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IRCT20200204046376N1 IRCT 2020-10-28 Esfahan University of Medical Sciences The comparison of Transcutaneous Electrical Nerve Stimulation ( TENS ) and dry needling in subjects with trigger points in upper trapezius muscle The comparison of short-term effects of Transcutaneous Electrical Nerve Stimulation ( TENS ) and dry needling on pain, disability and pressure pain threshold in subjects with trigger points in upper trapezius muscle 2020-10-16 anticipated 45 Complete https://irct.ir/trial/45625 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a table of random numbers, we select 45 numbers and record the numbers in order, then each of the clients is assigned one of these numbers in order. Then the last two digits of the numbers, if it is between ..., the person will be in group A, if it is between ..., the person will be in group B and if it is between ..., the person will be in group C, Blinding description: The person who assesses the outcome before and after the intervention is completely unaware of the grouping of patients and in which group they are in. This person only performs this task during the study And it has no other involvement in the study process. The person analyzing the data is also unaware of which data belongs to the group and will be given the data as group A, B and C data. N/A subjects with trigger points in upper trapezius muscle. Intervention 1: Intervention group1: Group A will receive TENS (Burst type Asymetrical rectangular biphasic pulse electrical current) with 100 Hz frequency and 250 microsecond pulse duration for ten sessions (5 days a week) over two weeks and each session will receive TENS for 20 minutes. The intensity of the electrical current increases to the extent that the patient has a strong sense but no muscle contraction. This current is applied by a channel and two electrodes where the negative electrode is placed on the trigger point of upper trapezius muscle and the positive electrode at the insertion of muscle to the acromion. stimulator710 P Plus (Novin company) will be used for electrical stimulation, in addition, stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Intervention 2: Intervention group:Group B is treated with three sessions of dry needling for two weeks. Before starting the technique, the most sensitive trigger point is detected and Its position on the skin is determined. A needle with a diameter of 0.3 mm and a length of 30 mm, in both prone and supine position on both anterior and posterior sides is insrted after disinfecting the site with alcohol, so that the point is pressed firmly with the thumb and forefinger of the non-dominant hand. In order to obtain a local twitch response, the needle is inserted perpendicular to the muscle tissue for a maximum of 10 times within 10 seconds at a frequency of 1 Hz, also stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Intervention 3: Control group: stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Yes - There is a plan to make this available What will be shared: Demographic information and the main outcome of the study are shared after being unidentifiable When: Access starts after the study has been placed in databases. To whom: Researchers working in academic centers and private centers and other researchers Conditions: Researchers who intend to study systematic review or meta-analysis Where to obtain: Seyyed Mohsen Mirbod (responsible author), via email address How to obtain: The request email and the purpose of requesting the information should be sent to the responsible author, then the responsible author will give them the requested information. Comments:
public Seyyed Mohsen Mirbod
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5000 mirbod@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Seyyed Mohsen Mirbid
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5000 mirbod@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Subjects between 18-50 yrs of age. Subjects who have the ability to read and write. Subject with trigger points in the upper trapezius muscle based on the Travel and Simons diagnistic criteria. Individuals with nonspecific neck pain with a score of at least 3 on the visual analog scale and originating in the trigger points of the upper trapezius muscle, which may also be referred to the area between the scapula and the shoulder. 18 years 50 years Both Fibromyalgia syndrome with specialist physician diagnosis. Postural abnormalities including severe kyphosis or scoliosis where the spine is not in its natural alignment. Congenital deformity in the neck. Taking anticoagulants or using corticosteroids. Use of analgesics within 48 hours before intervention. Alcohol and Drug Use. Cognitive and communication disorders. Sense disorder in the treated area (neck and shoulder area). Symptoms of Radiculopathy. Received treatment for trigger points of the trapezius muscle over the past three months. Degenerative problems of the neck and shoulder joints. History of surgery in the neck or shoulder area. Contraindication to the use of dry needles such as fear of needles and local infection and pregnancy with the risk of miscarriage and menstruation and a serious medical problem. Diagnosis of neurological disorder by a specialist physician. Malignancy and systemic diseases. Treatment - Other Treatment - Other Treatment - Other Intervention group1: Group A will receive TENS (Burst type Asymetrical rectangular biphasic pulse electrical current) with 100 Hz frequency and 250 microsecond pulse duration for ten sessions (5 days a week) over two weeks and each session will receive TENS for 20 minutes. The intensity of the electrical current increases to the extent that the patient has a strong sense but no muscle contraction. This current is applied by a channel and two electrodes where the negative electrode is placed on the trigger point of upper trapezius muscle and the positive electrode at the insertion of muscle to the acromion. stimulator710 P Plus (Novin company) will be used for electrical stimulation, in addition, stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Intervention group:Group B is treated with three sessions of dry needling for two weeks. Before starting the technique, the most sensitive trigger point is detected and Its position on the skin is determined. A needle with a diameter of 0.3 mm and a length of 30 mm, in both prone and supine position on both anterior and posterior sides is insrted after disinfecting the site with alcohol, so that the point is pressed firmly with the thumb and forefinger of the non-dominant hand. In order to obtain a local twitch response, the needle is inserted perpendicular to the muscle tissue for a maximum of 10 times within 10 seconds at a frequency of 1 Hz, also stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Control group: stretching exercise for the trapezius muscle is fully taught to patients, with emphasis on doing the exercises three times a day, each time ten repetition and maintaining a stretching state for 15 seconds. Pain intensity score based on visual analog scale. Timepoint: Pain intensity score will be measured once before the start of the intervention and once after the end of the treatment period ie 2 weeks later. Method of measurement: Visual Analog Scale. Pressure Pain Threshold score. Timepoint: Pressure Pain Threshold score will be measured once before the start of the intervention and once after the end of the treatment period ie 2 weeks later. Method of measurement: Digital Algometer. Neck disability score based on Neck Disability Index Questionnaire. Timepoint: Neck Disability Score will be measured once before the start of the intervention and once after the end of the treatment period ie 2 weeks later. Method of measurement: Neck Disability Index questionnaire. Esfahan University of Medical Sciences Approved 2020-09-23 Ethics Committee of Isfahan University of Medical Sciences Building No. 4, Hezar Jarib St., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)