<?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>IRCT20240130060862N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-27</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of myofascial release and joint mobilization in cervicogenic headache subjects</public_title>
      <acronym></acronym>
      <scientific_title>The effect of myofascial release and joint mobilization based on diagnostic sub group, on headache index, rang of motion, thickness of upper cervical muscles and neck disability index in cervicogenic headache subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75445</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: The way of grouping is based on diagnosis and there is a diagnostic sub-group in each group. For the subgroups in each group, the same treatment will done, Randomization description: In this study, randomization is done according to the type of diagnosis (joint disorder, soft tissue disorder). volunteers are evaluated before randomization, and after the main cause of the problem is determined, they will be randomly assigned to one of the two interventions or control groups specific to their diagnosis. Considering that there are two subgroups in each intervention group, the treatment performed will be specific for one of the subgroups and not for the other subgroup. In each group, which people are placed in which subgroup is a random process, Blinding description: In this study, the participants are blind of their groupings.
Considering that there are 2 subgroups in each group, the therapist is blind  of which subgroup each candidate is in.
In this study, the outcome analyzer is blind of grouping and the group of each candidate.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cervicogenic headache.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: joint dysfunction treatment including joint mobilization technique based on diagnosed dysfunction which will be performed by a physiotherapist for ten sessions on a average day. Intervention 2: Second Intervention group: soft tissue dysfunction treatment include myofascial technique and ischemic compression on muscles which related on diagnosed dysfunction which will be performed by a physiotherapist for ten sessions on a average day. Intervention 3: Control group: Routine treatment based on guideline which mention on reference part which will be performed by a physiotherapist for ten sessions on a average day.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions

Conditions:
The use of data is free if it is for public benefit and with the reference of the source.

Where to obtain:
To receive data, applicants can refer to any of the researchers or contact the contact number or email of the person in charge

How to obtain:
After registering the application, the process of providing the data will be explained to the applicant and it will be delivered to her within 2 working weeks.(feminine)
Search for this on G

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences Iran university of Medical Sciences, Tavanbakhshi Alley, Shahnazari Ave, Madar Squair</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>akbari.mo@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Tavanbakhshi Alley, Shahnazari Ave, Madar Squair</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>Akbari.mo@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Subjects who has cervicogenic headache based on international headache society diagnostic criteria and reliable physical tests include flexion rotation test. Craniocervical flexion test. passive accessory intervertebral movement test. mastoid pressure pain test and sternocleidomastoid pressure pain test.
2. Subjects in 18-55 years old.
3. At least a history of three months of headache and recurrence once a month.
4. Having reading and writing literacy to write the questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Neurological problems of neck or other parts except headache.
2. Rheumatoid problems of spondylosis and severe degenerative changes of the neck.
3. Any history of head or neck surgery confirmed by a doctor.
4. Alar ligament instability or vertebrobasilar artery disorder.
5. History of any fracture in cervical or upper thoracic vertebrae.
6. Pregnancy
7. Thoracic scoliosis with Rib hump more than 8 mm.
8. Neonatal torticollis
9. General health problems such as hemophilia, diabetes, lung diseases, metabolic diseases and any history of cancer.
10. Mental disorders diagnosed by a psychiatrist. Like depression with drug use.
11. Receiving physiotherapy, chiropractic, osteopathy, massage therapy or other treatments in the neck or upper thoracic region recently or in the last three months.
12. Consuming caffeine less than 4 hours before the primary test.
13. Drug addiction
14. Having a BMI above 30.
15. Disruption in the treatment process and failure to complete 10 treatment sessions for any reason.
16. Difficulty in communicating effectively</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIII</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>disease of musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: joint dysfunction treatment including joint mobilization technique based on diagnosed dysfunction which will be performed by a physiotherapist for ten sessions on a average day.</i_keyword>
      <i_keyword>Second Intervention group: soft tissue dysfunction treatment include myofascial technique and ischemic compression on muscles which related on diagnosed dysfunction which will be performed by a physiotherapist for ten sessions on a average day.</i_keyword>
      <i_keyword>Control group: Routine treatment based on guideline which mention on reference part which will be performed by a physiotherapist for ten sessions on a average day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache index questionnaire include frequency, duration and intensity of headache. Timepoint: Before the intervention and after completing 10 intervention sessions and 3 months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Headache disability inventory questionnaire. Timepoint: Before the intervention and after completing 10 intervention sessions and 3 months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Neck pain and disability scale questionnaire. Timepoint: Before the intervention and after completing 10 intervention sessions and 3 months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Upper cervical muscle thickness. Timepoint: Before the intervention and after 5 session of intervention and after completing 10 intervention sessions. Method of measurement: Musculoskeletal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Head and neck range of motion in 3 plan of movement. Timepoint: Before the intervention and after the completion of 5 intervention sessions and after the completion of 10 intervention sessions. Method of measurement: Goniometry based on degrees.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-11</approval_date>
        <contact_name>ethics committee of Iran university of medical sciences</contact_name>
        <contact_address>No 1, hosseynieh alley, dolat Ave, tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
