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IRCT20240115060701N1 IRCT 2024-01-23 Shahid Beheshti University of Medical Sciences Evaluation of the effect of high-intensity laser therapy compared to low-intensity laser therapy in improving the symptoms of lumbosacral disc herniation patients with radiculopathy Evaluation of the effect of high-intensity laser therapy compared to low-intensity laser therapy in improving the symptoms of lumbosacral disc herniation patients with radiculopathy 2024-02-20 anticipated 50 Complete https://irct.ir/trial/75004 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, according to the design, the patient is subjected to standard treatment, only the patient is not informed whether the treatment is high-power or low-power laser to reduce bias. N/A Low Back Pain. Intervention 1: Intervention group: 25 patients with low back pain who will be treated with 10 session of High Intesity Laser Therapy, 5 session per week with a frequency of 25 Hz, power of 10 watts, with a dose of 12 j/cm2 in the lumbar region for 4 minutes in biostimulation mode, followed by continuous mode for 6 minutes with a power of 7 watts and a dose of 10 j/cm2. Intervention 2: Intervention group: 25 patients with low back pain who will be treated with 10 session of Low Intesity Laser Therapy, 5 session per week, GaAlAs infrared radiation, wavelength 808 nm, power 160 mV and penetration depth 4 cm. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people When: The access period starts one year after the results are published. To whom: Data of this study will be available to researchers working in academic and scientific institutions. Conditions: In the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of patients will be provided to the researchers. Where to obtain: By Sending an email to jabbarmozaffari@sbmu.ac.ir How to obtain: Sending an email requesting information and explaining the purpose and how to use the data Comments:
public Abdoljabbar Mozaffari Komsh Tappeh
Shohada Tajrish Hospital, Shahrdari Street, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2273 1112 jabbarmozaffari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Darioush Eliaspour
Shohada Tajrish Hospital, Shahrdari Street, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 9634 d.eliaspour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients who attend the physical medicine and rehabilitation clinic with low back pain 30 years 75 years Both History of spinal fracture or surgery History of epidural steroid injection within 4 weeks before Presence of Malignancy Pregnancy Having a cardiac pacemaker M54.5 Low back pain Treatment - Devices Treatment - Devices Intervention group: 25 patients with low back pain who will be treated with 10 session of High Intesity Laser Therapy, 5 session per week with a frequency of 25 Hz, power of 10 watts, with a dose of 12 j/cm2 in the lumbar region for 4 minutes in biostimulation mode, followed by continuous mode for 6 minutes with a power of 7 watts and a dose of 10 j/cm2 Intervention group: 25 patients with low back pain who will be treated with 10 session of Low Intesity Laser Therapy, 5 session per week, GaAlAs infrared radiation, wavelength 808 nm, power 160 mV and penetration depth 4 cm Low Back Pain. Timepoint: At the beginnigng of the study ( before the start of the treatment) and 1 months after treatment. Method of measurement: Visual Analogue Scale ( VAS ). Degree of disability. Timepoint: At the beginnigng of the study ( before the start of the treatment) and 1 months after treatment. Method of measurement: Oswestry Disability Index (ODI). Shahid Beheshti University of Medical Sciences Approved 2023-07-01 Research Ethics committees of Shahid Beheshti University of Medical Sciences and Healthcare Services Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yaman Street, Shahid chamran Highway, Tehran Tehran Iran (Islamic Republic of)