<?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>IRCT20150602022539N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-19</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of myofascial release of psoas major muscle on lumbar spine kinematic and disability in the subjects with non-specific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of myofascial release of psoas major muscle on lumbar spine kinematic and disability in the subjects with non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Permuted block randomization will be used for randomization, which includes 4 blocks (2 participants in the intervention group and 2 participants in the control group). Random allocation software is also used for randomization tools. In order to create an allocation concealment, each random sequence created is recorded on a card and the cards are placed in sealed opaque envelopes, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, according to the order of arrival, one of the envelopes is opened in order and the assigned group of that participant is identified, Blinding description: In this study, blindness will be done in the participants. Participants from both groups will be admitted at different times for evaluation and intervention and will not be aware of the type of intervention of the other group.The implementation phase of this research is performed by another physiotherapist who is skilled in the field of manual therapies and the researcher who evaluates the outcome and
Data analysis is involved. It is unaware of the grouping of participants and receives the data without knowing the grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Symbolically receives the technique of releasing the myofascia of the Psoas major muscle in four periods of two weeks and for forty minutes on both sides. Intervention 2: Intervention group: receives the technique of releasing the myofascia of psoas major muscle for four periods in two weeks (twice a week) for forty minutes on both sides.</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 Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ziaeddin Safavi Farokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3013138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>ziasafavi@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ziaeddin Safavi Farrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3013138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>ziasafavi@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete satisfaction to participate in this study
People with nonspecific chronic low back pain with a minimum period of three months
Age between 20-45
Pain intensity3-6
Bilateral shortening of psoas major muscle
Disability grade 6-18 (from 24 points)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Having systemic fibromyalgia, Cauda equina syndrome, spinal tumor
Having autoimmune, infectious, vascular, endocrine, metabolic and neoplastic diseases
History of spinal surgery and other criteria contraindicating use of myofascial therapy
Have previous experience in myofacial treatment or a history of low back pain rehabilitation treatment in the last two months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Symbolically receives the technique of releasing the myofascia of the Psoas major muscle in four periods of two weeks and for forty minutes on both sides</i_keyword>
      <i_keyword>Intervention group: receives the technique of releasing the myofascia of psoas major muscle for four periods in two weeks (twice a week) for forty minutes on both sides.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Angular velocity during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</prim_outcome>
      <prim_outcome>Angular displacement during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</prim_outcome>
      <prim_outcome>Maximum range of motion during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Ronald-Morris Questionnaire.</prim_outcome>
      <prim_outcome>Relative phase during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Minimum phase angle during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</sec_outcome>
      <sec_outcome>Maximum phase angle during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</sec_outcome>
      <sec_outcome>Time to reach the maximum phase angle during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</sec_outcome>
      <sec_outcome>Time to reach the minimum phase angle during stand to sit and sit to stand. Timepoint: Before and immediately after the two-week intervention and one month after the intervention. Method of measurement: Motion analysis device.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-14</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan, km 5 of Damghan road, Semnan University of Medical Sciences semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
