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IRCT20120814010599N29 IRCT 2021-04-21 Iran University of Medical Sciences Comparing the clacitonin transforaminal epidural injection with caudal epidural injection in degenerative spinal canalstenosis Evaluation the effects of clacitonin transforaminal epidural injection with caudal epidural injection in patients with degenerative spinal canalstenosis; a double-blinded randomized clinical trial 2021-04-30 anticipated 40 Complete https://irct.ir/trial/55735 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients, using random allocation software, were randomly divided into clacitonin transforaminal epidural injection with caudal epidural injection. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers, Blinding description: The outcome assessor and the statistical analyzer were unaware that the patient was exposed to the clacitonin transforaminal epidural injection with caudal epidural injection. The groups are provided to the statistical analyzer in the form of codes A and B for analysis. 3 Pain. Intervention 1: Intervention group 1: In the calcitonin epidural caudal group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company). Intervention 2: Intervention group 2: In the clacitonin transforaminal epidural group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences scientific Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1433933111 +98 21 6650 9059 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Chronic low back pain with a history of more than six months with or without dissemination to the lower extremity Moderate to high pain (pain score over 3) Age between 40 to 70 years Lack of proper response to drug treatments and conservative for three months Absence of protruding disc Severe channel tightness Lack of reduction in vertebral height be more than 60% 40 years 70 years Both Severe spinal deformity Spinal tumors Spinal fracture Local or systemic infection Anticoagulant drug use History of severe mental illness Pregnancy and lactation Patient dissatisfaction G89 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group 1: In the calcitonin epidural caudal group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company). Intervention group 2: In the clacitonin transforaminal epidural group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company). Pain. Timepoint: Four times including two weeks later, 1 month, 3 months and 6 months after surgery. Method of measurement: Visual analogue scale. Inability to stand due to pain. Timepoint: Four times including two weeks later, 1 month, 3 months and 6 months after surgery. Method of measurement: Oswestry Low Back Pain Disability questionnaire. Iran University of Medical Sciences Approved 2021-04-18 Ethics committee of Iran University of Medical Sciences. Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat exp way Tehran Tehran Iran (Islamic Republic of)