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IRCT20211123053162N1 IRCT 2022-08-31 Shahroud University of Medical Sciences Therapeutic effect of Electro-Acupressure stimulation in knee osteoarthritis Evaluation of therapeutic effect of Electro-Acupressure stimulation in acupuncture points in reducing pain and stiffness and increasing knee joint function in patient with knee osteoarthritis: A randomized clinical trial 2022-09-03 anticipated 126 Complete https://irct.ir/trial/60204 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the samples and assign them to three groups, since the sample size in each group is 42 people, the string of random numbers from 1 to 126, which are classified into three groups, was obtained through the Randomizer.org site and by The methodologist will receive and provide the researcher, Blinding description: The study is of the triple-blind trial, in such a way that the person completing the questionnaire and entering the data into the SPSS software is not aware of the intervention received by the patients. Also, the groups receiving the intervention and the control group are unaware of their placement in the group. For this purpose, in the control group, the electrode of the device touches the skin of the patient's knee in the areas outside the studied points, without any pressure and also without electric current. In this study, the methodologist is also unaware of the group of each patient in the study. N/A Knee osteoarthritis. Intervention 1: intervention group (1): Simultaneous electrical and pressure stimulation. Patients receive both electrical pulse and pressure simultaneously at eight acupuncture points around the knee during 10 sessions of treatment with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week. Intervention 2: Intervention group (2): acupressure stimulation. In 10 sessions of therapy, they only receive pressure at eight points of acupuncture around the knee with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week. Intervention 3: Control group: placebo. In 10 sessions, the tip of the TENS-Pen electrode touch the fake points around the knee. Electrode contact is made in each point for one minute. This operation is performed daily, five days a week for two week. Yes - There is a plan to make this available What will be shared: Demographic data and results related to the main outcome When: If the report is published in open access journal, the access period starts 6 months after the article is published. To whom: For all researchers Conditions: If necessary, contact correspond author and if there is a reasonable justification for use in scientific purposes Where to obtain: Dr. Reza Maskani, Shahroud, 7thTir Square, Shahroud University of Medical Sciences; School of Nursing and Midwifery 02332395054 maskani.r@shmu.ac.ir How to obtain: By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks Comments:
public Mohammad Javad Hashemi
Hafte Tir Square
Shahroud Iran (Islamic Republic of) 3614773943 +98 23 3239 5054 mohammadjavad.hashemi027@gmail.com Shahroud University of Medical Sciences scientific Reza Maskani
Hafte Tir Square
Shahroud Iran (Islamic Republic of) 3614773943 +98 23 3239 5054 maskani.r@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients over 45 years old Patients who have been suffering from osteoarthritis of the knee for at least three months (according to the diagnosis of a rheumatologist). 45 years no limit Both Patients who have had a history of acupuncture points stimulation for any purpose in the past month. Patients who have wound, scratch or abnormality in acupuncture points. Patients who have used anticoagulants in the past month and also patients who have had a history of coagulation diseases in the past month. Patients with a history of knee joint surgery (knee replacement). Patients who have advanced neuropathy (pain, burning, tingling in the toes or feet and extreme sensitivity to surface touch). Patients who are drug abuser. Patients who have had any injection into the knee joint in the past month. Patients who had a knee arthroscopy (a type of knee surgery that diagnoses and treats a knee joint problem) for 30 days prior to the intervention. Patients who have unbearable severe pain in the knee that prevents them from participating in the study. Patients with pacemakers. Patients with transplanted tissue. Pregnant patients. M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Treatment - Devices intervention group (1): Simultaneous electrical and pressure stimulation. Patients receive both electrical pulse and pressure simultaneously at eight acupuncture points around the knee during 10 sessions of treatment with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week. Intervention group (2): acupressure stimulation. In 10 sessions of therapy, they only receive pressure at eight points of acupuncture around the knee with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week. Control group: placebo. In 10 sessions, the tip of the TENS-Pen electrode touch the fake points around the knee. Electrode contact is made in each point for one minute. This operation is performed daily, five days a week for two week. Knee Pain. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: WOMAC and KOOS questionnaire, VAS ruler. Knee joint stiffness. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: WOMAC and KOOS questionnaire. Clinical manifestation of the knee joint. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: WOMAC and KOOS questionnaire. Ability to perform daily tasks. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: WOMAC and KOOS questionnaire. Physical activity. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: KOOS questionnaire. Quality of life. Timepoint: Before the first session, two days after the last session and three weeks after the last session. Method of measurement: KOOS questionnaire. Shahroud University of Medical Sciences Approved 2022-06-13 Research Ethics Committees of Shahroud University of Medical Sciences Hafte Tir Square shahroud Semnan Iran (Islamic Republic of)