<?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>IRCT20100827004641N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-09</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Biofeedback in myofacial neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Biofeedback therapy effect on myofacial neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34542</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who are eligible for inclusion in the study will be randomly assigned to three treatment groups using a randomized, randomized, randomized trial. In order to execute the randomization process to create random sequences, hide random effects and execute the random allocation process, this will be done:
Run the randomization process
A random sequence is created using the random numbers table and created by the statistician and will be available to him. The doctor will evaluate it in terms of entry and exit criteria based on the order in which the participants enter the study, and if the referral is eligible for inclusion in the study, he will be evaluated prior to the intervention and will record the relevant information. The patient will then undergo a washout period. Two hours before the next referral to the patient immediately after the wash out period and for intervention, the doctor will contact the patient by telephone or text message and will ask him / her about the random allocation of the participant to the specific group, Blinding description: Patients in each group are evaluated by an assistant physician who is not aware of the type of intervention, before the intervention, one week after the intervention and two months after the intervention, and the degree of variation between the three groups will be compared at different times. It should be noted that all interventions are carried out by persistent individuals (physicians and physicians).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofacial neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:In biofeedback sessions, patients learn how to relax their upper trapezius muscle through visual computerized feedback by electrical electromyography device (surface EMG). In case of muscle weakness, strengthening and endurance training sessions would be held for each individual patient using EMG-biofeedback system. Patients have 10 sessions of therapy. Intervention 2: Intervention group 2:  For physiotherapy sessions, we will use physical modalities such as hot pack, ultrasound and trans cutaneous electrical nerve stimulation (TENS) followed by cervical and shoulder range of motion and stretch exercises for cervical paraspinalis and upper trapezius muscle. Intervention 3: Intervention group 3: Those patients in biofeedback-physiotherapy group would receive both biofeedback and physiotherapy treatment.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Pishgahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Medicine and Rehabilitation Research Center of Tabriz, Imam Reza hospital, Golgasht st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 1336 4672</telephone>
        <email>Maryam_najafie@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Pishgahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Medicine and Rehabilitation Research Center of Tabriz, Imam Reza hospital, Golgasht st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 1336 4672</telephone>
        <email>Maryam_najafie@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1)To have a history of neck pain in last 3 month                                                                2)To have myofascial trigger points in upper trapezius muscle                                        3)To participate in the study with an Informed consent                                                                                                                                                                                     4)To be aged between 18-65</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1)To have a history of neck truma                                                                                                                   2)To have neck degenrative disorders                                                                                        3)To have neck radiculopathy                                                                                             4)To have Peripheral neuropathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Contracture of muscle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:In biofeedback sessions, patients learn how to relax their upper trapezius muscle through visual computerized feedback by electrical electromyography device (surface EMG). In case of muscle weakness, strengthening and endurance training sessions would be held for each individual patient using EMG-biofeedback system. Patients have 10 sessions of therapy.</i_keyword>
      <i_keyword>Intervention group 2:  For physiotherapy sessions, we will use physical modalities such as hot pack, ultrasound and trans cutaneous electrical nerve stimulation (TENS) followed by cervical and shoulder range of motion and stretch exercises for cervical paraspinalis and upper trapezius muscle.</i_keyword>
      <i_keyword>Intervention group 3: Those patients in biofeedback-physiotherapy group would receive both biofeedback and physiotherapy treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neck pain. Timepoint: Befor therapy and one mounth after therapy and three mounths after therapy. Method of measurement: VAS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck disability. Timepoint: Befor therapy and one mounth after therapy. Method of measurement: NDI questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-24</approval_date>
        <contact_name>Ethics commitee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>EmamReza hospital, Golbad ave. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
