]>
IRCT20130523013442N39 IRCT 2026-05-11 Shahid Beheshti University of Medical Sciences Comparing the efficacy of transforaminal epidural steroid combined hyaluronic acid versus steroid combined hyaluronidase injection in improvement of function and pain related to lumbosacral disk herniation, A Randomized Clinical Trial Comparing the efficacy of transforaminal epidural steroid combined hyaluronic acid versus steroid combined hyaluronidase injection in improvement of function and pain related to lumbosacral disk herniation, A Randomized Clinical Trial 2026-04-21 anticipated 34 Complete https://irct.ir/trial/89555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two groups: steroid-hyaluronic acid injection and steroid-hyaluronidase injection in a one-to-one ratio. The selection process is as follows: the type of treatment is coded in opaque envelopes and provided to the patient by a third person outside the research team (ward secretary) on the day of the injection, based on the patient's visit. The patient hands the envelope to the performing physician in the operating room, and the type of injection will be performed for the patient based on the code specified in the envelope, Blinding description: The type of treatment is coded in opaque sealed envelopes and provided to the patient by a third party outside the research team (ward secretary) on the day of the injection, based on the patient's visit. The patient hands the envelope to the performing physician in the operating room, and the type of injection will be administered to the patient based on the code specified in the envelope. 3 lumbar disc herniation and lumbar spinal stenosis. Intervention group: steroid-hyaluronic-acid, control group:steroid-hyaluronidase. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public seyed Ahmad Raeissadat
Yadgar Imam Highway, Saadat Abad Intersection
tehran Iran (Islamic Republic of) 1998734383 +98 21 2236 0635 ahmad_raeissadat@yahoo.com Shahid Beheshti University of Medical Sciences scientific Amir hossein Mahdi kaghazi
Intersection of Yadgar-e-Imam and Saadat Abad Highways, Shahid Modarres Hospital
tehran Iran (Islamic Republic of) 1998734383 +98 21 2236 0635 amirhosseinkaghazi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients aged 20 to 65 years with a BMI <33 with radicular back pain of lumbar disc origin that has not responded to conservative treatments within 6 weeks of treatment. Positive MRI findings of intervertebral disc herniation and canal stenosis or intervertebral foramen stenosis and positive clinical tests in favor of intervertebral disc involvement and lumbar root involvement in EMG/NCS 20 years 65 years Both Neurological deficits such as muscle weakness or symptoms of cauda equina syndrome, multi-root and bilateral involvement, bone stenosis and stenosis due to ligamentous hypertrophy, history of back surgery, vascular problems of the lower extremities and vascular claudication, history of lower extremities surgery, unstable hemodynamic conditions, sensitivity to drugs used in the study, use of corticosteroids (last 2 weeks), presence of coagulation disorders or uncontrolled systemic problems, uncontrolled diabetes, uncontrolled blood pressure, presence of systemic infection or infection at the injection site, pregnancy, presence of neurological diseases such as MS. Treatment - Drugs Intervention group: steroid-hyaluronic-acid, control group:steroid-hyaluronidase . Timepoint: . Method of measurement: . Pain and function. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Pain assessment with visual analog scale, function assessment with Roland-Morris questionnaire and Oswestry Disability Index. Shahid Beheshti University of Medical Sciences Approved 2026-02-08 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran - Yadegar Imam Highway (RAH) - Saadat Abad Intersection - Shahid Modarres Hospital tehran Tehran Iran (Islamic Republic of)