]>
IRCT20110420006239N3 IRCT 2020-11-05 Tabriz University of Medical Sciences Therapeutic effects of hyalase injection on lumbar spinal canal stenosis Evaluation of the effects of hyalase injection into hypertrophic ligamentum flovum on clinical symptoms and MRI findings in lumbar spinal canal stenosis 2020-10-13 anticipated 40 Complete https://irct.ir/trial/50563 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this trial, block randomization will be used to achieve two groups with equal sample size. In order to randomize, first using the site https://www.sealedenvelope.com/simple-randomiser/v1/lists 40 codes (one code for each patient) in the form of two intervention groups with a sample size equal to the use of block sequences will be generated randomly.Each code will then be enclosed in a sealed envelope (40 envelopes in total) containing the study group information and will be kept confidential.At the time of patient admission, an envelope will be randomly assigned to each patient, and only at the time of the procedure will the physician in charge of the procedure have the right to open the envelope and view the procedure prescribed for that particular patient, Blinding description: All patients will be kept unaware of which treatment group they have been assigned to. Furthermore, the data analyst will also be unaware of study groups. 3 Lumbar Canal Stenosis secondary to Hypertrophic Ligamentum Flovum. Intervention 1: Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected into the ligamentum flavum. Intervention 2: Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected via transforaminal rout at the level of the stenosis. Yes - There is a plan to make this available What will be shared: All of the participants' data reported in the article relative to this trial after deidentification When: Immediately after publication regarding the publisher's policy To whom: Researchers who provide a methodologically sound proposal. Conditions: Any purpose Where to obtain: Dawood Aghamohamadi (daghamohamadi@yahoo.com) or Yalda Yazdani (yaldayznn@gmail.com) How to obtain: Proposals should be directed to one of the above-mentioned email addresses. Requestors also will need to sign a data access agreement. Comments:
public Dawood Aghamohamadi
Department of Anesthesiology, Imamreza Hospital, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 1994 daghamohamadi@yahoo.com Tabriz University of Medical Sciences scientific Dawood Aghamohamadi
Department of Anesthesiology, Imamreza Hospital, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 1994 daghamohamadi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Persistent Low Back Pain Lumbar Canal Stenosis Hypertrophy of Ligamentum Flovum Inefficacy of Conservative therapies Age over 18 18 years 80 years Both Laminectomy Surgery Coagulopathy Dermal Infection near the site of injection Presence of SOL in Spinal Cord Ossification and Calcification Pregnancy M48.06 Spinal stenosis, lumbar region Treatment - Drugs Treatment - Drugs Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected into the ligamentum flavum Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected via transforaminal rout at the level of the stenosis Pain intensity. Timepoint: Before injection and then one week after injection. Method of measurement: Visual Analogue Scale. Imaging findings. Timepoint: Before injection and then one week after injection. Method of measurement: MRI findings due to Severity of Lumbar Canal Stenosis. Tabriz University of Medical Sciences Approved 2020-08-11 Ethics committee of Tabriz University of medical sciences No. 6, West Kahnamuyi Ave, North Shariati St, Valiasr Blvd Tabriz East Azarbaijan Iran (Islamic Republic of)