<?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>IRCT20200518047498N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage on treatment of males upper trapezius active myofascial trigger points</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage on treatment of males upper trapezius active myofascial trigger points</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to www.randomization.com in three groups: WBV, HPPT US, and DTFM. Each participant is assigned a number, and then the numbers Through this site are randomly divided into three groups, Blinding description: Recording of initial evaluation information and marking of triggerpoint location and reassessment after treatment is performed by one therapist and treatment is performed by another therapist.</study_design>
      <phase>3</phase>
      <hc_freetext>myofascial trigger points.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (WBV Whole Body Vibration): Preliminary explanations about WBV (the vibrating machine to be used in this study will be Power plate, USA, which transmits energy simultaneously and based on the Mass spring system) and how The placement on the vibration surface is given to the person, so that the person is asked to place his hands with the full extension of the elbow so that the joint is not locked, in the middle of the Platform, so that the shoulders are in the flexion position at 90 and  There is no internal or external rotation in the upper limb. The head is placed in the direction of the trunk and spine and the person is asked to look at the ground so that it has no rotation or flexion and extension in the neck . The lower limb is kneeling (for safety on the ground). The person is asked to stick his hands firmly to the vibration plate and try to keep his position steady during the vibration. During the time the vibration is applied; If the person expresses discomfort, we will discontinue it. (39) WBV with a frequency of 30 Hz and a range of 5 mm, which includes 5 sets of one minute and one minute of rest between each set, is applied to the person . Intervention 2: Intervention group2(high power pain threshold ultrasound ): After an introductory explanation of the HPPT US technique, the patient lies in a prone position while the head is in the neutral position and the hands are placed next to the body.  the ultrasound probe is placed permanently on the trigger point. The frequency is set to one MHz, and the intensity is increased from 0.5 w / 〖cm〗 ^ 2 to allow the patient to feel the unpleasant sensation. then  the probe is hold for 4 seconds and then reduce the intensity by 50% and move the probe over and around the trigger point. This process is done several times over three minutes. Intervention 3: Intervention group3(deep transverse friction massage ): After an introductory explanation of the DTFM technique, the patient lies supine while the head is in the neutral position and the hands are on the side of the body. The application of force is done by using four fingers, which are reinforced by the middle finger. The force is applied slowly and with a little pain on the trigger point of the upper trapezius muscle for three minutes.</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>Iran Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No179,infront of drug store ,near moosavi st, somaye Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1581749711-4</zip>
        <telephone>+98 51 4426 3075</telephone>
        <email>dpttehran@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iran Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No179,infront of drug store ,near moosavi st, somaye Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1581749711-4</zip>
        <telephone>+98 51 4426 3075</telephone>
        <email>dpttehran@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 45 years
The dominance of the right hand
Ability to perform active movement in the full range of abduction and  scaption and internal rotation of the shoulder
There is only one trigger point in the upper trapezius muscle based on clinical findings that have the following characteristics:1- Touching the taut band inside the muscle2- Existence of a very sensitive point inside the taut  band3. The presence of pain  at least three based on the VAS scale in the initial evaluation4- The occurrence of a refferal and familiar pain pattern when stimulating a taut  band.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of shoulder surgery or trauma (dislocation, replacement, joint sprain) in the last 6 months
History of chronic or acute diseases such as neurological, cardiac and metabolic diseases
Pregnancy during the test
Skin lesions, infections or inflammation in the trigger point area
Take sedatives before or during treatment
History of neck trauma injuries (Wiplash injury)
History of neck surgery
Any malignancy and bad posture
Fibromyalgia syndrome
Drug abuse
Consumption of corticosteroids
reatment of trigger points in the past month
evere hearing problems - vision and color blindness
Epilepsy
Taking any medication or any specific illness that affects a person's cognitive symptoms
Drink any stimulant drink (such as tea, alcohol, coffee and cocoa) before the test session.
People with lower education than diplomas</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 (WBV Whole Body Vibration): Preliminary explanations about WBV (the vibrating machine to be used in this study will be Power plate, USA, which transmits energy simultaneously and based on the Mass spring system) and how The placement on the vibration surface is given to the person, so that the person is asked to place his hands with the full extension of the elbow so that the joint is not locked, in the middle of the Platform, so that the shoulders are in the flexion position at 90 and  There is no internal or external rotation in the upper limb. The head is placed in the direction of the trunk and spine and the person is asked to look at the ground so that it has no rotation or flexion and extension in the neck . The lower limb is kneeling (for safety on the ground). The person is asked to stick his hands firmly to the vibration plate and try to keep his position steady during the vibration. During the time the vibration is applied; If the person expresses discomfort, we will discontinue it. (39) WBV with a frequency of 30 Hz and a range of 5 mm, which includes 5 sets of one minute and one minute of rest between each set, is applied to the person .</i_keyword>
      <i_keyword>Intervention group2(high power pain threshold ultrasound ): After an introductory explanation of the HPPT US technique, the patient lies in a prone position while the head is in the neutral position and the hands are placed next to the body.  the ultrasound probe is placed permanently on the trigger point. The frequency is set to one MHz, and the intensity is increased from 0.5 w / 〖cm〗 ^ 2 to allow the patient to feel the unpleasant sensation. then  the probe is hold for 4 seconds and then reduce the intensity by 50% and move the probe over and around the trigger point. This process is done several times over three minutes.</i_keyword>
      <i_keyword>Intervention group3(deep transverse friction massage ): After an introductory explanation of the DTFM technique, the patient lies supine while the head is in the neutral position and the hands are on the side of the body. The application of force is done by using four fingers, which are reinforced by the middle finger. The force is applied slowly and with a little pain on the trigger point of the upper trapezius muscle for three minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The range of motion of the sideflexion of the neck that is 25 to 45 degrees. Timepoint: Three times before and immediately after treatment. Method of measurement: The patient is placed in a flat position with a 90-degree flexion of the knee and thigh while the hands are resting on the thighs. The method of measurement is that the Goniameter axis is placed on the spinous process of seventh cervical vertebra. the fixed arm of the Goniameter perpendicular to the ground and its movable arm is placed parallel to the hypothetical vertical line of the head. To measure range of motion, the movement of the head is placed in an anatomical position and the end of the movement of the ear is close to the shoulder.</prim_outcome>
      <prim_outcome>Pain Pressure threshold that the pressure sensation becomes a sensation of pain or discomfort. Timepoint: Three times before and immediately after treatment. Method of measurement: The algorithmic device has a disc with a cross-sectional area of 1 cm2, which is pressed perpendicular to the desired point, to start the patient's pain.This test is performed 3 times for each point with a time interval of 30 seconds and an average of three data is recorded.</prim_outcome>
      <prim_outcome>Pain measured by the visual scale of pain, which is between zero and ten. Timepoint: before and immediately after treatment. Method of measurement: The visual scale of the pain is a 100 mm unmarked ruler, with the number zero in the painless position and the number 100 in the most painful position. After acquainting the person with this diagram, we ask him to mark the amount of pain on the ruler. We then measure the distance from the zero point to the mark.</prim_outcome>
      <prim_outcome>Age. Timepoint: Before treatment, which should be between 18 and 45 years. Method of measurement: Through a questionnaire and by year.</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>2020-02-03</approval_date>
        <contact_name>Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences</contact_name>
        <contact_address>Floor 13th ,Block A,Central Headquarters of the Ministry of Health, Treatment and Medical Education ,Sima Iran St.Between Flamak South and Zarafshan, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
