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IRCT20200423047173N2 IRCT 2023-06-16 Artesh University of Medical Sciences Investigating the effect of electrical stimulation of the lower back in preventing back pain. Development of a protocol for the prevention of back pain based on the use of electrical stimulation of the lumbar region. 2023-06-22 anticipated 100 Complete https://irct.ir/trial/70379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The participants, including individuals without back pain, were randomly divided into two groups using the coin flip technique. The first group received TENS current applied to the lower back, while the second group served as the control group and received sham TENS current. This protocol was conducted for a duration of two weeks, with each participant receiving ten sessions of TENS current in the lower back, Blinding description: In the current study, the clinical caregiver responsible for the patients and the individual conducting the clinical tests and interventions on the participants will be blinded to the study objectives. Additionally, the data analysis before and after the interventions will be performed by an independent person who is unaware of the study conditions. N/A Low back pain. Intervention 1: In the intervention group, participants will receive conventional TENS current with a frequency of 100 Hz, a pulse duration of 50 microseconds, and an intensity up to the tolerance threshold for a duration of 45 minutes. Intervention 2: In the control group, participants will receive conventional TENS current with a frequency of 100 Hz, a pulse duration of 50 microseconds, and an intensity up to the tolerance threshold for a duration of 45 minutes. However, the intensity used in the control group will be significantly lower than the tolerance threshold. 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 Dr Hassan Tamartash
Shahid Etemadzadeh Street, West Fatemi Street, Tehran, Iran
tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 mojtaba.tamartash@gmail.com Artesh University of Medical Sciences scientific Dr Hassan Tamartash
Shahid Etemadzadeh Street, West Fatemi Street, Tehran, Iran
tehran Iran (Islamic Republic of) 1411718541 +98 21 4432 2852 mojtaba.tamartash@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) No history of back pain in the last 12 months The minimum age to enter the study is 20 and the maximum is 50 years. BMI index between 18-30.5 for all participants in the study. 20 years 50 years Both History of spine and lower limb surgery. The presence of pastural disorders and major deformities in the spine such as scoliosis, kyphosis, etc. Suffering and history of rheumatic diseases, infectious diseases, cardiovascular disorders, fibromyalgia, osteoporosis. History of fracture in the spine or tumors of the spine and lower limbs. Disorders of vestibular, vision and mental system. Use of corticosteroid drugs and history of injections in the lower back area (oral administration or injection of steroids). Carrying out intense physical activity during the study period, inability to perform tests, or unwillingness to continue tests. M54.40 Lumbago with sciatica, unspecified side Prevention Placebo In the intervention group, participants will receive conventional TENS current with a frequency of 100 Hz, a pulse duration of 50 microseconds, and an intensity up to the tolerance threshold for a duration of 45 minutes. In the control group, participants will receive conventional TENS current with a frequency of 100 Hz, a pulse duration of 50 microseconds, and an intensity up to the tolerance threshold for a duration of 45 minutes. However, the intensity used in the control group will be significantly lower than the tolerance threshold. Changes in the thickness of the lumbar fascia. Timepoint: Before the start of the intervention, after the completion of the intervention sessions, two weeks after the end of the study. Method of measurement: Ultrasound device. Changes in the angle of the back arch. Timepoint: Before the start of the intervention, after the completion of the intervention sessions, two weeks after the end of the study. Method of measurement: Spinal mouse. Maximum back bending angle. Timepoint: Before the start of the intervention, after the completion of the intervention sessions, two weeks after the end of the study. Method of measurement: Flexible Ruler. Checking the flexibility of the waist area. Timepoint: Before the start of the intervention, after the completion of the intervention sessions, two weeks after the end of the study. Method of measurement: Sit & reach test. Artesh University of Medical Sciences Approved 2023-05-15 Research ethics Committee of AJA University of Medical Sciences Shahid Etemadzadeh Street, West Fatemi Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)