<?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>IRCT20171111037368N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Iranian traditional massage on chronic neck pains</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effectiveness of one type of Iranian traditional massage (Dalk and Ghamz) On chronic neck pains</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27664</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Neck Pain With Mobility Deficits. Condition 2: Neck Pain With Mobility Deficits. Condition 3: Neck Pain With Headache. Condition 4: Neck Pain With Movement Coordination Impairment. Condition 5: Neck Pain With Radiating Pain.</hc_freetext>
      <i_freetext>The selection of the patient to enter the study is among the patients with neck pain that has criteria for entry. Initially, the individual patient information and disease characteristics (duration, symptoms, accompanying illnesses, treatments, medications, etc.) and patient records are reviewed. The procedure for entering patients is twofold: the first group of patients who have already been fully evaluated by the specialist for reasons of cervical pain and who do not have exclusion criteria and who do not need a re-examination by a physician. And will be directly included in the study by the researcher himself. The second group of patients who do not have the necessary examinations should first be examined by a physical therapist and then enter the study. After describing the goals and method of work and signing the written consent of the patient, the intervention on the patient is done as follows:                1. Preparation: The patient is sitting at the edge of the bed (hanging legs) and the massager stays in front of the patient and The head, neck and shoulders are covered with scarves or thin linen.                                            2.  Determining the location of massage : Locating spasms by the patient, showing the patient's location of pain and spasm to the massager . Determine the location of spasms by the massager: Massage areas can be identified by seeing more prominent areas or the amount of movement restrictions in the neck and shoulders area or touching the painful areas and more prominent (with disposable gloves and without using oil at the tip of the first, second and third fingers).                                                        3. The release of spasms with the help of technique "Ghamz and Dalk" .  Ghamz techniques : At this stage, we stimulate the location of spasms with the help of fingertips in a transverse direction relative to the muscle path, from 5 to 10 times depending on the patient's tolerance. Dalk Technique: At this stage, massage is done with the help of finger tips in the longitudinal direction of the muscle, 5 to 10 times from the top down and from the posterior to the front. The duration of massage per session is ten minutes. The number of sessions, four sessions, and intervals of one week. The limitation of movement in the neck area will be evaluated before and after each intervention by a digital goniometer . Also, the rate of neck disability and quality of life of the patient will be evaluated before the intervention, the end of the intervention and one month after the last intervention..</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>Mansour Khoramizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 847 , Behesht Street Beginning, the south side of City Park, Vahdat-e-Islami St, Hassan Abad Square, School of persian medicine</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۴۷۳۳۳۱۱</zip>
        <telephone>+98 21 5563 9667</telephone>
        <email>khoramizadeh.m@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoorieh Mohammadi Kenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 847 , Behesht Street Beginning , the south side of City Park, Vahdat-e-Islami St, Hassan Abad Square, School of Persian Medicine</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۴۷۳۳۳۱۱</zip>
        <telephone>+98 21 5563 9667</telephone>
        <email>hmk1358@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent
Age of 18 to 70 years
Pain in the neck
More than three months from the onset of pain in the neck (continuous or alternating)
Disrupting some routine tasks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Upper limb neurological symptoms
Severe psychiatric illnesses
Pregnancy
Any damage to the nerves or under the pressure of the spinal cord
A report on pathology and neck surgery and cancer
History of fracture and dislocation on the neck region
History of severe cervical disorder such as a herniated disc
Hemophilia
Diabetic neuropathy
Epilepsy
Deep venus thrombosis
Anaphylaxis
Taking anticoagulants such as Warfarin
There is a scar on the neck
Peripheral nerve lesions and malignancy and cancer in the neck area
Fever and severe headache and meningitis symptoms
Patients who have not completed their treatment sessions
Patient dissatisfaction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.2</hc_code>
      <hc_code>M54.6</hc_code>
      <hc_code>R51</hc_code>
      <hc_code>S13.4</hc_code>
      <hc_code>M50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicalgia</hc_keyword>
      <hc_keyword>Pain in thoracic spine</hc_keyword>
      <hc_keyword>Headache</hc_keyword>
      <hc_keyword>Sprain of ligaments of cervical spine</hc_keyword>
      <hc_keyword>Cervical disc disorder with radiculopathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The selection of the patient to enter the study is among the patients with neck pain that has criteria for entry. Initially, the individual patient information and disease characteristics (duration, symptoms, accompanying illnesses, treatments, medications, etc.) and patient records are reviewed. The procedure for entering patients is twofold: the first group of patients who have already been fully evaluated by the specialist for reasons of cervical pain and who do not have exclusion criteria and who do not need a re-examination by a physician. And will be directly included in the study by the researcher himself. The second group of patients who do not have the necessary examinations should first be examined by a physical therapist and then enter the study. After describing the goals and method of work and signing the written consent of the patient, the intervention on the patient is done as follows:                1. Preparation: The patient is sitting at the edge of the bed (hanging legs) and the massager stays in front of the patient and The head, neck and shoulders are covered with scarves or thin linen.                                            2.  Determining the location of massage : Locating spasms by the patient, showing the patient's location of pain and spasm to the massager . Determine the location of spasms by the massager: Massage areas can be identified by seeing more prominent areas or the amount of movement restrictions in the neck and shoulders area or touching the painful areas and more prominent (with disposable gloves and without using oil at the tip of the first, second and third fingers).                                                        3. The release of spasms with the help of technique "Ghamz and Dalk" .  Ghamz techniques : At this stage, we stimulate the location of spasms with the help of fingertips in a transverse direction relative to the muscle path, from 5 to 10 times depending on the patient's tolerance. Dalk Technique: At this stage, massage is done with the help of finger tips in the longitudinal direction of the muscle, 5 to 10 times from the top down and from the posterior to the front. The duration of massage per session is ten minutes. The number of sessions, four sessions, and intervals of one week. The limitation of movement in the neck area will be evaluated before and after each intervention by a digital goniometer . Also, the rate of neck disability and quality of life of the patient will be evaluated before the intervention, the end of the intervention and one month after the last intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neck Pain. Timepoint: Before and after each intervention (first, one, two, three weeks later), one month after the last intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The range of motion in the neck and shoulders. Timepoint: Before and after each intervention (first, one, two, three weeks later), one month after the last intervention. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Neck Disability. Timepoint: Start of intervention, at the end of the intervention (fourth session), one month after the end of the intervention. Method of measurement: Neck disability index questionnaire &amp; neck pain and disability scale scoring questionnaire.</sec_outcome>
      <sec_outcome>Quality of life score. Timepoint: Start of intervention, at the end of the intervention (fourth session), one month after the end of the intervention. Method of measurement: Quality of life questionnaire SF-36.</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>2017-10-28</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No.1, Mansouri alley, prayer street,  Sattar Khan street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
