Investigating The Effects of Short Term Oral Corticosteroid Treatment in Patients with Acquired Lumbar Canal Stenosis.

The Therapeutic Effect of Short Term Oral Corticosteroid Treatment in Patients with Acquired Lumbar Canal Stenosis.

Double-blinded Randomized Placebo-Controlled Clinical Trial

Patients with clinical sign and symptoms of acquired lumbar spinal stenosis referred to the Orthopedic Clinic of Isfahan University of Medical Sciences are divided into two Groups. Group 1 received prednisolone tablets (10 mg per day) for one week and treated with Meloxicam, Pantoprazole, Vitamin E for 20 Days. The Group 2 was treated with Placebo, Meloxicam, Pantoprazole, Vitamin E for 20 days, and the clinical symptoms of the patient were compared before intervention and 2 months later.

Inclusion criteria: written informed consent forms, age>18 years, ALSS, and no history of corticosteroid susceptibility. Exclusion criteria: dissatisfaction of the patients to continue the project, severe allergic reaction to oral corticosteroid, have comorbidities (e.g. gastroesophageal reflux disease, dyspepsia, hypertension, renal failure, diabetes mellitus, BMI>30 kilograms per square meter), recent infection within 3 months ago or hospital admission for the same reasons, neuromuscular disease, history of consuming any corticosteroid in the last three months for any kind of disease, history of any surgery on the spine, history of gastrointestinal bleeding, and the need for spinal surgery or additional medications during the study.

The intervention group received an additional oral prednisolone 10 mg each day for one week.The control group received a placebo just like the real prednisolone.

Ability to Walk painlessly Oswestry Disability Index Severity of pain

Revising the RCT protocol for elucidating the process of the study and adding important information and declaring the end of the study

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.

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.