<?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>IRCT20210524051386N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of scapular muscles release technique on the thickness of scapular and neck muscles in patients with nonspecific neck pain: A Randomized Clinical Controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of axioscapular muscles release technique on the thickness of axioscapular and neck stabilizer muscles in patients with nonspecific neck pain: A Randomized Clinical  Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59981</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with non-specific neck pain who participated in this study will be divided into two groups A, B randomly, by statistical random allocation software. Then, for the ordering of people, randomly by software will be taken by the same person who is not a member of the project group, Blinding description: This is a single blind study. In this study, the patients were not blind.
The physiotherapist whose duty is patients physiotherapy treatment is also not blind. However, the physiotherapist whose duty is to evaluate at the beginning and end of the physiotherapy sessions is blind, and the radiologist whose duty is to ultrasound the muscles at the beginning and the end of the physiotherapy sessions is blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic nonspecific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: will be treated by routine physiotherapy and axioscapular muscle release technique, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we  will be used TENS  which is conventional mode for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound: that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and ... In a training file, and they will be treated by special myofacial release technique in the axioscapular muscles (upper and middle trapezius) for them. Intervention 2: Control group: will be treated by routine physiotherapy, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we will be used TENS which is conventional for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and... In a training file.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahram Amirshakri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilition Faculity of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166414766</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>amirshakerib@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahram Amirshakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilition Faculity of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166414766</zip>
        <telephone>+98 41 3384 5381</telephone>
        <email>amirshakerib@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients whose nonspecific neck pain has been diagnosed by a neurosurgeon
According to the physiotherapist, at least one active trigger point in the axioscapular muscles (upper trapezius and middle trapezius)
Visual Analogue Scale of neck pain at least 3, maximum 7
Neck Disability Index at least 10, maximum 40
At least three months have passed since the onset of neck pain
Normal Body Mass Index between 20 and 25</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients with neurological symptoms and radiculopathy in their upper extremities
Patients who have a pacemaker in the heart
Patients with a history of surgery in the neck and scapula
Patients who have a systemic rheumatic diseases
Patients with congenital malformations in the neck and scapula
Women who are pregnant
Patients with a history of trauma in the neck and scapula
Patients who have malignancy
People who received scapular muscle release treatment 1 month before the study started</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.29</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>intervention group: will be treated by routine physiotherapy and axioscapular muscle release technique, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we  will be used TENS  which is conventional mode for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound: that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and ... In a training file, and they will be treated by special myofacial release technique in the axioscapular muscles (upper and middle trapezius) for them.</i_keyword>
      <i_keyword>Control group: will be treated by routine physiotherapy, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we will be used TENS which is conventional for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and... In a training file.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thickness of upper trapezius, middle trapezius. Timepoint: Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later). Method of measurement: sonography siemens healthineers - acuson juniper.</prim_outcome>
      <prim_outcome>Cross sectional of longus colli, cervical multifidus. Timepoint: Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later). Method of measurement: sonography siemens healthineers - acuson juniper.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain intensity. Timepoint: Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later). Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Pressure Pain Threshold. Timepoint: Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later). Method of measurement: Digital Algometer.</sec_outcome>
      <sec_outcome>Neck disability. Timepoint: Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later). Method of measurement: Neck Disability Index Questionnaire (Iranian version).</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>2021-10-25</approval_date>
        <contact_name>Research Ethics Committees of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Rehabilitation  Faculty of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
