<?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>IRCT20160621028567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-10</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>The comparison of effect of dry needling and ischemic compression for cervicogenic headache</public_title>
      <acronym></acronym>
      <scientific_title>A Sonographic Comparison of Effect of Dry Needling and Ischemic Compression on Active Trigger Point of the Sternocleidomastoid Muscle associated with Cervicogenic Headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By simple randomization method, subjects were assigned to ischemic compression group(n=9), dry needling group (n=10), or control group (n=10). The sealed envelope was used for randomized allocation of subjects to the groups. In this way, subjects selected one of 29 similar sealed envelopes. Inside the envelopes were the name of one of the three groups that led to the assignment of the subjects to that group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervicogenic headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: ischemic compression. Subjects in the ischemic compression group were asked to lie in a supine position with their heads in contralateral rotation, the trigger point taut band was grasped between the clinician’s thumb and index finger and for 30-60 seconds maximal tolerable pressure was applied. This process was repeated three times with 30-second intervals. If the headache pattern was reproduced or the pain disappeared, ischemic compression was discontinued. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session. Intervention 2: Intervention group: dry needling. For the dry needling group, subjects were supine with neutral head, the trigger point was grasped between the clinician’s thumb, index, and middle fingers and a 0.25×40mm needle (DongBang Acuprime) was repeatedly inserted in the anterior-posterior direction as long as local twitch responses were extinct. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session. Intervention 3: Control group: no intervention. Subjects in the control group did not receive any treatments.</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:
part of data

When:
6 months after publication

To whom:
Researchers

Conditions:
for treatment and research goals

Where to obtain:
Dr Farid Bahrpeyma bahrpeyf@modares.ac.ir

How to obtain:
Confirmation of advisor professor

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farid Bahrpeyma</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Ale Ahmad, Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3819</telephone>
        <email>bahrpeyf@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farid Bahrpeyma</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Ale Ahmad, Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3819</telephone>
        <email>bahrpeyf@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cervicogenic headache
Active trigger point in the sternocleidomastoid muscle inducing headache</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Other types of headache
Active trigger points in the other muscles of neck and face
Needle phobia
Rheumatological diseases
Neck and shoulder surgery
Any contraindications for interventions</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: ischemic compression. Subjects in the ischemic compression group were asked to lie in a supine position with their heads in contralateral rotation, the trigger point taut band was grasped between the clinician’s thumb and index finger and for 30-60 seconds maximal tolerable pressure was applied. This process was repeated three times with 30-second intervals. If the headache pattern was reproduced or the pain disappeared, ischemic compression was discontinued. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session.</i_keyword>
      <i_keyword>Intervention group: dry needling. For the dry needling group, subjects were supine with neutral head, the trigger point was grasped between the clinician’s thumb, index, and middle fingers and a 0.25×40mm needle (DongBang Acuprime) was repeatedly inserted in the anterior-posterior direction as long as local twitch responses were extinct. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session.</i_keyword>
      <i_keyword>Control group: no intervention. Subjects in the control group did not receive any treatments.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache intensity. Timepoint: At the beginning of the study, two weeks after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache.</prim_outcome>
      <prim_outcome>Headache duration. Timepoint: At the beginning of the study, two weeks after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache.</prim_outcome>
      <prim_outcome>Headache frequency. Timepoint: At the beginning of the study, two weeks after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Elastic modulus. Timepoint: At the beginning of the study, two weeks after end of intervention. Method of measurement: Ultrasound.</sec_outcome>
      <sec_outcome>Trigger point area. Timepoint: At the beginning of the study, two weeks after end of intervention. Method of measurement: Ultrasound.</sec_outcome>
      <sec_outcome>Pressure pain threshold. Timepoint: At the beginning of the study, two weeks after end of intervention. Method of measurement: Force gauge.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-22</approval_date>
        <contact_name>Committee of Ethics in Biomedical Research, Tarbiat Modares University</contact_name>
        <contact_address>Jala Ale Ahmad, Nasr Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
