disc decompression procedure. Afterward, if the patient has stable hemodynamics, no sensory or motor disturbances, is conscious, can tolerate fluids, and has no complications, they are discharged from recovery. Upon discharge, all patients are prescribed pregabalin 75 mg and vitamin B-1 with a dose of 300 mg. Analgesics are recommended for pain above 3, including oral diclofenac 100 mg, up to 2 tablets per day. Intervention group B: All procedures are the same as in the first group, with the only difference being that after the injection of ozone into the disc, caudal neuroplasty is performed as follows. In the lateral view of the C-arm, under local anesthesia, an 18-gauge caudal needle is inserted into the sacral hiatus, and after the injection of 1 ml contrast agent (Visipaque), the caudal neuroplasty injection solution, which includes 5 ml of 0.2% ropivacaine and 5 ml of normal saline containing 80 mg of triamcinolone, and 1500 units of hyaluronidase, is administered. Assessment of Pain Intensity. Timepoint: before intervention, two weeks after, one month after, three months after intervention. Method of measurement: Visual Analogue Scale. Lasegue. Timepoint: before intervention, two weeks after, one month after, three months after intervention. Method of measurement: The test in which raising the leg creates pain in the lower limb and the angle at which the pain is generated is recorded. Level of function (disability) in activities of daily living. Timepoint: before intervention, two weeks after, one month after, three months after intervention. Method of measurement: The Oswestry Disability Index (ODI) a questionnaire which gives a subjective percentage scorelevel of function (disability) in activities of daily living in those rehabilitating from low back pain. Amount Of Painkillers Consumption. Timepoint: before intervention, two weeks after, one month after, three months after intervention. Method of measurement: It is recorded by a questionnaire. Iran University of Medical Sciences Approved 2024-01-01 Ethic committee of Iran University of Medical Science Hemat Highway next to Milad TowerŲŒEthic Committee of Iran University of Medical Science Tehran Tehran Iran (Islamic Republic of)