<?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>IRCT20200215046499N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dry needling technique of iliopsoas muscle</public_title>
      <acronym></acronym>
      <scientific_title>The effect of iliopsoas muscle dry needling technique on the clinical symptoms of subject with non-specific low back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by someone outside the research team with a 1:1 parallel allocation method, which uses a computer randomization program to assign participants to groups, using blocks of four and six. Then he uses opaque sealed envelopes and hides the allocation of groups with the method pre-labeled with the letters A and B.) They will be placed in two control and intervention groups, Blinding description: Double-blind, participants: In the control group, patients are told that routine physical therapy is the only treatment.
Outcome assessor: The person who assesses the patients does not know whether they belong to the control or intervention group
  Data analyst: The person who evaluates the data of the two groups does not know whether they belong to the contr.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific low back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving dry needling during 6 sessions (with a sterile dong bang needle with a size of 30*50 mm), they are included in the conventional physiotherapy treatment provided by the physiotherapist. People in the intervention group of the conventional treatment (as a modality It is possible to use continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 for 6 minutes (same side of the waist), using a burst TENS electric current with a frequency of 2 Hz and a diversion of 100 µs for 20 minutes, and using a hot pack simultaneously with the current. Also, sports exercises designed in the clinic are taught to the person under the supervision of a physiotherapist. Intervention 2: Control group: People in the control group received conventional treatment (as a modality, continuous ultrasound with a frequency of 1 MHz and intensity of 1.5 for 6 minutes (same side of the back), use of TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes and using The hot pack is applied simultaneously with the current (76).Also, the person is taught the designed sports exercises in the clinic under the supervision of the physiotherapist.</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 decided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hakimeh adigozali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Adigozalih@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hakimeh Adigozali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 51 6661 6471</telephone>
        <email>Adigozalih@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People between 30 and 65 years old
Chronic back pain that lasts for 3 months or more
People with a disability score of &gt;40 in the QBPDS Questionnaire)
Not receiving any other physiotherapy treatment while participating in the study
The presence of a trigger point in the muscle Iliposoas</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with sensory and/or coagulation disorders
History of spine surgery
Heart complications
Simultaneous severe disease of the central or peripheral nervous system, Epilepsy
Needle phobia
Serious pathologies
Specific back pain (for example, the presence of spinal canal stenosis, spondylolisthesis, tumors, etc.)
People who have contraindications for transcutaneous electrical stimulation (TENS) and (US) will be excluded</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>Intervention group: In addition to receiving dry needling during 6 sessions (with a sterile dong bang needle with a size of 30*50 mm), they are included in the conventional physiotherapy treatment provided by the physiotherapist. People in the intervention group of the conventional treatment (as a modality It is possible to use continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 for 6 minutes (same side of the waist), using a burst TENS electric current with a frequency of 2 Hz and a diversion of 100 µs for 20 minutes, and using a hot pack simultaneously with the current. Also, sports exercises designed in the clinic are taught to the person under the supervision of a physiotherapist</i_keyword>
      <i_keyword>Control group: People in the control group received conventional treatment (as a modality, continuous ultrasound with a frequency of 1 MHz and intensity of 1.5 for 6 minutes (same side of the back), use of TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes and using The hot pack is applied simultaneously with the current (76).Also, the person is taught the designed sports exercises in the clinic under the supervision of the physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity of trigger points. Timepoint: Before and after intervention. Method of measurement: Algometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain intensity of back. Timepoint: Before and after intervention. Method of measurement: Numeric pain rating scale (NPRS).</sec_outcome>
      <sec_outcome>Intensity of depression and anxiety. Timepoint: Before and after intervention. Method of measurement: Hospital Anxiety and Depression Scale( HADS).</sec_outcome>
      <sec_outcome>Intensity of functional disability. Timepoint: Before and after intervention. Method of measurement: Quebec back pain disability scale(QBPDS).</sec_outcome>
      <sec_outcome>Pain pressure threshold of trigger points. Timepoint: Before and after intervention. Method of measurement: Algometer.</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>Tabriz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-04</approval_date>
        <contact_name>Ethics committee of Tabriz University of medical sciiences</contact_name>
        <contact_address>Faculty of Rehabilitation sciences, Tabriz University of medical sciences,29 Bahman Blvd, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
