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IRCT20200129046302N1 IRCT 2020-02-26 Iran University of Medical Sciences The Investigation of the Effects of Deep Dry Needling in Females with Episodic Tension Type Headache The Investigation of the Effects of Deep Dry Needling into Trigger Points of Temporalis, Sternocleidomastoid and Upper Trapezius on Females with Episodic Tension Type Headache 2019-03-06 anticipated 26 Complete https://irct.ir/trial/45485 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to the intervention or control groups. The random allocation method of these two groups will be block randomization. Block size will comprise 6 persons (overall there will be 4 blocks). Random allocation software will be used to determine the sequence of patient's allocation to each group, Blinding description: Pre-treatment,post-treatment assessments will be performed by the physiotherapist who is supposed to be blinded to the allocation concealment. N/A Episodic tension type headache. Intervention 1: Intervention group:Single session treatment with deep dry needling(Dongbang model, South Korea, 50*0/3 mm)in the trigger points of the Temporalis, Sternocleidomastoid and upper Trapezius muscles in both sides(after obtaining one local twitch response ,the needle will be inserted 8 times with fast in fast out technique )following with passive stretching( 4 seconds of stretching and 8 seconds of rest , this cycle will be repeated 3 times for each muscle). Intervention 2: Control group: Single session of passive stretching in the Temporalis, Sternocleidomastoid and upper Trapezius muscles in both sides (4 seconds of stretching and 8 seconds of rest , this cycle will be repeated 3 times for each muscle). Yes - There is a plan to make this available What will be shared: all data will be shared after unidentified persons. When: accessibility will be 6 months after printing the result. To whom: all researchers and scientists, working in academic and scientific institutions, can access to data. Conditions: Using of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article. Where to obtain: faezeh_abaschian@yahoo.com How to obtain: If data is used in scientific and therapeutic activities, information will be provided within 2 weeks. Comments:
public Faezeh Abaschian
No18.Shahid Ahmadian Ave,Torkamenstan Str.Motahari Str
Tehran Iran (Islamic Republic of) 23478-87688 +98 21 8844 6048 faezeh_abaschian@yahoo.com Iran University of Medical Sciences scientific Soheil Mansour Sohani
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd
Tehran Iran (Islamic Republic of) ۱۳۴۸۷ - ۱۵۴۵۹ +98 21 2222 2059 mansorsohani.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Having a diagnosis of Episodic tension type headache (ETTH) based on the International Classification of Headache Disorders(ICHD-3) Having at least one active trigger point in one of the given muscles : Temporalis(Left or Right), upper Trapezius(Left or Right) , Sternocleidomastoid (Left or Right) 18 years 50 years Female Having primary or secondary headaches History of neck injury Acute depression History of surgery in neck and shoulder Cervical radiculopathy History of dry needling treatment in the neck or head for the past six months Pregnant women G44.21 Episodic tension-type headache Rehabilitation Rehabilitation Intervention group:Single session treatment with deep dry needling(Dongbang model, South Korea, 50*0/3 mm)in the trigger points of the Temporalis, Sternocleidomastoid and upper Trapezius muscles in both sides(after obtaining one local twitch response ,the needle will be inserted 8 times with fast in fast out technique )following with passive stretching( 4 seconds of stretching and 8 seconds of rest , this cycle will be repeated 3 times for each muscle). Control group: Single session of passive stretching in the Temporalis, Sternocleidomastoid and upper Trapezius muscles in both sides (4 seconds of stretching and 8 seconds of rest , this cycle will be repeated 3 times for each muscle). Headache intensity. Timepoint: Headache intensity assessment at the baseline(4 weeks before intervention) and 4 weeks after intervention. Method of measurement: Visual analogue scale. Headache frequency. Timepoint: Headache frequency assessment at the baseline(4 weeks before intervention) and 4 weeks after intervention. Method of measurement: The number of days with headache within 4 weeks. Neck range of motion. Timepoint: At the beginning of the intervention , immediately , 2 and 4 weeks after intervention. Method of measurement: Goniometer. Mouth opening range of motion. Timepoint: At the beginning of the intervention , immediately , 2 and 4 weeks after intervention. Method of measurement: Ruler. Trigger points pain pressure threshold. Timepoint: At the beginning of the intervention , immediately , 2 and 4 weeks after intervention. Method of measurement: Algometer. Quality of life. Timepoint: before intervention and 4weeks after intervention. Method of measurement: SF-36 Quality of life Questionnaire. Sleep quality. Timepoint: before intervention and 4weeks after intervention. Method of measurement: Pittsburgh sleep quality questionnaire. Iran University of Medical Sciences Approved 2019-02-23 •Ethics committee of Iran university of medical sciences Iran university of medical sciences, next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)