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IRCT20210706051807N1 IRCT 2022-03-29 Iran University of Medical Sciences Effect of dry needling on pain and active craniocervical range of motion in patients with tension-type headache. comparison between dry needling for suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis and cervicis, frontalis and temporalis muscles and sham dry needling on pain and active craniocervical range of motion in people with episodic tension-type headache 2021-11-22 anticipated 42 Complete https://irct.ir/trial/58136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized to an experimental group (dry needling and standard physical therapy) or a control group (sham dry needling and standard physical therapy) using the block balanced randomization with an allocation ratio of 1:1. The random allocation sequence will be created by a researcher not involved in the assessments or interventions. The random allocation method consists of four-letter blocks made of 2 letters; A and B (A letter shows dry needling and standard physical therapy and letter B indicates sham dry needling and standard physical therapy). Then, randomization letters will be placed in sequentially numbered opaque sealed envelopes. The treatment will be performed according to the letter in each envelope, Blinding description: Two people will do assessment and treatment; the assessor will be blind to the allocation concealment, and participants will be blind to the actual treatment or control group. Both the treatment group and the control group receive primary treatment, including exercise and knowledge of the nature and management of the disease. The only difference between the two groups is the application of the needle subcutaneously in a location farther away from the marked points. The patient in the control group is placed in a real dry hand, and the same type of needle is used. N/A Episodic tension type headache. Intervention 1: Intervention group: Dry needling treatment is performed by a physiotherapist who has been trained in this field and has three years of experience working with patients with musculoskeletal problems. In this study, a needle with a length of 3 cm and a diameter of 0.25, Tony model will be used. To perform a dry needling for the Temporalis, Frontalis and Masseter muscles, the patient is placed in a supine position, and after detecting the trigger points of the muscles by flat palpation with the non-dominant hand, the needle will enter the muscles perpendicular to the skin by the dominant hand. The needle will be moved inside these muscles by flexion and extension movements of the wrist by pistoning method. To perform a dry needling in the upper trapezius muscle, the patient sleeps prone. In this position, the therapist finds the active trigger points of this muscle by pincer palpation with the non-dominant hand, and then the therapist inserts the needle into the muscle with his dominant hand and moves the needle towards the fingers of his non-dominant hand. In this position, with flexion and extension movements of wrist, the therapist moves the needle into the muscle. Side position is used for Dry needling in Levator scapula and Splenius cervicis and capitis muscles. In this situation, the therapist finds the trigger points of these muscles by pincer palpation with the non-dominant hand and then inserts the needle into these muscles with the help of the dominant hand. For the upper part of the Levator scapula muscle, the needle enters the muscle perpendicular to the skin, and for the lower part of this muscle, the needle enters the muscle in the outward and distal direction, towards the upper angle of the scapula. For the splenius capitis muscle, the needle enters inward and distally toward the fingers of non-dominant hand. For the cervical splenius muscle, the needle will be inserted perpendicular to the skin in a backward-forward direction. For sub occipital muscle dry needling in the prone position, the therapist inserts the needle perpendicular into the skin between the transverse process of the atlas vertebra and the spinous process of the second cervical vertebra. The direction of the needle is towards the eye on the opposite side. The treatment is continued until it is no longer LTR taken from the muscles. After taking the last LTR, the needle stays in place for 20 minutes, and after removing the needle, the exit point of the needle will be compressed for 60 seconds. Treatment will take six sessions, two weeks and three sessions a week. As a basic treatment, patients will receive exercises to improve posture and education to be aware of the nature of the disease and how to manage it. Intervention 2: Control group: For Sham dry needling, the patient is placed in the position of a real dry needling and the same type of needle is used. The difference is that the needle is applied subcutaneously in a place farther from the marked points and After 20 minutes, remove the needle from the tissue and squeeze the area for 60 seconds. Treatment will take six sessions, two weeks and three sessions a week. As a basic treatment, patients will receive exercises to improve posture and education to be aware of the nature of the disease and how to manage it. Yes - There is a plan to make this available What will be shared: Individual Participant Data: all collected deidentified IPD When: starting 6 months after publication To whom: people working in academic institutions Conditions: using for Supplementary study Where to obtain: e-mail address : gandomidokht.a@iums.ac.ir How to obtain: name, address, position, title of study and protocol of study Comments:
public Alireza Gandomi Dokht
