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IRCT20190925044884N1 IRCT 2019-12-24 Kermanshah University of Medical Sciences Comparison of the Effect of Transcutaneous Electrical Acupoint Stimulation and Infrared on the Severity of the restless leg Syndrome Comparison of the Effect of Transcutaneous Electrical Acupoint Stimulation and Infrared on the Severity of the restless leg Syndrome 2019-10-23 anticipated 60 Complete https://irct.ir/trial/42556 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, a simple randomization method will be used. The random number table will be used to select the samples and place them in the intervention and control modes, Blinding description: Participants in this study will not know which of the intervention and control groups they belong to. The data analyzer also does not know which data belongs to which group. N/A Restless leg syndrome. Intervention 1: Intervention group: Transcutaneous Electrical Acupoint Stimulation.In the electrical stimulation intervention group, skin stimulation was performed with AcuHealth (Australian Made) at specified locations.Electrical stimulation of the specimens was performed for each sample for 4 consecutive weeks, 3 times a week, and every 5 minutes. Intervention 2: Intervention group: Infrared.In the infrared intervention group, infrared light therapy sessions are conducted in two sessions, with each individual in the intervention group being treated three times a week for one month. The BioBeam940 (Israel-made) portable, FDA-approved, portable, hand-held device is used to conduct infrared light therapy sessions. In this regard, the 2 nm wavelength in the NIR range, with a power of 1 mW / cm2, a frequency of 2 Hz, a maximum focusing power of 2 mW, and a 2 degree radiation angle are applied to each acupuncture point of each foot as well as the entire plantar surface of each. The foot will be exposed to infrared light It should be noted that the energy transfer to each acupuncture point is two minutes in order to transmit energy to the foot from the method used in the bath so that the infrared probe in The whole plantar surface will move about for 5 minutes, so each person will have to walk 5 minutes in total. Session receives infrared light. Intervention 3: Control group: Intervention group: Transcutaneous Electrical Acupoint Stimulation.While the sessions in the control group will be administered in the form of dummy treatment, the researcher only pretends that he is undergoing electrical stimulation therapy in the control group, but in fact, the acupuncture points of these individuals are not stimulated. 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 After obtaining permission from the samples will be decided.
public Mohammad Nazarian Pirdosti
Farabi Hospital, Dollat Abad, Kermanshah, Iran
kermanshah Iran (Islamic Republic of) 6715847141 +98 83 4512 6851 mnazarianpirdosti@gmail.com Kermanshah University of Medical Sciences scientific Behnam Khaledi Paveh
Farabi Hospital, Dollat Abad, Kermanshah, Iran
kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3816 2401 bkhaledipaveh@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent to participate in the study Having restless legs syndrome Age range between 18 and 65 years Not being cancer Not receiving pharmacological and non-pharmacological treatment to relieve restless leg syndrome Not having pacemaker 18 years 65 years Both Failure to attend more than 3 sessions Using Restless Foot Syndrome Soothing Medications Migration Death G25.81 Restless legs syndrome Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: Transcutaneous Electrical Acupoint Stimulation.In the electrical stimulation intervention group, skin stimulation was performed with AcuHealth (Australian Made) at specified locations.Electrical stimulation of the specimens was performed for each sample for 4 consecutive weeks, 3 times a week, and every 5 minutes. Intervention group: Infrared.In the infrared intervention group, infrared light therapy sessions are conducted in two sessions, with each individual in the intervention group being treated three times a week for one month. The BioBeam940 (Israel-made) portable, FDA-approved, portable, hand-held device is used to conduct infrared light therapy sessions. In this regard, the 2 nm wavelength in the NIR range, with a power of 1 mW / cm2, a frequency of 2 Hz, a maximum focusing power of 2 mW, and a 2 degree radiation angle are applied to each acupuncture point of each foot as well as the entire plantar surface of each. The foot will be exposed to infrared light It should be noted that the energy transfer to each acupuncture point is two minutes in order to transmit energy to the foot from the method used in the bath so that the infrared probe in The whole plantar surface will move about for 5 minutes, so each person will have to walk 5 minutes in total. Session receives infrared light. Control group: Intervention group: Transcutaneous Electrical Acupoint Stimulation.While the sessions in the control group will be administered in the form of dummy treatment, the researcher only pretends that he is undergoing electrical stimulation therapy in the control group, but in fact, the acupuncture points of these individuals are not stimulated. In this study, we compared the effect of acupuncture points and infrared light on the severity of restless legs syndrome using the restless legs syndrome universal questionnaire whose score is below 4. Timepoint: In this study, we compared the efficacy of acupuncture points and infrared light on the severity of restless leg syndrome, the first measurement with a pre-test and the second with a post-test, and the third measurement to determine whether the method was effective. Whether or not treatment will continue, one month after the end of treatment, re-treatment will be perform. Method of measurement: Restless Foot Syndrome World Questionnaire. Kermanshah University of Medical Sciences Approved 2019-09-17 Ethics committee of Kermanshah University of Medical Sciences Branch of researchs and industry,Kermanshah University Of Medical Sciences, Shahid Beheshti Blvd, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)