<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201116049403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-12</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>investigation the effect of neck and head massage on the intensity of pain, frequency of attacks and analgesic usage in patients with migraine</public_title>
      <acronym></acronym>
      <scientific_title>investigation the effect of neck and head massage on the intensity of pain, frequency of attacks and analgesic usage in patients with migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52468</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be assigned to the three groups of massage therapy, control and touch by randomization method based on sex classes (male and female) and duration of infection (5 years and less - more than 5 years). The entry of the first sample in the table is based on a lottery. For example, a man with a history of more than 5 years will be placed in the massage group by drawing lots between the three groups, the next people like him will be assigned to the touch and control group, respectively, and the rest will be a man with a history of less than 5 years. A woman with a history of more than 5 years and a woman with a history of less than five years will be performed in the same way to reach the quorum, Blinding description: n this study, participants in the non-pressure touch group are unaware of the placebo of this method. Also, the clinical caregiver of the touch group is unaware of the placebo of this study during the study. Data analyzer of which Reforms are not known to which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: massage group;In the massage therapy group, the method of massage will be taught by one of the researchers who has received the certification of the training course on massage therapy protocol, to a member of the patient's family who is introduced by the patient and the person volunteers to receive training and massage. After the training, the massage protocol will be repeated on the patient by the family member in the presence of the researcher to ensure accurate and complete learning.The massage will be performed by a trained family member of the patient. The intervention will be performed in a quiet, private, clean and hygienic room, safe, without noise and without disturbing the movement of others, with proper air conditioning and with the protection of the patient's privacy. The patient will wear disposable comfortable clothing so that his shoulders and neck are available for massage. The patient lies on a mattress that feels comfortable and the therapist is placed on top of the patient. The therapist also needs to wear comfortable and soft clothes to be able to perform massage movements gently and gently. Before starting the massage, the hands should be warm, and if the hands are cold, they should be gently warmed by rubbing the palms on top of each other. Baby oil is turquoise, it will be used for massage.Trapezius muscle massage: The massager is placed on top of the patient and the patient in the prone position and we use the skin roll technique (3 minutes), muscle roll (3 minutes) and needling (3 minutes). In the skin roll method, we use lifting the skin with the thumb by starting from the midline of the spine and continuing to the lateral end of the rotation of the scapula under the armpits on both sides, and from the shoulders from near the scapula to the base of the neck We continue. Muscle roll technique, which is done by applying pressure with the length of sixty fingers from the midline of the spine to the periphery at the site of the trapezius muscle, and the technique of needling, which is performed by direct pressure of the thumb on the sacrospinalis on both sides of the patient. Neck massage: To massage the neck, we use the prone position (2 minutes) and the needling technique, and with the fingers of both hands, we continue the massage from the back of the occiput to the area where the neck extends and below the scapular area. . In the lateral part of the neck (2 minutes) we use all the fingers and continue the protrusion of the trapezius. The palm while the fingers are in front of the upper fiber of the trapezius, we start kneading with pressure, then the patient in the lateral position (2 minutes) and then supine (2 minutes) and massage with your fingertips the muscles of the upper trapezius that is attached to the neck in the same way. Massage of the occipital frontal muscle: To massage the occipital frontal muscle of the patient in the supine position, we use the muscle stitching technique (2 minutes) by placing the palm of one hand on the forehead and the palm of the other hand under the sub-occipital muscle. We place the forehead and move it downwards or towards the eyebrows and the hand under the head upwards at the same time so that it feels like the scalp is moving forward and backward. Scalp massage: To perform this massage, three techniques of floristry (2 minutes), needling (2 minutes) and vibration (2 minutes) are used. In the flossing technique, the therapist places the fingers of both hands on both sides of the temporal area and the patient's scalp. Gently massage in a circular motion. In the needle massage technique, massage is performed on the whole skull, in the occipital frontal area and above the afferent massage area by the movements of all fingers. The vibration technique is common with the location of the needle method, so that the palms of both hands are on the area. Massage is performed and gentle reciprocating movements are performed in the form of vibration.Frontal area massage: Needing technique (2 minutes) and afferage (2 minutes) are used. In needling method, it is done using two, three or four fingers by massaging the midline of the forehead in the frontal and temporal directions. All fingers are used and the midline is drawn around and down in a curve (21). And 1 minute is spent rotating the patient. It should be noted that massage maneuvers will be performed with moderate pressure. The therapist made sure that his nails were not long and that he did not have a ring or ring in his hand so as not to damage the patient's skin. , Be comfortable and warm. All stages of massage in one step are taught in person with the patient and in the presence of the patient. Also a copy of the massage training video, to prevent possible forgetfulness. It is provided to the patient.The duration of the intervention will be 4 weeks, twice a week with a minimum interval of 48 hours between each session and each session will be performed for 30 minutes. Intervention 2: second intervention group: Touching the neck and neck exactly according to the massage method without applying pressure. Intervention 3: Control: No intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet due to financial problems.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zakieh Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.501. khaligefars building.west daneshvar. shahid tabdar blvd .</address>
        <city>Bandar abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919748306</zip>
