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IRCT20260926071198N1 IRCT 2026-10-27 Bagheiat-allah University of Medical Sciences The comparative efficacy of triamcinolone and combination of triamcinolone and erythropoietin and triamcinolone or triamcinolone and hyaluronidase in epidural injection for lumbosacral radiculopathy Comparative effectiveness of triamcinolone alone versus triamcinolone and hyaluronidase or triamcinolone with erythropoietin in epidural injections for lumbosacral radiculopathy: A randomized controlled trial 2026-10-23 anticipated 99 Recruiting https://irct.ir/trial/93656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to one of three groups: Group A will receive triamcinolone, Group B will receive triamcinolone and erythropoietin, and Group C will receive triamcinolone and hyaluronidase. The randomization process will utilize the website www.randomization.com. A simple randomization method will be employed, with each participant being treated as an individual unit of randomization. After randomization the results will be given to an anesthesiologist assistant who is not involved in this study and is responsible for prepering the injectant. The physical medicine and rehabilitation specialist and the patient will be blinded to the type of drug. The anesthesiologist assistant will open the pocket and prepare the drug outside the operating room. The drug which is same in volume and appearance in all three groups will then be provided for the physician, Blinding description: After randomization the results will be given to an anesthesiologist assistant who is not involved in this study and is responsible for prepering the injectant. The physical medicine and rehabilitation specialist and the patient will be blinded to the type of drug. The anesthesiologist assistant will open the pocket and prepare the drug outside the operating room. The drug which is same in volume and appearance in all three groups will then be provided for the physician. 3 Lumbosacral radiculopathy. Intervention 1: Control Group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 10 cc of 5% saline. Intervention 2: Intervention group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 1500 IU hyaluronidase diluted in 10cc of 5% saline. Intervention 3: Intervention group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 4000 IU erythropoitin diluted in 10cc of 5% saline. Yes - There is a plan to make this available What will be shared: All gathered datas will be available for reseachers after emitting the name of the patients. Researchers can contact us at jusef.yvd@gmail.com. When: starting 6 months after publication To whom: Only available for people working in academic institutions. Conditions: Only available for people working in academic institutions. Using data in review articles is allowed. Where to obtain: All gathered datas will be available for reseachers after emitting the name of the patients. Researchers can contact us at jusef.yvd@gmail.com. How to obtain: All gathered datas will be available for reseachers after emitting the name of the patients. Researchers can contact us at jusef.yvd@gmail.com. The information will be provided for researchers in aproximatly 2 weeks. Comments:
public Reza Yousefvand
Department of physical medicine and rehabilitation, baghiatallah hospital, Mollasadra st, Tehran,. Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 916 629 4147 josef.yvd@gmail.com Bagheiat-allah University of Medical Sciences scientific Reza Yousefvand
Department of physical medicine and rehabilitation, baghiatallah hospital, Mollasadra st, Tehran,. Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 916 629 4147 josef.yvd@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age>18 y Body mass index less than 40 kg/m2 Chronic low back pain for more than 12 weeks Unsuccesful conservative treatment for at least 4 months (at least one nonpharmacological and two pharmacological treatment) At least six weeks since the last intramascular corticosteroid injection At least four weaks since the last physiotherapy session Pain levels more than 4 on the visual analog scale Disability score more than 45 on the Oswerty Disability Scale 18 years no limit Both Chronic low back pain with motor deficit History of rheumatologic disease, Diabetes and liver disease Cancer Fracture in vertebral body Usage of immunosuppresive drugs Long term use of corticosteroids Uncontroled cardiopulmonary diseases Coagolopathy History of epidural catether placement Allergy to contrast, local steroids or hyaluronidase Pregnancy History of neuropathy, myopathy or motor neuron disease G55 Nerve root and plexus compressions in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs Control Group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 10 cc of 5% saline. Intervention group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 1500 IU hyaluronidase diluted in 10cc of 5% saline. Intervention group: After positioning the patient in the prone position, the sacral hiatus will be located using fluoroscopy guidance in both anteroposterior and lateral views. Under sterile conditions, 2 ml of 2% lidocaine will be injected for local anesthesia. An 18-gauge spinal needle will then be inserted, positioning the tip at the third sacral vertebra. The correct placement will be confirmed using fluoroscopy guidance. Following this, the following materials will be injected: 80 mg of triamcinolone (2 cc), 2 mg of ropivacaine (10 cc), and 4000 IU erythropoitin diluted in 10cc of 5% saline. Pain. Timepoint: before intervention and 2 weeks, 3 months and 6 months after intervention. Method of measurement: Visual analouge score. Disability. Timepoint: before intervention and 2 weeks, 3 months and 6 months after intervention. Method of measurement: Oswerthy Disability Scale. Frequency of analgesic use per week. Timepoint: before epidural injection, 2 weeks, 3 months and 6 months after epidural injection. Method of measurement: Check list. Need for medication to initiate sleep. Timepoint: before epidural injection, 2 weeks, 3 months and 6 months after epidural injection. Method of measurement: Check list. Bagheiat-allah University of Medical Sciences Approved 2026-08-10 Ethics committee of Baghiatollah University of Medical Sciences Physical medicine and rehabilitation department, Baghiatollah Hospital, Mollasadra St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)