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IRCT20230814059144N1 IRCT 2023-08-20 Medical Equipment Avin Teb effect of TENS on menstrual pain Evaluation clinical effectiveness of the TENS device in reducing menstrual pain 2023-08-26 anticipated 74 Complete https://irct.ir/trial/72096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the number of participants in the study plus 20%, code 1 and 2 will be considered. Code 1 will be for the control group and code 2 will be for the test group. Then the codes are written on small pieces of paper and the paper is folded. The folded papers are put into a container and one is randomly picked, Blinding description: The inclusion and exclusion criteria of the study are evaluated by a physiotherapist unaware of the research method and based on clinical tests. Since the names of the groups are written as codes 1 and 2 and the device is used as a placebo (no output) for the control group, the patients are blinded. 4 menstrual pain. Intervention 1: The intervention of one session will be done on the day of menstruation when the participant has the most pain. The pulse width and frequency of the output current are equal to 100 microseconds and 100 Hz, respectively. The size of the electrode area is 45 mm. The time to use the device will be 30 minutes. Participants lie on their side. If you feel pain in the lower abdomen, the self-adhesive electrode will be attached below the level of the navel on the clean and dry skin of the abdomen, and if you feel pain in the lower back, the electrode will be attached to the clean and dry skin of the lower back. To use the skin device, first the electrodes are attached to the skin and after making sure that the device is off, it is connected to the device by means of a connecting wire. Then the device is turned on and the intensity of the current increases to below the pain threshold. After the end of the usage time, the device is turned off and the electrodes are separated from the skin. Intervention 2: Control group: The procedure will be similar to the experimental group, but the device has no output. No - There is not a plan to make this available Justification or reason for not sharing IPD is The present study is carried out to confirm the effectiveness of the TENS device at the request of the industry, and its results will be reported to Avin Teb Medical Engineering Company in order to obtain the necessary license for mass production.
public Ashraf Mahmoudzadeh
Nika Building, Azadegan Alley, Khosropur St, Hazar Jarib St, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5229 amahmoudzadeh58@gmail.com Esfahan University of Medical Sciences scientific Ashraf Mahmoudzadeh
Nika Building, Azadegan Alley, Khosropur St, Hazar Jarib St, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5229 amahmoudzadeh58@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Women 18-45 years old History of pain during at least the last 3 cycles moderate to severe pain (VAS ≤ 5) that was needed to take painkillers to relieve the pain. 18 years 45 years Female History of lower abdominal surgery Scars, wounds, abdominal skin sensitivity Suffering from cancer, diabetes, heart, immunity, epilepsy and psychological diseases Suffering from other women's diseases such as poly-cystic ovaries, endometriosis and uterine fibroid Using a pacemaker N94 Pain and other conditions associated with female genital organs and menstrual cycle Rehabilitation Rehabilitation The intervention of one session will be done on the day of menstruation when the participant has the most pain. The pulse width and frequency of the output current are equal to 100 microseconds and 100 Hz, respectively. The size of the electrode area is 45 mm. The time to use the device will be 30 minutes. Participants lie on their side. If you feel pain in the lower abdomen, the self-adhesive electrode will be attached below the level of the navel on the clean and dry skin of the abdomen, and if you feel pain in the lower back, the electrode will be attached to the clean and dry skin of the lower back. To use the skin device, first the electrodes are attached to the skin and after making sure that the device is off, it is connected to the device by means of a connecting wire. Then the device is turned on and the intensity of the current increases to below the pain threshold. After the end of the usage time, the device is turned off and the electrodes are separated from the skin. Control group: The procedure will be similar to the experimental group, but the device has no output Pain. Timepoint: before, immediately, one hour and 24 hours after the intervention. Method of measurement: visual analog scale. Medical Equipment Avin Teb Approved 2023-07-17 Ethic committee of Isfahan university of medical sciences Isfahan University of Medical Sciences,Isfahan Isfahan Isfehan Iran (Islamic Republic of)