        <telephone>+98 76 3334 1010</telephone>
        <email>faghihi_2020@ yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mrs. Dr. Tayebeh, the guard of Bonabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.501. khaligefars building.west daneshvar. shahid tabdar blvd .</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718967755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>negahbant@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the diagnosis of migraine by a neurologist using the International Index to diagnose headache for at least one year
Headaches occur at least four times a month (once a week)
Age over 18 years
Written consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>neurological disorders and other severe physical diseases and chronic systemic diseases
addiction to drugs and alcohol
Absence of wounds, thrombosis, hematoma, malignancy and skin changes and abnormalities in the head and neck areas that prevent massage
take anticoagulants
cardiovascular disease
pregnancy and lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: massage group;In the massage therapy group, the method of massage will be taught by one of the researchers who has received the certification of the training course on massage therapy protocol, to a member of the patient's family who is introduced by the patient and the person volunteers to receive training and massage. After the training, the massage protocol will be repeated on the patient by the family member in the presence of the researcher to ensure accurate and complete learning.The massage will be performed by a trained family member of the patient. The intervention will be performed in a quiet, private, clean and hygienic room, safe, without noise and without disturbing the movement of others, with proper air conditioning and with the protection of the patient's privacy. The patient will wear disposable comfortable clothing so that his shoulders and neck are available for massage. The patient lies on a mattress that feels comfortable and the therapist is placed on top of the patient. The therapist also needs to wear comfortable and soft clothes to be able to perform massage movements gently and gently. Before starting the massage, the hands should be warm, and if the hands are cold, they should be gently warmed by rubbing the palms on top of each other. Baby oil is turquoise, it will be used for massage.Trapezius muscle massage: The massager is placed on top of the patient and the patient in the prone position and we use the skin roll technique (3 minutes), muscle roll (3 minutes) and needling (3 minutes). In the skin roll method, we use lifting the skin with the thumb by starting from the midline of the spine and continuing to the lateral end of the rotation of the scapula under the armpits on both sides, and from the shoulders from near the scapula to the base of the neck We continue. Muscle roll technique, which is done by applying pressure with the length of sixty fingers from the midline of the spine to the periphery at the site of the trapezius muscle, and the technique of needling, which is performed by direct pressure of the thumb on the sacrospinalis on both sides of the patient. Neck massage: To massage the neck, we use the prone position (2 minutes) and the needling technique, and with the fingers of both hands, we continue the massage from the back of the occiput to the area where the neck extends and below the scapular area. . In the lateral part of the neck (2 minutes) we use all the fingers and continue the protrusion of the trapezius. The palm while the fingers are in front of the upper fiber of the trapezius, we start kneading with pressure, then the patient in the lateral position (2 minutes) and then supine (2 minutes) and massage with your fingertips the muscles of the upper trapezius that is attached to the neck in the same way. Massage of the occipital frontal muscle: To massage the occipital frontal muscle of the patient in the supine position, we use the muscle stitching technique (2 minutes) by placing the palm of one hand on the forehead and the palm of the other hand under the sub-occipital muscle. We place the forehead and move it downwards or towards the eyebrows and the hand under the head upwards at the same time so that it feels like the scalp is moving forward and backward. Scalp massage: To perform this massage, three techniques of floristry (2 minutes), needling (2 minutes) and vibration (2 minutes) are used. In the flossing technique, the therapist places the fingers of both hands on both sides of the temporal area and the patient's scalp. Gently massage in a circular motion. In the needle massage technique, massage is performed on the whole skull, in the occipital frontal area and above the afferent massage area by the movements of all fingers. The vibration technique is common with the location of the needle method, so that the palms of both hands are on the area. Massage is performed and gentle reciprocating movements are performed in the form of vibration.Frontal area massage: Needing technique (2 minutes) and afferage (2 minutes) are used. In needling method, it is done using two, three or four fingers by massaging the midline of the forehead in the frontal and temporal directions. All fingers are used and the midline is drawn around and down in a curve (21). And 1 minute is spent rotating the patient. It should be noted that massage maneuvers will be performed with moderate pressure. The therapist made sure that his nails were not long and that he did not have a ring or ring in his hand so as not to damage the patient's skin. , Be comfortable and warm. All stages of massage in one step are taught in person with the patient and in the presence of the patient. Also a copy of the massage training video, to prevent possible forgetfulness. It is provided to the patient.The duration of the intervention will be 4 weeks, twice a week with a minimum interval of 48 hours between each session and each session will be performed for 30 minutes.</i_keyword>
      <i_keyword>second intervention group: Touching the neck and neck exactly according to the massage method without applying pressure</i_keyword>
      <i_keyword>Control: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in Visual Analogue Scale and  Headache Impact Test-6 (HIT-6). Timepoint: Measurement of headache severity one month before the intervention, one month during the intervention and one month after the intervention. Method of measurement: Visual Analogue Scale، Headache Impact Test-6 (HIT-6).</prim_outcome>
      <prim_outcome>Number of attacks. Timepoint: Number of migraine attacks in one month before the intervention and one month during the intervention and one month after the intervention. Method of measurement: frequency of analgesic use.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-03</approval_date>
        <contact_name>Ethics committee of rafsangan University of Medical Sciences</contact_name>
        <contact_address>West daneshvar Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
