<?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>IRCT20160808029264N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-18</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>the effect of fascia release in non-specific chronic back pain patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of lumbar spine muscles myofascial release with remote myofascial release of lower limb muscles on the ultrasonography parameters of myofascial system and function in  patient with chronic nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76770</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using a random table, the patient will be randomly assigned into the groups by choosing the number, Blinding description: Patients do not know which group they are in. The evaluator of study outcomes will also not know about the grouping of patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>non specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groIntervention group: The interventions performed in this group include the release of spinal fascia such as quadratus lumborum, erector spinae, thoracolumbar fascia and soas for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed. Intervention 2: Intervention grouIntervention group: The interventions performed in this group include the release of lower limb fascia such as gastrocnemius, soleus, plantar fascia, and hamstring for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed.p:. Intervention 3: Control group: routine electrotherapy is performed in this group.</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>mansourehrahbary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Ali Square, , Golestan Golshan St No91</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519845358</zip>
        <telephone>+98 23 3334 45230</telephone>
        <email>mansourehrahbary@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasool Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513135111</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>rasool.bagheri@ymail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria for the study included people aged 18-45 who had non-specific chronic back pain that lasted for more than 3 months and caused muscle involvement
and their VAS was less than 3, which means it was not an acute problem.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
spinal cord tumor
infection or fracture
infectious, vascular, endocrine, metabolic or neoplastic autoimmune disease, systemic disease, fibromyalgia, cauda equina syndrome,
previous spine surgery or lower extremity musculoskeletal injuries, previous experience in myofascial therapy or Do not have a history of rehabilitation treatment for back pain in the last two months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Panniculitis affecting regions of neck and back, lumbar region</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 groIntervention group: The interventions performed in this group include the release of spinal fascia such as quadratus lumborum, erector spinae, thoracolumbar fascia and soas for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed.</i_keyword>
      <i_keyword>Intervention grouIntervention group: The interventions performed in this group include the release of lower limb fascia such as gastrocnemius, soleus, plantar fascia, and hamstring for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed.p:</i_keyword>
      <i_keyword>Control group: routine electrotherapy is performed in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle thickness. Timepoint: The first session and the last session. Method of measurement: sonography.</prim_outcome>
      <prim_outcome>Pain. Timepoint: The first session and the last session. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Disability. Timepoint: The first session and the last session. Method of measurement: The Quebec Back Pain Disability Scale.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-10</approval_date>
        <contact_name>Ethics Comitee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Basij Blvd.,Semnan., Semnan Province semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
