<?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>IRCT20220830055832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Yu Mi Ho therapy massage on men with back pain caused by trigger points.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Yu Mi Ho therapy massage on pain, proprioception, range of motion of the back and shoulders in men with back pain caused by trigger point</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the limited randomization method for all study groups with equal sample size, and among the types of limited randomization methods, we will use the assigned law randomization to achieve a balance in the number of people assigned to the study groups. . First, we write the names of 30 people from the samples on the ball and put them in the box. We remove the balls from the box at random and without replacement. The 15 balls that we took out of the box at the beginning are called the intervention group and the 15 balls that are left are called the control group. Since it is not possible to reveal the random sequencing and to know the next assignment, concealment will not be performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>trigger point.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Yo Mi Ho therapy program will be applied to the back area and trigger points for 6 weeks (3 sessions per week and each session lasts 30 minutes). Intervention 2: Control group: The control group will continue their normal life during this period.</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:
All data related to people who participate as a sample in this research will be shared after de-identification.

When:
The access period starts 6 months after the results are published.

To whom:
The documents of this research are available to researchers working in academic institutions, physiotherapists and physical medicine specialists.

Conditions:
In order to prevent harm, in the centers where there are people with the problem mentioned in the research.

Where to obtain:
Reza Samadi
Phone:  00989013105153
Email: Rezasamadiii1373@gmail.com

How to obtain:
Checking the application, checking the applicant's documents, sending the required documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Arghvanieh, East J St., Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 5353 4001</telephone>
        <email>Rezasamadiii1373@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Arghvanieh, East J St., Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 5353 4001</telephone>
        <email>Rezasamadiii1373@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of a hidden trigger point in the back areaTranslate.
Male gender</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Manifestation of the trigger point in the back area
The presence of pain that prevents massage
The presence of damage in the shoulder joint
Neuralgic injuries of the back area</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Yo Mi Ho therapy program will be applied to the back area and trigger points for 6 weeks (3 sessions per week and each session lasts 30 minutes).</i_keyword>
      <i_keyword>Control group: The control group will continue their normal life during this period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Back pain. Timepoint: The beginning of the study (before the intervention) and 6 weeks after that. Method of measurement: A pain ruler will be used to determine the amount of back pain when pressing the trigger point. It is like a line 100 mm long, where the number zero indicates the absence of pain and the number 10 indicates the maximum amount of pain. According to the amount of pain they have had in the past 24 hours, the subjects draw a line around the stickers that are on the ruler and express the intensity of the pain, then by measuring the desired point, the intensity of the pain is measured in millimeters. . Numbers in the range of 0-10 mm indicate no pain, 10-30 mm indicate mild pain, 40-60 mm indicate moderate pain, and 70-100 mm indicate severe pain.</prim_outcome>
      <prim_outcome>Dorsiflexion range of motion. Timepoint: The beginning of the study (before the intervention) and 6 weeks after that. Method of measurement: Schuber's test will be used to evaluate the dorsiflexion range of motion. First, the shock appendage of the seventh cervical vertebra is marked, and then the shock appendage of the last dorsal vertebra is identified and this distance is measured with a tape measure. Then, the person will be asked to do spinal flexion and this distance will be measured again. In this case, the distance obtained in the standing position will be subtracted and the final measurement will be recorded.</prim_outcome>
      <prim_outcome>Internal rotation range of motion. Timepoint: The beginning of the study (before the intervention) and 6 weeks after that. Method of measurement: In this measurement, the patient is placed lying on his back. The hand whose range of internal rotation should be measured is placed in the position of 90 degrees of shoulder abduction and 90 degrees of elbow flexion. To neutralize the arm and prevent extra movements in the shoulder joint, a folded towel is placed under the person's arm and the lower part of the arm is kept steady. Layton's flexometer is tightly and closed to the outer middle part of the forearm and one of its plates is locked. The arm on the opposite side is also placed freely next to the body. In this case, the person's forearm actively moves down as far as possible, and at the end of the range of motion, the other Eton indicator is locked. The obtained size is recorded.</prim_outcome>
      <prim_outcome>External rotation range of motion. Timepoint: The beginning of the study (before the intervention) and 6 weeks after that. Method of measurement: In this measurement, the patient is lying on his back. The hand whose range of external rotation should be measured is placed in a position of 90 degrees of shoulder abduction and 90 degrees of elbow flexion. To neutralize the position of the arm and prevent excess movements in the shoulder joint, a folded towel is placed under the person's arm and the lower part of the arm is kept steady. Layton's flexometer is tightly tied to the middle outer part of the forearm and we lock one of its plates. The arm on the opposite side is also placed freely next to the body. In this case, the person's forearm actively moves up and back as far as possible and is locked at the end of the range of motion of the other Leighton indicator. The obtained size is recorded in a special data measurement form.</prim_outcome>
      <prim_outcome>Deep feelings. Timepoint: The beginning of the study (before the intervention) and 6 weeks after that. Method of measurement: 50% of the range of motion of the internal rotation of the shoulder was considered as the target angle in the reconstruction of the angle for the evaluation of depth perception. In the next step, for the test of active angle reconstruction, the target organ was taken to the target angle by the patient with open eyes and with the guidance of the examiner, and while it was held for 5 to 10 seconds; The patient was asked to memorize the angle and this process was repeated three times. Then the patient was asked to slowly move the limb to the desired angle. The active angle reconstruction test was repeated three times and the average error of three times of angle reconstruction was recorded under the title of absolute reconstruction error, which will be evaluated 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-30</approval_date>
        <contact_name>Ethical Committee of Isfahan Azad University (Khorasgan)</contact_name>
        <contact_address>University Blvd,  Arghvanieh,  East J St., Esfahan Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
