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IRCT20180507039571N3 IRCT 2025-02-06 Esfahan University of Medical Sciences Investigating the effect of pulsed electromagnetic field on pain intensity and function of patients with spinal stenosis Investigating the effect of pulsed electromagnetic field on pain intensity and function of patients with spinal stenosis compared to the control group referring to physical medicine clinics: A randomized controlled clinical trial study 2025-03-05 anticipated 60 Complete https://irct.ir/trial/81761 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: The allocation of patients to the two intervention and control groups is done randomly by generating a random sequence of numbers by a computer. A researcher other than the principal investigator performs this process. Each patient is assigned a code in the order of their entry into the study, and this code is placed in a sealed envelope and given to the principal investigator, Blinding description: To blind patients, the magnet is set to an intensity of 1 Gauss in the control group so that patients are not aware that the device is on or off. N/A Lumbar Canal Stenosis. Intervention 1: Intervention group: Pulse Electrical Magnetic Stimulation (Novinmed Company with a cylindrical solenoid applicator with a diameter of 70 cm) in the stenotic canal for 10 sessions (25 Hz, 80 Gauss, 15 minutes per day) along with routine treatment (Gabapentin 100 every night, Williams exercise one set of 10 twice a day and Anaheal every 12 hours). Intervention 2: Control group: Pulse Electrical Magnetic Stimulation (Novinmed Company with a cylindrical solenoid applicator with a diameter of 70 cm) in the stenotic canal for 10 sessions (25 Hz, 1 Gauss, 15 minutes per day) along with routine treatment (Gabapentin 100 every night, Williams exercise one set of 10 twice a day and Anaheal every 12 hours). 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 available.
public Shervin Ghaffari Hoseini
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahran Bridge, 3rd Mushtaq St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3611 5208 shghaffari@yahoo.com Esfahan University of Medical Sciences scientific Shervin Ghaffari Hoseini
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahran Bridge, 3rd Mushtaq St., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3611 5208 shghaffari@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Individuals over 50 years of age with a clinical diagnosis of LCS based on the presence of low back pain with intermittent neurological lameness confirmed by LumboSacral MRI The ability to move independently Good mental and cognitive health Consent to participate in the study 50 years no limit Both Back pain for less than 4 weeks Clinical findings inconsistent with the diagnosis of LCS on MRI Having a physiotherapy program in the past 3 months Presence of progressive neurological deficit Infectious Spondylodiscitis such as Tuberculosis, Brucellosis, inflammatory Spondylitis Uncontrolled systemic diseases Liver or renal failure History of back surgery Presence of acute back trauma Lower limb surgery or unhealed fractures Pregnancy Epilepsy Implanted medical devices such as pacemakers, insulin pumps, or hepatic artery infusion pumps M48.06 Spinal stenosis, lumbar region Treatment - Devices Treatment - Devices Intervention group: Pulse Electrical Magnetic Stimulation (Novinmed Company with a cylindrical solenoid applicator with a diameter of 70 cm) in the stenotic canal for 10 sessions (25 Hz, 80 Gauss, 15 minutes per day) along with routine treatment (Gabapentin 100 every night, Williams exercise one set of 10 twice a day and Anaheal every 12 hours) Control group: Pulse Electrical Magnetic Stimulation (Novinmed Company with a cylindrical solenoid applicator with a diameter of 70 cm) in the stenotic canal for 10 sessions (25 Hz, 1 Gauss, 15 minutes per day) along with routine treatment (Gabapentin 100 every night, Williams exercise one set of 10 twice a day and Anaheal every 12 hours) Back pain score on the Visual Analogue Scale questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days and 3 months after the end of treatment. Method of measurement: Using Visual Analogue Scale. Assessing patient performance using the Modified Oswestry questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days and 3 months after the end of treatment. Method of measurement: Using the Modified Oswestry Questionnaire. Esfahan University of Medical Sciences Approved 2025-01-12 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Unit 1, No. 63, Arian Complex, 16th Meghdad Alley, Meghdad Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)