No.19, Rabiei hashemi alley, Ahmadisakha street, Qazvin avenue, Gomrok town
Tehran Iran (Islamic Republic of) 1337899484 +98 21 5540 1160 gandomidokht.a@iums.ac.ir Iran University of Medical Sciences scientific Alireza Gandomi Dokht
No.19, Rabiei hashemi alley, Ahmadisakha street, Qazvin avenue, Gomrok town
Tehran Iran (Islamic Republic of) 1337899484 +98 21 5540 1160 gandomidokht.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Men and women between 20 and 50 years age Having a diagnosis of CTTH based on the International Classification of Headache Disorders, 3rd edition Having at least one active trigger point in each of the muscles of the sub occipital, sternocleidomastoid, upper trapezius, temporalis, levator scapula, masseter, frontalis and splenius cervicis and capitis Moderate pain intensity from 30 to 60 based on visual Analog scale 20 years 50 years Both Fear of needles Any change in the dose or type of medication taken Absence of two consecutive sessions or more History of surgery in head, neck, and shoulder Pregnant woman and woman with infant People with cancer, infectious diseases or systemic diseases History of involvement with other types of primary headaches History of neck radiculopathy and other orthopedic neck injuries (including fractures, facet joint syndrome, etc.) in the past year. G44.21 Episodic tension-type headache Treatment - Other Placebo Intervention group: Dry needling treatment is performed by a physiotherapist who has been trained in this field and has three years of experience working with patients with musculoskeletal problems. In this study, a needle with a length of 3 cm and a diameter of 0.25, Tony model will be used. To perform a dry needling for the Temporalis, Frontalis and Masseter muscles, the patient is placed in a supine position, and after detecting the trigger points of the muscles by flat palpation with the non-dominant hand, the needle will enter the muscles perpendicular to the skin by the dominant hand. The needle will be moved inside these muscles by flexion and extension movements of the wrist by pistoning method. To perform a dry needling in the upper trapezius muscle, the patient sleeps prone. In this position, the therapist finds the active trigger points of this muscle by pincer palpation with the non-dominant hand, and then the therapist inserts the needle into the muscle with his dominant hand and moves the needle towards the fingers of his non-dominant hand. In this position, with flexion and extension movements of wrist, the therapist moves the needle into the muscle. Side position is used for Dry needling in Levator scapula and Splenius cervicis and capitis muscles. In this situation, the therapist finds the trigger points of these muscles by pincer palpation with the non-dominant hand and then inserts the needle into these muscles with the help of the dominant hand. For the upper part of the Levator scapula muscle, the needle enters the muscle perpendicular to the skin, and for the lower part of this muscle, the needle enters the muscle in the outward and distal direction, towards the upper angle of the scapula. For the splenius capitis muscle, the needle enters inward and distally toward the fingers of non-dominant hand. For the cervical splenius muscle, the needle will be inserted perpendicular to the skin in a backward-forward direction. For sub occipital muscle dry needling in the prone position, the therapist inserts the needle perpendicular into the skin between the transverse process of the atlas vertebra and the spinous process of the second cervical vertebra. The direction of the needle is towards the eye on the opposite side. The treatment is continued until it is no longer LTR taken from the muscles. After taking the last LTR, the needle stays in place for 20 minutes, and after removing the needle, the exit point of the needle will be compressed for 60 seconds. Treatment will take six sessions, two weeks and three sessions a week. As a basic treatment, patients will receive exercises to improve posture and education to be aware of the nature of the disease and how to manage it. Control group: For Sham dry needling, the patient is placed in the position of a real dry needling and the same type of needle is used. The difference is that the needle is applied subcutaneously in a place farther from the marked points and After 20 minutes, remove the needle from the tissue and squeeze the area for 60 seconds. Treatment will take six sessions, two weeks and three sessions a week. As a basic treatment, patients will receive exercises to improve posture and education to be aware of the nature of the disease and how to manage it. Pain intensity according to visual analog scale. Timepoint: before intervention and 1 week after end of intervention. Method of measurement: Numeric Pain Rating Scale. Active range of motion of craniocervical vertebrae with manual goniometer. Timepoint: before intervention and 1 week after end of intervention. Method of measurement: Manual goniometer. Functional disability according to neck disability index. Timepoint: Before treatment and one week after treatment. Method of measurement: Neck disability index. Frequency of headache. Timepoint: Before treatment and one week after treatment. Method of measurement: Record days with headaches in a diary. Record the Dry needling side effect. Timepoint: Before treatment and one week after treatment. Method of measurement: record the Dry needling side effect. Iran University of Medical Sciences Approved 2021-06-29 Ethics committee of Iran University of Medical Sciences No.19, Rabiei hashemi alley, Ahmadisakha street, Qazvin avenue, Gomrok town Tehran Tehran Iran (Islamic Republic of)