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IRCT20220219054060N1 IRCT 2022-04-21 Iran University of Medical Sciences The effectiveness of exercises in comparison with manual treatments in chronic tension type headache The effectiveness of deep neck flexor exercises in comparison with myofascial release of suboccipital muscle on pain and forward head posture in people with chronic tension type headache and forward head posture 2022-04-21 anticipated 44 Complete https://irct.ir/trial/62011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This randomized clinical trial is of the double-dummy type. in this way, one group will receive deep neck flexor exercises with placebo treatment of myofascial release of suboccipital muscles and the other group will receive myofascial release of suboccipital muscles with placebo treatment of deep neck flexor exercises, Randomization description: All eligible patients with chronic tension-type headache are randomly divided into two groups of treatment: deep neck flexor exercise and myofascial release groups with a 1: 1 ratio. Generatorslist.com is used to determine random allocation; This method is done with the help of four-digit blocks including even and odd numbers. For this purpose, 4-digit numbers are selected that have 2 even digits and 2 odd digits; Each digit represents each participant in the study. The random allocation process will be performed by someone outside the research team before the study begins. At the end of the random allocation, the numbers will be placed inside the numbered envelopes separately and after the initial evaluation by the examiner, the numbered envelopes will be given according to the ordinal number of each person entered in the study. Finally, after each participant enters the treatment sessions, the therapist opens the envelope of the participants and applies therapeutic interventions based on the number in the envelope. Patients are told not to provide information about their group to the assessor to prevent data contamination, Blinding description: In this study, participants, the outcome assessor, and, the statistician will be blinded. Method of blindness: a) Participants: In each of the treatment groups, a real treatment was used with the placebo form of treatment of another group (the first group includes deep neck flexor exercise with placebo myofascial release, and the second group includes suboccipital myofascial release with placebo deep neck flexor exercise) so that the participants could not guess which treatment group they had entered; also, the participants will not be aware of how the other group will be treated. B) Outcome Assessor: Outcome assessment will be performed by a person who has no knowledge of the grouping of individuals and the treatments performed in each treatment group. C) Statistician: Data analysis will be performed by a person who does not know the grouping of people and the treatments performed in each treatment group. 3 chronic tension-type headache. Intervention 1: Intervention group 1: deep neck flexor exercises with pressure biofeedback combined with placebo myofascial release of suboccipital muscles. Intervention 2: Intervention group 2:sub-occipital myofascial release combined with placebo deep neck flexor exercises with pressure biofeedback. Yes - There is a plan to make this available What will be shared: Data collected after unidentifiable individuals are collected for primary and secondary outcomes and shared as needed. When: The access period starts 6 months after the results are published To whom: The data will be available to physiotherapists working in scientific institutions as well as clinicians working in the field of musculoskeletal disorders, especially in the head and cervical regions. Conditions: The raw data and results of this study may be used in systematic studies. Hence, the raw data and results of this study will be available to researchers working in the field of headache. Where to obtain: Applicants can contact Mobina Ahmadi (Physiotherapist) by e-mail. Email address: m.oahmadi@ymail.com How to obtain: Applicants must explain in detail about their project and how to use the data/documentation of this study in their project. Then, the data/documentation files will be sent to the applicants through e-mail following the request. This process may take 10-12 business days. Comments:
public Mobina Ahmadi
Unit 2, First Floor, Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1545912487 +98 21 2225 6434 m.oahmadi@ymail.com Iran University of Medical Sciences scientific Mohammadreza Pourahmadi
Department of Physiotherapy, Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) People with at least 2 of the 4 characteristics of bilateral headache, Non-pulsatile pain pressure, mild to moderate severity and no aggravation of pain by daily activities such as walking People who have experienced the headache for at least 3 months People who have the headache more than 15 days per month People who have only one of the symptoms of photophobia, phonophobia or mild nausea People with a craniovertebral angle less than 49 degrees The dose and type of prophylactic medication have not changed in the last 3 months People who do not intend to change the dose and type of prophylactic medication during the study period Participants have completed at least the elementary level of education and have the ability to understand and read Persian to complete the questionnaire. The headache can be accompanied by muscles tenderness around the head and neck 18 years 55 years Both People with dizziness, severe nausea or vomiting due to the headache People with episodic tension type headache or other primary and secondary headaches Pain aggravated by movement of the head َAbnormal changes in the radiographic image of cervical spine Previous trauma to the cervical spine Severe pain or significant limitation of the normal range of motion of the cervical spine History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment Joint stiffness, atherosclerosis or advanced osteoarthritis of the cervical spine Neurological or vascular disorders such as epilepsy or Bow hunter’s syndrome Absence of two consecutive sessions and more than treatment sessions Consume more than 200 pieces of morphine or other strong analgesics per month Pregnancy Receive physiotherapy treatment for headache within 6 months before starting treatment People who drink alcohol or have drug abuse For whatever reason, the participant is reluctant to be touched by the therapist Symptoms are severe and irritating Underlying diseases (such as rheumatoid arthritis) or metabolic disorders (such as osteoporosis or soft tissue laxity in the treatment area) for which manual therapies are contraindacated Score is more than 85 in the Spielberger Anxiety Trait Questionnaire G44.221 Chronic tension-type headache, intractable Rehabilitation Rehabilitation Intervention group 1: deep neck flexor exercises with pressure biofeedback combined with placebo myofascial release of suboccipital muscles Intervention group 2:sub-occipital myofascial release combined with placebo deep neck flexor exercises with pressure biofeedback. The average severity of headache during the last 1 month. Timepoint: Pain intensity will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention. Method of measurement: Visual Analogue Scale. The severity of forward head posture. Timepoint: Measurement of the forward head posture will be performed at the beginning of the study (before the start of the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention. Method of measurement: Craniovertebral angle: The angle between the horizon line and the line connecting the tragus of the ear to the spinous process of the seventh cervical vertebra. Duration of the headache. Timepoint: The duration of headache will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention. Method of measurement: The average number of hours that a person has the headache in a month. ّFrequency of the headache. Timepoint: The frequency of headaches will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention. Method of measurement: The number of days in the month when a person has a headache. Disability. Timepoint: Disability will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention. Method of measurement: Persian version of the Henry Ford Hospital Headache Disability Inventory questionnaire. Quality of life. Timepoint: Quality of life will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention. Method of measurement: Persian version of Headache Impact Test questionnaire -6. Pressure Pain Threshold of suboccipital muscles. Timepoint: The pressure Pain Threshold of suboccipital muscles will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention. Method of measurement: Algometer device in the lower part of the occipital bone and outside the upper head of the upper trapezius muscle on both sides. Iran University of Medical Sciences Approved 2022-03-16 Research Ethics Committees of Iran University of Medical Sciences Unit 2,First Floor,Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd. Tehran Tehran Iran (Islamic Republic of)