<?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>IRCT20220122053793N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Motor Control Training in Patients with Chronic Non-Specific Neck Pain</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Motor Control Training on Neck Disability Index, Proprioception and Craniovertebral Angle in Patients with Chronic Non-Specific Neck Pain: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61448</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the number of patients in each group, the type of treatment is written on a piece of paper as "control group treatment" or "intervention group treatment" and placed in opaque's sealed envelopes. Randomly removes one of the envelopes and treats the patient based on the type of treatment specified in it. And the envelopes are mixed again, Blinding description: The study will be  double-blinded . The participant will be blinded to the type of intervention in relation to their treatment group as well as the researcher who must enter the data into the relevant checklist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Non-Specific Neck Pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the first 10 sessions, for patients, first for 20 minutes hi-TENS (Conventional TENS) current and then for fifteen minutes the heat pack heat modality is used in the neck area. Muscle energy techniques for muscles Upper trapezius and  Levator scapula, Suboccipital and sternocleidomastoid with post-contraction relaxation technique with 20% of maximum voluntary isometric contraction for seven seconds and 3 times per side in each session. Intervention 2: Intervention group: Control group interventions + a combination of deep neck flexor and extensor muscles motor control exercises With seven to ten repetitions of each exercise twice a 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:
Raw study data and analysis will be provided to researchers upon request.

When:
After the publication of articles resulting from the research

To whom:
Researchers working in academic institutions

Conditions:
The data are only available to other researchers to study and evaluate treatment outcomes.

Where to obtain:
By sending an email to the responsible author

How to obtain:
By sending an email to the responsible author And documentary demand

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Najafi Visroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitations, Enghelab St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>atefenajafi.a@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Najafi Visroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitations, Enghelab St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>atefenajafi.a@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>)Occurrence of neck pain by touch, movement, or prolonged fixed positions of the neck in the posterior region of the neck between the upper neck line to the prickly appendage of the first thoracic vertebra
At least three months have passed since the first sign of pain
2Pain intensity greater than 3 on the numerical pain rating scale
A score greater than or equal to 10 in the Persian version of the Neck Disability Index Questionnaire
Age range 18 to 45 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spinal surgery and disc-related diseases
History of neck fracture or tumor
Cervical spine instability
Presence of any peripheral or central nervous  system disorders
Neck vascular disorder
History Accident or trauma to the neck
Receiving physiotherapy treatment in the last three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the first 10 sessions, for patients, first for 20 minutes hi-TENS (Conventional TENS) current and then for fifteen minutes the heat pack heat modality is used in the neck area. Muscle energy techniques for muscles Upper trapezius and  Levator scapula, Suboccipital and sternocleidomastoid with post-contraction relaxation technique with 20% of maximum voluntary isometric contraction for seven seconds and 3 times per side in each session.</i_keyword>
      <i_keyword>Intervention group: Control group interventions + a combination of deep neck flexor and extensor muscles motor control exercises With seven to ten repetitions of each exercise twice a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: NPRS (Numeric Pain Rating Scale) - VAS (Visual Analogue Scale).</prim_outcome>
      <prim_outcome>Active Range Of Motion in 6 main directions. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: Manual Goniometer.</prim_outcome>
      <prim_outcome>Craniovertebral Angle. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: Photogrammetry.</prim_outcome>
      <prim_outcome>Neck Proprioception. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: Cervical Joint Position Error (JPE) test.</prim_outcome>
      <prim_outcome>Neck Muscle Endurance. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: Cervical Extensor Endurance Test (CEET)                       Neck Flexor Endurance Test (NFET).</prim_outcome>
      <prim_outcome>Neck Disability Index. Timepoint: Before the intervention the end of the tenth session and the end of the sixth week. Method of measurement: Persian Version of Neck Disability Index Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-15</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Rehabilitation, Pich Shemiran,Enghelab St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
