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IRCT20220626055278N1 IRCT 2022-07-19 Zahedan University of Medical Sciences The Effect of high-intensity laser on pain and disability in women with neck pain The Effect of High-intensity laser on pain, disability and upper trapezius muscle activity in women with cervical myofascial pain syndrome 2022-07-05 anticipated 40 Complete https://irct.ir/trial/64413 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization will be done based on the quadruple permutation blocks method. All possible blocks are arranged as follows: 1:ABAB 2:AABB 3: ABBA 4: BBAA 5:BABA 6: BAAB We need 10 blocks to select 40 people. We randomly select these blocks from numbers 1 to 6. Using R soft ware, we choose a random number between numbers 1 to 6. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB respectively. Finally, group A: control and group B: intervention, Blinding description: Patients will be unaware of the grouping.Physiotherapy modalities are explained to the patients and they are told that one or more modalities are used in their treatment, but they will be unaware of what modalities are used in each group. N/A Myofascial pain syndrom. Intervention 1: Intervention group: It will include high-intensity laser and conventional physiotherapy(trans cutaneous electrical nerve stimulation, ultrasonic waves and ischemic pressure). High-intensity laser with wavelengths of 660, 800, 905, 970 nano meter and maximum power of 20 watts is made in Italy. The time of laser treatment will be five minutes and eight seconds. The total energy received by the tissue is 2957 joules, which will be applied by the physiotherapist on the upper trapezius muscle of the patient in the prone position. In this group, trans cutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes will be applied through two electrodes that we are placing on the upper trapezius muscle of the patient. Ultrasonic waves with frequency of 1 Mega Hertz and intensity of 1.5 watts per square centimeter and continuous current will be applied to the upper trapezius muscle for 5 minutes. Ischemic pressure will be applied 4 times, each time for 90 seconds with uniform pressure by the physiotherapist's thumb on the trigger points of the upper trapezius muscle. Trans cutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. The intervention will consist of twelve sessions, during four weeks, three times each week. Intervention 2: Control group: conventional physiotherapy will include trans cutaneous electrical nerve stimulation, ultrasonic waves and ischemic pressure. Trans cutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes, will be applied through two electrodes that we are placing on the upper trapezius muscle of the patient. Ultrasonic waves with frequency of 1 Mega Hertz and intensity of 1.5 watts per square centimeter and continuous current will be applied to the upper trapezius muscle for 5 minutes. Ischemic pressure will be applied 4 times, each time for 90 seconds with uniform pressure by the physiotherapist's thumb on the trigger points of the upper trapezius muscle. Trans cutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. The intervention will consist of twelve sessions, during four weeks, three times each week. 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 No more information
public Maryam Sargolzehi
No.35 , East Azadegan St., Corner of Farhad St
Zahedan Iran (Islamic Republic of) 9817687643 +98 54 3321 7006 Sargolzaei_pt@yahoo.com Zahedan University of Medical Sciences scientific Hassan Namvar
Modares St., next to medical imaging, Namvaran Doctors Building, Atieh Physiotherapy
Zahedan Iran (Islamic Republic of) 9816677389 +98 54 3344 6819 hassan_753@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) women aged 18 to 55 years Primary complaint of neck pain with shoulder girdle symptoms Percentage of neck disability index between 10 and 40 Visual analogue scale greater than or equal to 3 Existence of active trigger point in the upper trapezius muscle Having five major criteria and at least one of three minor criteria based on Simon diagnostic method for clinical diagnosis of myofacial neck pain syndrome Not having cervical spine surgery, canal stenosis at level of the cervical vertebrae, neck radicular pain, fibromyalgia 18 years 55 years Female Failure to complete treatment sessions Exacerbation of symptoms or patient dissatisfaction with the continuation of treatment sessions Rehabilitation Rehabilitation Intervention group: It will include high-intensity laser and conventional physiotherapy(trans cutaneous electrical nerve stimulation, ultrasonic waves and ischemic pressure). High-intensity laser with wavelengths of 660, 800, 905, 970 nano meter and maximum power of 20 watts is made in Italy. The time of laser treatment will be five minutes and eight seconds. The total energy received by the tissue is 2957 joules, which will be applied by the physiotherapist on the upper trapezius muscle of the patient in the prone position. In this group, trans cutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes will be applied through two electrodes that we are placing on the upper trapezius muscle of the patient. Ultrasonic waves with frequency of 1 Mega Hertz and intensity of 1.5 watts per square centimeter and continuous current will be applied to the upper trapezius muscle for 5 minutes. Ischemic pressure will be applied 4 times, each time for 90 seconds with uniform pressure by the physiotherapist's thumb on the trigger points of the upper trapezius muscle. Trans cutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. The intervention will consist of twelve sessions, during four weeks, three times each week. Control group: conventional physiotherapy will include trans cutaneous electrical nerve stimulation, ultrasonic waves and ischemic pressure. Trans cutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes, will be applied through two electrodes that we are placing on the upper trapezius muscle of the patient. Ultrasonic waves with frequency of 1 Mega Hertz and intensity of 1.5 watts per square centimeter and continuous current will be applied to the upper trapezius muscle for 5 minutes. Ischemic pressure will be applied 4 times, each time for 90 seconds with uniform pressure by the physiotherapist's thumb on the trigger points of the upper trapezius muscle. Trans cutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. The intervention will consist of twelve sessions, during four weeks, three times each week. Pain that is more than 3 or 3 befor intervention, decreases after the intervention. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Visual analoge Scale. Disability, befor the intervention, its percentage is between 10 and 40 and decreases after the intervention. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Neck Disability Index Questionnaire. Increased muscle activity that decreases after the intervention. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Surface Electromyography Device. Zahedan University of Medical Sciences Approved 2022-06-25 Ethics committee of Zahedan University of Medical Sciences Dr. Hesabi Square, Imam Hossein Blvd, compus of university of medical sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)