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IRCT20101113005172N5 IRCT 2023-02-14 Shiraz University of Medical Sciences Evaluation of cervical epidural steroid injection in the Improvement of patients with upper extremity radicular pain due to cervical discopathy Evaluation of changes in electromyography findings before and after treatment in patients with upper extremity radicular pain due to cervical discopathy which has been treated with cervical epidural steroid injection 2023-03-01 anticipated 40 Complete https://irct.ir/trial/67899 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Cervical discopathy. Intervention group:Changes in electromyography findings before and after Interlaminar epidural injection (including: methylprednisolone 40-80 mg combined with bupivacaine 0.2% at a total volume of 6ml, under fluoroscopic guidance at the C4-C5 or C5-C6 level, via an 18G Tuohy epidural needle) will be reviewed.. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy
public Mahsa Tahvili
Anesthesiology Department, Faghihi Hospital, Zand Street
shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 tahvili_m@yahoo.com Shiraz University of Medical Sciences scientific Saman Asadi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 asadisa@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patients with chronic neck pain(more than 3 months), caused by disc herniation or central spinal stenosis, according to the clinical criteria and MRI findings 18 years no limit Both All red flags for spinal pain (inflammation, malignancy, spinal fracture, myelopathy, Cauda equina syndrome) Serious coexisting neurological or musculoskeletal disorders Serious comorbidities (renal or hepatic failure, severe heart failure, severe respiratory disease, vascular insufficiency ) Rheumatoid arthritis Ankylosing spondylitis or other rheumatological diseases Prior cervical spinal surgery Prior cervical epidural injections during last year All contraindications to epidural injections ( Systemic infection or local infection at the site of injection, bleeding diathesis or full anticoagulation, significant allergic reaction/hypersensitivity to contrast, anesthetic, … ) Critical level of spinal stenosis. All contraindications to steroids or Non-steroidal anti-inflammatory drugs Age less than 18 years Pregnancy Patient’s refusal M50.10 Cervical disc disorder with radiculopathy, unspecified cervical region Treatment - Drugs Intervention group:Changes in electromyography findings before and after Interlaminar epidural injection (including: methylprednisolone 40-80 mg combined with bupivacaine 0.2% at a total volume of 6ml, under fluoroscopic guidance at the C4-C5 or C5-C6 level, via an 18G Tuohy epidural needle) will be reviewed. Pain. Timepoint: 10 to 15 days before epidural steroid injection and 1, 3 and 6 months after epidural steroid injection. Method of measurement: In respect to standardized questionnaire. Electromyogram. Timepoint: 10 to 15 days before epidural steroid injection and 1, 3 and 6 months after epidural steroid injection. Method of measurement: In respect to standardized questionnaire. Shiraz University of Medical Sciences Approved 2022-07-19 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)