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IRCT20170616034567N2 IRCT 2020-09-11 Shahid Beheshti University of Medical Sciences Investigation of the effects of intramuscular electrical stimulation on trigger points A Comparative Study of Sonographic and Clinical Parameters of Trigger Point of the Upper Fiber of the Trapezius Muscle Following " Dry Needling " and " Intramuscular Electrical Stimulation " (IMES) through Needle. 2020-09-05 anticipated 30 Complete https://irct.ir/trial/50518 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: balanced block randomization Allocation concealment: sealed envelope How to do randomization: To randomize by balanced block randomization method, we do the following: Intervention group code: A Control group code: B 1. Due to having two groups, the designated blocks are four (AABB). The group codes in these blocks can be designed in six ways. 1(AABB), 2(BBAA), 3(ABAB), 4(BABA), 5(ABBA), 6(BAAB) ۲. Depending on the size of the sample of thirty, 8 of these blocks, which are 32 codes in total, are randomly placed next to each other. 3. Then, each of these codes, which represents the treatment group of each patient, is placed in a sealed envelope, and these envelopes are placed next to each other. These steps will be performed by another person and the lead researcher does not know each person's group until the moment of intervention, Blinding description: In this study, the data analyzer is blinded because they do not known each patient belongs to which intervention group. To do this, the names of the groups are coded (intervention group: A and control group: B) and data analyzer will not know the code of each group. N/A Upper trapezius muscle trigger point. Intervention 1: Intervention group: intramuscular electrical stimulation, The intervention in this group was intramuscular electrical stimulation in which the patient was placed lying on his stomach. The muscle is then touched and the needle is inserted into the trigger point and the therapist's fingers. In the next step, the cathode electrode is connected to the needle and the other pole is placed on the spinous process of the seventh vertebra of the neck by a circular electrode. This will apply the current to the trigger point for 10 minutes. At the end of the mentioned period, first the current intensity is zero and then the device is removed from the patient's body and the needle is removed. Intervention 2: Control group: Dry Needling Group, In this group of patients, needling will be performed for the patient as in the previous group. In this way, after the needle enters the trigger point, the needle will move in and out. This process will continue until the insertion and removal of the twitch needle is no longer seen at the trigger point 10 times, then the needle will leave the individual muscle. 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 A decision will be made after the implementation of the study.
public Monavar Hadizadeh
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Ave
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 8496 Hadizadeh.mahsa1992@yahoo.com Shahid Beheshti University of Medical Sciences scientific Abbas Rahimi
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Ave
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 8496 arahimiuk@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Active trigger points in the upper trapezius muscle Pain associated with the upper trapezius muscle trigger point above 3 based on the VAS scale which is considered as moderate pain. Age: 18-35 years. 18 years 35 years Both Perform injections or other treatments for trigger points in the period of one month before the research. Previous history of muscle diseases such as fibromyalgia and myopathy. Malignancy or patients prone to infection. Central and peripheral neurological disorders. Skin damage in the trigger point area. Taking sedatives before and during treatment. Radicular pain and history of neck and shoulder surgery. Previous history of bad response to acupuncture or dry needling. Pregnancy. Taking anticoagulants. Significant fear of dry needling. Vascular disease. Diabetes. History of migraine. History of accident or trauma in the relevant areas. Treatment - Other Treatment - Other Intervention group: intramuscular electrical stimulation, The intervention in this group was intramuscular electrical stimulation in which the patient was placed lying on his stomach. The muscle is then touched and the needle is inserted into the trigger point and the therapist's fingers. In the next step, the cathode electrode is connected to the needle and the other pole is placed on the spinous process of the seventh vertebra of the neck by a circular electrode. This will apply the current to the trigger point for 10 minutes. At the end of the mentioned period, first the current intensity is zero and then the device is removed from the patient's body and the needle is removed. Control group: Dry Needling Group, In this group of patients, needling will be performed for the patient as in the previous group. In this way, after the needle enters the trigger point, the needle will move in and out. This process will continue until the insertion and removal of the twitch needle is no longer seen at the trigger point 10 times, then the needle will leave the individual muscle. Pain. Timepoint: Before, after and one month after treatment. Method of measurement: by Visual Analogue Scale. Pain pressure threshold. Timepoint: Before, after and one month after treatment. Method of measurement: by algometer. Neck range of motion. Timepoint: Before, after and one month after treatment. Method of measurement: lateral flexion and rotation by goniometer. Disability. Timepoint: Before, after and one month after treatment. Method of measurement: by Neck Disability Index. Ultrasonic parameters. Timepoint: Before, after and one month after treatment. Method of measurement: by sonography device. Shahid Beheshti University of Medical Sciences Approved 2020-08-09 Ethics Committee in Biomedical Research, Shahid Beheshti University of Medical Sciences No. 2, Shahid Beheshti University of Medical Sciences, Evin Ave, Tehran Tehran Tehran Iran (Islamic Republic of)