<?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>IRCT20171219037956N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-11</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Effects of dry needling and soft tissue release in treatment of migraine patients</public_title>
      <acronym>DNSTR</acronym>
      <scientific_title>The effects of treating  myofascial trigger points of neck using the techniques of dry needling and soft tissue release on the  clinical feature of patients with migraine headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization, Blinding description: Double-blind study will be done,in this way, the allocation of people to the groups and the assessment of patients are done by people who are unaware of the status of the grouping of patients.Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Migraine patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dry needling. Intervention 2: Intervention group: Soft tissue release. Intervention 3: Control group: Placebo control.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the data, such as information about the consequences, can be shared

When:
Starting the access period: 6 months after publition the results

To whom:
Researchers working in academic and academic institutions

Conditions:
Only statistical analyzes can be used to find treatment for improvement of patients

Where to obtain:
Applicants can be guided by email authors

How to obtain:
First, they will email the authors of the study and we Will be answered within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0039</telephone>
        <email>tahere.rezaiyan@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahere Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7185796184</zip>
        <telephone>+98 21 2218 0039</telephone>
        <email>tahere.rezaiyan@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.	A neurologist selected the study subjects based on IHS criteria for diagnosis of migraine.
2.	The patients in this study were between the ages of 25 and 55 years old
The patients with migraine were examined to find any active trigger points in UT, SCM, sub-occipital muscles . The presence of active trigger points was confirmed if “1- There was an area of focal muscle tenderness that was activated by palpation and that, when activated, referred pain replicating the patient’s headache complaint. 2- There was a jump sign that was the characteristic behavioral response to pressure on a trigger point” .
One diagnostic test in particular, the flexion–rotation test, is said to determine C1-2 dysfunction .Patient was supine position. With the subject relaxed and the cervical spine is fully flexed with the occiput resting against the examiners. The head is then rotated to the left and the right. If firm resistance is percieved, pain provoked and range is limited before the expected end range .The normal range is reported at 44-45 degrees, therefore, the test is positive when the range of motion is more than 10 degrees from the normal range.Studies have shown that migraine  has a small effect on the range of motion during this test, but this test shows the presence or absence of cervicogenic headache and this test can use for Differential Diagnosis between migraine headache and cervicogenic headache.The positive test indicates a cervicogenic headache</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of cervical disc herniation, unusual migraine, heart failure, pulmonary failure, kidney failure, liver failure, circulation failure, diabetes mellitus
patients who were using opioid prophylaxis, anti -depressant, anti-anxiety drugs
subjects who were pregnant or breastfeeding and
Those who having trigger point therapy within the past month before the study
The patients, who underwent DN, had no contraindication for needling such as local infection, pregnancy with threatened abortion, taking anticoagulants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I67.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified cerebrovascular diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dry needling</i_keyword>
      <i_keyword>Intervention group: Soft tissue release</i_keyword>
      <i_keyword>Control group: Placebo control</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-Headache frequency. Timepoint: Before,After and 1month follow up. Method of measurement: Daily note form.</prim_outcome>
      <prim_outcome>2-Headache intensity. Timepoint: Before,After and 1month follow up. Method of measurement: Daily note form.</prim_outcome>
      <prim_outcome>3-Headache duration. Timepoint: Before,After and 1month follow up. Method of measurement: Daily note form.</prim_outcome>
      <prim_outcome>Number of drug consumption. Timepoint: Before,After and 1month follow up. Method of measurement: Daily note form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>1.Pressure pain threshold. Timepoint: Before, After and 1month follow up. Method of measurement: Algometer.</sec_outcome>
      <sec_outcome>2-Muscle thickness. Timepoint: Before, After and 1month follow up. Method of measurement: Ultrasonography.</sec_outcome>
      <sec_outcome>3-Range of motion. Timepoint: Before, After and 1month follow up. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>4-Neck disability index. Timepoint: Before, After and 1month follow up. Method of measurement: Neck disability index questionnaire.</sec_outcome>
      <sec_outcome>5-Head disability index. Timepoint: Before, After and 1month follow up. Method of measurement: Head disability index questionnaire.</sec_outcome>
      <sec_outcome>6-Pain intensity. Timepoint: Before, After and 1month follow up. Method of measurement: Visual analog scale.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-19</approval_date>
        <contact_name>Ethics Committee of the University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar St., Daneshjoo Blvd,Velenjak,  Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
