<?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>IRCT20230212057390N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The myofascial trigger points release of longus colli muscle in neck pain</public_title>
      <acronym></acronym>
      <scientific_title>The effects of myofascial trigger points release of longus colli muscle on pain and range of motion in patients with neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72441</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated in the experiment, half assigned to the control group (n = 25) and half to the experimental group (n = 25) using the block randomization method.  The randomization was performed by an investigator who was not involved with participant intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The method of performing the myofascial release technique: For manual muscle release, while the patient is lying on his back, the head is slightly extended to provide sufficient access to the anterior region of the neck. The back of the index, middle, and ring fingers are placed under the sternocleidomastoid muscle and gently lifted. In contrast, the pads of the fingers are placed on the anterior surface of the transverse processes. Then, the fingers go back and towards the anterior cervical spine. It slides and sits directly on it. The longus colli muscle at that point is covered only by subcutaneous tissue and skin. In this case, the back of the fingers is placed in front of the trachea, and the tips of the fingers are placed under the carotid and sternocleidomastoid sheaths. Then, the manual release is done with a deep massage of the longus colli muscle. The release includes gentle massage of the muscle in a cranial-caudal way. The fingers are gently moved over the anterior surface of the cervical seals and transverse processes while the patient performs mild flexion-extension movements of the neck [9]. Another method of touching the trigger points in the longus colli muscle can be felt by placing the examining finger along the lateral border of the trachea between the sternocleidomastoid muscle and the thyroid cartilage, and by separating the muscle from the adjacent trachea, gently rocking it forward. When the finger hits the vertebral column, the area is examined for trigger points by cross-fiber palpation [8]. Intervention 2: Control group: Conducting ultrasound of the anterior neck region. The subject is informed that pulsed ultrasound will be used. They should not feel any heat or pain. Since this is a dummy method, such an adjustment will not make any real difference. Ultrasound lotion is applied on the front of the neck between the sternocleidomastoid muscle and trachea, and the ultrasound head is moved slowly on the front of the neck in the area of trigger points for 2 minutes. The device's timer will alert the therapist when 2 minutes have passed.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6710</telephone>
        <email>shahbazim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6710</telephone>
        <email>shahbazim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient shows at least mild disability, number 5-14, based on the Neck Disability Index (NDI) scale.
Complaints of chronic neck pain (more than 3 months)
When entering the study, patients should have at least 3 pain based on the VAS scale when performing neck movements.
Patients have not used painkillers 24 hours before the tests.
Being over 18 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Observation of any serious pathology such as specific neck pain and red flag symptoms such as cervical spine tumor, whiplash injury, neck fracture, and previous cervical spine surgery were excluded from the study.
Patients with a recent cerebrovascular stroke, myocardial infarction, chronic lung or kidney disease, serious medical or psychiatric conditions, or unstable dementia were also excluded.
Patients who do not want to participate in the study for any reason.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of muscle, fascia and tendon at neck level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The method of performing the myofascial release technique: For manual muscle release, while the patient is lying on his back, the head is slightly extended to provide sufficient access to the anterior region of the neck. The back of the index, middle, and ring fingers are placed under the sternocleidomastoid muscle and gently lifted. In contrast, the pads of the fingers are placed on the anterior surface of the transverse processes. Then, the fingers go back and towards the anterior cervical spine. It slides and sits directly on it. The longus colli muscle at that point is covered only by subcutaneous tissue and skin. In this case, the back of the fingers is placed in front of the trachea, and the tips of the fingers are placed under the carotid and sternocleidomastoid sheaths. Then, the manual release is done with a deep massage of the longus colli muscle. The release includes gentle massage of the muscle in a cranial-caudal way. The fingers are gently moved over the anterior surface of the cervical seals and transverse processes while the patient performs mild flexion-extension movements of the neck [9]. Another method of touching the trigger points in the longus colli muscle can be felt by placing the examining finger along the lateral border of the trachea between the sternocleidomastoid muscle and the thyroid cartilage, and by separating the muscle from the adjacent trachea, gently rocking it forward. When the finger hits the vertebral column, the area is examined for trigger points by cross-fiber palpation [8].</i_keyword>
      <i_keyword>Control group: Conducting ultrasound of the anterior neck region. The subject is informed that pulsed ultrasound will be used. They should not feel any heat or pain. Since this is a dummy method, such an adjustment will not make any real difference. Ultrasound lotion is applied on the front of the neck between the sternocleidomastoid muscle and trachea, and the ultrasound head is moved slowly on the front of the neck in the area of trigger points for 2 minutes. The device's timer will alert the therapist when 2 minutes have passed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of pain and range of motion. Timepoint: After the patient referred to the physical therapy center. Method of measurement: Pain is measured with a visual analog scale (VAS) and range of motion with a goniometer.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-04</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
