<?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>IRCT20200423047173N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-16</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Effect of myofascial release on low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of  lumbar and lower limbs posterior superficial backline  myofascial release on elastic coefficient, thickness and pain  in non-specific chronic low back pain patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50558</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In the present study, patients (in two groups of myofascial lumbar and lower limb release) and co-evaluator who performs ultrasound before and after the intervention, will be unaware of the patient's exposure (myofascial lumbar or lower limb).</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Myofascial release of lumbar region in patients with chronic nonspecific low back pain. Intervention 2: Intervention group 2: Myofascial release of posterior-superficial pathway of lower extremities in patients with chronic nonspecific low back pain. Intervention 3: Control group: Routine physiotherapy (ultrasound and tens) of the lumbar region in patients with nonspecific low back pain.</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 potential data can be shared after unidentified individuals

When:
Access period starts 12 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
In order to perform any kind of analysis on the data, coordination is required

Where to obtain:
Send a message to the mentioned e-mail address, named Hassan Tamratash.
h.tamartash@modares.ac.ir

How to obtain:
After sending the message and making the necessary arrangements, the data will be sent for a maximum of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Tamartash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3819</telephone>
        <email>h.tamartash@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Tamartash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3819</telephone>
        <email>h.tamartash@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with chronic nonspecific low back pain with a history of at least 12 months of low back pain.
Shortness in lumbar myofascial and posterior-superficial pathway of lower extremity myofascia.
Having a pain score between 4 and 6 on the VAS pain scale
Body mass index between 18.5 and 30.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spine and lower limb surgery
Existence of major deformities in the spine such as: scoliosis, kyphosis, etc.
Infection and history of rheumatic, infectious, cardiovascular diseases, etc.
Psychopathy
Disorders of the vestibular and visual systems.
Taking corticosteroids and history of lumbar injections (oral or steroid injections).
Pregnancy
Perform intense physical activity during the study.
Inability and unwillingness to continue study.</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Myofascial release of lumbar region in patients with chronic nonspecific low back pain</i_keyword>
      <i_keyword>Intervention group 2: Myofascial release of posterior-superficial pathway of lower extremities in patients with chronic nonspecific low back pain</i_keyword>
      <i_keyword>Control group: Routine physiotherapy (ultrasound and tens) of the lumbar region in patients with nonspecific low back pain</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lumbar fascia elastic coefficient. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Ultrasound device.</prim_outcome>
      <prim_outcome>Lumbar muscles elastic coefficient. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Ultrasound device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cuff and hamstring muscle flexibility. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Goniameter.</sec_outcome>
      <sec_outcome>Lumbar pain. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Visual analoge scale.</sec_outcome>
      <sec_outcome>Pelvic rotation angle. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Inclinometer.</sec_outcome>
      <sec_outcome>Lumbar flexion angle. Timepoint: The beginning of the study, the end of the second week, the end of the fourth week. Method of measurement: Flexible ruler.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-07</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
