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IRCT20200209046437N1 IRCT 2020-04-23 Tehran University of Medical Sciences Evaluation of two steroid injection methods on drug distribution Comparison between two steroid administration methods into the epidural space (Trans-formalin and inter laminar) on drug volume distribution to the anterior epidural space in patients with chronic radicular pain 2019-08-02 anticipated 64 Complete https://irct.ir/trial/45752 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomize allocation Patients will be randomly introduce to the two determined groups : trans-formalin and parasitical inter-laminar. randomize allocation method for the two groups is block randomization, as lo block size has been considered 6 persons. And the patient assignment sequences will be determined to the groups by Random allocation software, , and this sequence will be kept by the project manager. None of the participants in this study will be aware of the randomization method also in order to conceal the randomization process, color folders with sequentially specific number will be used , These folders will be held by the project manager who is aware of the assigned treatment groups, Blinding description: Patients are not aware about that they are going to be assigned in which study group .The doctor who performs the block is different from the doctor who reviews the outcome of the study. So the physicians who study the outcome are not aware of the patients in the study groups. It is important to say that distribution of Radio contrast agent into the epidural space will be done by fluoroscopic examination in a completely different session from the radiologist's block. Clinical outcomes of the study (pain severity reduction and life quality changes) will also be performed by another anesthesiologist (assistant) in a different session from the block session in the clinic or by telephone follow-up. N/A Waist disc. Intervention 1: Intervention group:Epidural needle G 10 cm Tuohy-type-17 B-brown is placed on the surface of the damaged disc with loss of resistance technique and inclined to the lesion. After the needle was inserted into the omnipaque 240, 5 ml and then a mixture of 40 mg of prednisolone, 4 ml of normal saline and 5 ml of 2% lidocaine were injected into the epidural space. Intervention 2: Control group : The RF Needle, 15cm, blunt, curved needle will be inserted into the foramen under the pedicle. Then 5 ml of contrast is injected and then the combination of steroids and local anesthetic is injected. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD can be shared When: 6 months after publication To whom: People working in academic institutions and people working in businesses Conditions: Planning of similar studies in other academic centers Where to obtain: Email address How to obtain: After request during the 1-2 months Comments:
public Narges Khojasteh Kalansra
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 8898 7381 narsiskhk@yahoo.com Tehran University of Medical Sciences scientific Narges Khojasteh Kalansara
Imam Khomeini Hospital Complex,Gharib Street , end of keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6692 9234 narsiskhk@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with Herniated Disk with at least 50% remained height of the inter-vertebral disc. 35 years 70 years Both previous spine surgery record Epidural lumbar spine steroid injection in the last years M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Drugs Treatment - Drugs Intervention group:Epidural needle G 10 cm Tuohy-type-17 B-brown is placed on the surface of the damaged disc with loss of resistance technique and inclined to the lesion. After the needle was inserted into the omnipaque 240, 5 ml and then a mixture of 40 mg of prednisolone, 4 ml of normal saline and 5 ml of 2% lidocaine were injected into the epidural space. Control group : The RF Needle, 15cm, blunt, curved needle will be inserted into the foramen under the pedicle. Then 5 ml of contrast is injected and then the combination of steroids and local anesthetic is injected. Contrast distribution pattern. Timepoint: During the intervention. Method of measurement: Fluoroscopic photographs. Pain. Timepoint: Before the intervention - two weeks,1 month 3 month and 6 months after the intervention. Method of measurement: 11-point numeric scale. Change of quality of life. Timepoint: Before intervention , 2 weeks after intervention , 1 months after intervention , 3 months after intervention, 6 months after intervention. Method of measurement: SF36 Questionnaire. Tehran University of Medical Sciences Approved 2019-03-13 Ethics committee of Tehran University of Medical Sciences No 226, Central organization, Ghods Street, Keshavarz Boulva Tehran Tehran Iran (Islamic Republic of)