]>
IRCT20180729040636N1 IRCT 2019-01-14 Esfahan University of Medical Sciences Effect of Corticosteroid in Lumbar Spinal Canal Stenosis Investigating The Effects of Short Term Oral Corticosteroid Treatment in Patients with Acquired Lumbar Canal Stenosis. 2019-01-18 anticipated 100 Complete https://irct.ir/trial/34851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were allocated into intervention or control group using block randomization method to keep an even randomization ratio of (1:1). If the patient had inclusion criteria and did not excluded from the study according to above mentioned protocol, the random number generating software was used to determine their designated group. Numbers were between 0-9. If the number was even, the letter "A" was wrote at the top of their checklist by the examining physician, and if the number was odd, the letter "B" was used. Then, the next patient had to be assigned to the opposite group. This process repeated for the upcoming patients and continued until we reached our estimated sample size. After completing the study and before starting the data analysis process, the encrypted letters were revealed by the pharmaceutical company. The letter "A" was assigned to the intervention group and the letter "B" was assigned to the control group, Blinding description: This study was conducted with double-blinded method. Neither the patients who were included in this study nor the researchers knew about the assignments of groups to either intervention or control. After determining the designated letter, the patients were visited by another researcher who gave the drugs to the patients. A blinded pharmacist who worked in our university hospital pharmacy bought the drugs from the pharmaceutical companies, put them in the designated group ("A" (intervention) or "B" (control) according to the pharmaceutical company policies), and gave the specific package of drugs to the patients (both of them had three active drugs, prednisolone or placebo were different between those bags) with full information of how to use them. 2 Acquired Lumbar Spinal Canal stenosis. Intervention 1: Intervention Group: Prednisolone 10 mg per day for one week, Meloxicam 7.5 mg per day, Vitamin E 400 IU and Pantoprazole 20 mg for 20 days. Intervention 2: Control Group: Meloxicam 7.5 mg per day, Vitamin E 400 IU and Pantoprazole 20 mg for 20 days, and placebo for 10 days. 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 No more information.
public Hossein Akbariaghdam
Kashani Hospital
Esfahan Iran (Islamic Republic of) 8183983434 +98 31 3620 2085 Akbariaghdam@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hossein Akbariaghdam
Kashani Hospital, Kashani Street, Isfahan
Esfahan Iran (Islamic Republic of) 8183983434 +98 31 3620 2085 Akbariaghdam@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Written Consent to Enter Study Age Over 18 Years Acquired Lumbar Spinal Canal Stenosis No History of Corticosteroid Susceptibility 18 years no limit Both Concomitant With Other Systemic Diseases, Such as Blood pressure, Diabetes, BMI>30 kg/m2, Gastroesophageal reflux disease, dyspepsia, renal failure, neuromuscular disorders History of Corticosteroid Use in The Last Three Months. Needing spinal surgery for Acquired Spinal Canal Stenosis Recent infection within 3 months ago or hospital admission for the same reasons Incidence of drug complications/severe allergic reaction to oral corticosteroid history of any surgery on the spine history of gastrointestinal bleeding M48.06 Spinal stenosis, lumbar region Treatment - Drugs Treatment - Drugs Intervention Group: Prednisolone 10 mg per day for one week, Meloxicam 7.5 mg per day, Vitamin E 400 IU and Pantoprazole 20 mg for 20 days Control Group: Meloxicam 7.5 mg per day, Vitamin E 400 IU and Pantoprazole 20 mg for 20 days, and placebo for 10 days Walking Distance. Timepoint: Before the Intervention and 2 Months Later. Method of measurement: Metre. Oswestry Disability Index from Oswestry Low Back Pain questionnaire. Timepoint: Before the Intervention and 2 Months Later. Method of measurement: OSWESTRY LOW BACK PAIN SCORE QUESTIONNAIRE. Severity of pain. Timepoint: Before the Intervention and 2 Months Later. Method of measurement: PAIN Numerical Rating Scale. Low Back Pain. Timepoint: Before the Intervention and 2 Months Later. Method of measurement: Check List. Esfahan University of Medical Sciences Approved 2018-09-01 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences & Health Services, Building No. 4, Hazar Jarib Street Esfahan Isfehan Iran (Islamic Republic of)