<?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>IRCT20190311043012N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-18</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>assessment the thickness of multifidus muscles activity before and after one session dry needling in patient with  low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Ultrasonographic evaluation thickness of Multifidus muscles before and immediately after dry needling in non- specific low back pain patients in comparison sham group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants are blind to the type of intervention, that way in sham group, the needle is moved only on the skin and the needle does not actually enter  the multifidus.the main investigator is blind to the type of intervention of each participant, so that main investigator uses the assistant to intervene.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First intervention group:  non-specific low back pain volunteers, with real dry needle therapy. In this one session technique,  needles with sizes 0.30 ~ 50 mm or 0.30 ~ 60 mm are used according to the size of the  muscle participant. In this technique, the patient is lying down and inserted the sterile needle into the muscle of the multifidus at the L4-L5 or L5-S1 levels. needle is placed approximately 1.5 cm next to spinous proces vertically at the desired surface. After punching the surface of the skin, the needle toward the multifidus and lumbar vertebral lamina.oriented downward and inward (approximately 20 °). Intervention 2: Control group: nonspecific low back pain volunteers without insertion of needle(sham).In this technique, like intervention group, the patient is prone and the needle contacts the skin without insert to the muscle.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pooran Madani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabatabaee clinic, Mashahir square,Blvd Ghods</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35196-98375</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>Pooran.madani@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rosita Hedayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences,Complex of university,5 Km of Damghan Road,Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>983519899951</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>Rosehed@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18 to 45 years
Having  back pain for a period of three months ago or more
Pain in the region between the margin of the costa up to the top of the lower fold of the gluteal region
Pain intensity below 3 based on visual pain scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any symptoms of serious spinal cord involvement
Symptoms of cauda equina Syndrome
Symptoms of spinal canal stenosis
Symptoms of Nerve root involvement
Spinal manipulation
Fear of the needle
stabilization exercise in the lumbar multifidus muscles during the last 4 weeks
any signs and symptoms of a pathology (cancer, infection, etc.)
history of any coagulation problems or taking anti-clot drugs
pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M95-M99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First intervention group:  non-specific low back pain volunteers, with real dry needle therapy. In this one session technique,  needles with sizes 0.30 ~ 50 mm or 0.30 ~ 60 mm are used according to the size of the  muscle participant. In this technique, the patient is lying down and inserted the sterile needle into the muscle of the multifidus at the L4-L5 or L5-S1 levels. needle is placed approximately 1.5 cm next to spinous proces vertically at the desired surface. After punching the surface of the skin, the needle toward the multifidus and lumbar vertebral lamina.oriented downward and inward (approximately 20 °).</i_keyword>
      <i_keyword>Control group: nonspecific low back pain volunteers without insertion of needle(sham).In this technique, like intervention group, the patient is prone and the needle contacts the skin without insert to the muscle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lumbar Multifidus muscle rest thickness. Timepoint: Measuring the thickness of the multifidus Before,immediately after and 10 days after the end of intervention. Method of measurement: ultrasonography setting.</prim_outcome>
      <prim_outcome>Thickness of submaximal contraction mode of the lumbar Multifidus muscle. Timepoint: Measuring the thickness of the multifidus Before,immediately after and 10 days after the end of intervention. Method of measurement: ultrasonography setting.</prim_outcome>
      <prim_outcome>Muscle thickness changes of lumbar Multifidus. Timepoint: Measurement of thickness changes of the multifidus Before,immediately after and 10 days after  end the intervention. Method of measurement: ultrasonography setting.</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>2019-02-19</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Tabatabaee clinic, Mashahir square, Blvd ghods semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
