Comparative effectiveness of triamcinolone alone versus triamcinolone and hyaluronidase or triamcinolone with erythropoietin in epidural injections for lumbosacral radiculopathy: A randomized controlled trial

Comparing the effect of epidural injection of triamcinolone, combination of triamcinolone and hyaluronidase or erythropoeitin on clinical symptioms of patients with lumbosacral radiculopathy

This study is a randomized controlled trial with three parallel groups, double-blind, and phase 2, which will be conducted on 90 patients with lumbosacral radiculopathy at Baghiatallah Hospital. Randomization wil be done with the www.randomization.com website.

This prospective study will be conducted on 90 patients with lumbar radiculopathy at Baqiyatallah Hospital. The study follows a double-blind design; both the physician and patient will be unaware of the type of medication.

Inclusion criteria: chronic low back pain for > 12 weeks without motor deficit, failed conservative treatment for > 4 months, Visual analuge score > 4, Oswerty Disability Scale > 45 Exclusion criteria: Low back pain with motor deficit, history of neuropathy, myopathy, motor neuron diseases, rheumatologic diseases, collagenosis, diabetes mellitus, cancer or vertebral fractures, history of epidural injection or placement of epidural catheters, Discogel injection or percutaneous laser disk decompression

After positioning the patient in the prone position, the sacral hiatus will be identified using both anteroposterior and lateral views with fluoroscopy guidance. A spinal needle will be inserted at the level of the third sacral vertebra. The first group will receive 80 mg of triamcinolone , 2 mg of ropivacaine , and 10 cc of 5% saline. The second group will receive 80 mg of triamcinolone , 2 mg of ropivacaine , and 1500 IU (1 vial) of hyaluronidase. The third group will receive 80 mg of triamcinolone , 2 mg of ropivacaine, 4000 IU of erythropoietin, and 10 cc of 5% saline.

Pain (VAS), disability (ODI)

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.

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.

All gathered datas will be available for reseachers after emitting the name of the patients. Researchers can contact us at jusef.yvd@gmail.com.

starting 6 months after publication

Only available for people working in academic institutions.

Only available for people working in academic institutions. Using data in review articles is allowed.

All gathered datas will be available for reseachers after emitting the name of the patients. Researchers can contact us at jusef.yvd@gmail.com.

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.