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IRCT20230801058995N1 IRCT 2023-10-03 Iran University of Medical Sciences Comparison of ESWT versus acupuncture in treatment of myofascial trigger points in calf muscle Comparison of ESWT versus Dry Needling in treatment of myofascial trigger points in calf muscle 2023-11-22 anticipated 84 Complete https://irct.ir/trial/71719 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into intervention and control groups by randomization method in the form of lottery. In this way, based on the number of samples, half of the lots will receive only shockwave and the other half will receive dry needling. Then, one lot will be drawn for each patient by the person performing it (physical medicine and rehabilitation assistant) who will be constant and not the evaluator of the research. And the intended intervention is implemented for the patient, Blinding description: The method of blinding for the analyzer is that the selected intervention for each patient is written in the demographic questionnaire using a lottery by the person performing it, and the analyzer is written on the way of grouping and the type of treatment selected for the patients until the end of the 6-month evaluation. will not be aware. 2-3 Myofascial trigger point. Intervention 1: The first intervention group is subjected to shockwave therapy, which is provided once a week for three consecutive weeks. Shockwave therapy using Storz medical masterpulse MP100 device is applied in each session with settings: intensity 1.5 to 3 times, 1000 impulses in the trigger point area and 500 impulses around and 10 Hz frequency and for 3-4 minutes. Intervention 2: In the dry needling group, the treatment will be done with disposable dong-bang stainless steel needles in sizes 0.25 x 0.4 after sterilizing the needle insertion site in painful points with alcohol cotton. The needles are inserted through the guide tube in the specified painful points, and the depth of the needles is 15-30 mm, and they remain in place for 20 minutes in each session, and at the 10th minute, the needles are rotated for re-stimulation. Yes - There is a plan to make this available What will be shared: The rate of improvement of the patient's pain can be shared based on the Visual Analogue Scale and pain pressure threshold When: Access starts from 1404 To whom: Study data will be available only to researchers working in academic and scientific institutions. Conditions: Access to the data for epidemiological investigation and study will be allowed and can be sent via email. Where to obtain: To get the data, you can call 00989183769745 via mobile phone or contact via email rezashokri70@gmail.com. How to obtain: People applying for data should send their academic and scientific documents and the reason for their request to rezashokri70@gmail.com. Comments:
public Tannaz Ahadi
Vali Asr Square, Karim Khan Zand St., Beh Afrin St., Firouzgar Hospital
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۸۷۱۱ +98 21 8214 1000 tannaz.ahadi@yaho.com Iran University of Medical Sciences scientific Tanaz.Ahadi
Vali Asr Square, Karim Khan Zand St., Beh Afrin St., Firouzgar Hospital
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۸۷۱۱ +98 21 8214 1000 tannaz.ahadi@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Age between 16 and 60 years Patient satisfaction Having at least one active trigger point in the cuff area Duration of symptoms for at least 6 months 16 years 60 years Both Presence of neurological defects (weakness, paresthesia, etc.) History of lumbar discopathy, lumbar disc herniation, myopathy, fibromyalgia, spondylosis, spinal canal stenosis Current drug treatments or physical therapy, surgery and injection in trigger point in the last 6 months Simultaneous painful disorders so that the main complaint of the patient is simultaneous pain Mental disorder Rheumatological diseases M79.1 Myalgia Treatment - Devices Treatment - Devices The first intervention group is subjected to shockwave therapy, which is provided once a week for three consecutive weeks. Shockwave therapy using Storz medical masterpulse MP100 device is applied in each session with settings: intensity 1.5 to 3 times, 1000 impulses in the trigger point area and 500 impulses around and 10 Hz frequency and for 3-4 minutes. In the dry needling group, the treatment will be done with disposable dong-bang stainless steel needles in sizes 0.25 x 0.4 after sterilizing the needle insertion site in painful points with alcohol cotton. The needles are inserted through the guide tube in the specified painful points, and the depth of the needles is 15-30 mm, and they remain in place for 20 minutes in each session, and at the 10th minute, the needles are rotated for re-stimulation. Pain variable is evaluated by two scales.PPT is calculated by using a digital algometer by applying vertical pressure to the trigger points. In order to stimulate the patient's pain, the pressure is increased at a rate of 1Kg/Cm2/s and the subjective reports of the people are recorded. The place of maximum pain is at a distance of 1 minute will be checked again.Visual analog scale (VAS) measures the intensity of the patient's pain. Validation and reliability studies have been done. The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain).n of general health, vitality, social role function, limitation in emotional function and health. It is fluent. The checklist is attached.Visual analog scale (VAS) measures the intensity of the patient's pain. Validation and reliability studies have been done. The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain). Timepoint: VAS and PPT variables are completed for each patient immediately after completing three sessions of shock wave and dry needling, and then one month and three months after the completion of the interventions. Also, the VAS variable is checked again six months after the end of the interventions. Method of measurement: PPT is calculated using a digital algometer (Brandwagner) by applying vertical pressure to the trigger points. In order to stimulate the patient's pain, the pressure is increased at a rate of 1 Kg/Cm2/s and the subjective reports of the people are recorded.The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain). The quality of life is measured by the 36-item short form (SF-36), which is the most widely used general quality of life scale in the medical field. It includes 8 sub-categories, which are 36 items in total, and evaluates physical and mental health in general. The sub-categories include physical function, difficulty in performing physical activity, pain, perceptio. Timepoint: It is completed immediately after three sessions of shock wave and dry needling, and then one month and three months after the completion of the interventions for each patient. Method of measurement: In this study, the quality of life is calculated by the SF-36 questionnaire. Iran University of Medical Sciences Approved 2022-09-28 Ethics Committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower، 14535 Tehran Tehran Iran (Islamic Republic of)