<?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>IRCT20220509054787N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-22</date_registration>
      <primary_sponsor>Deputy of Research and Technology</primary_sponsor>
      <public_title>The effects of 12 weeks supervised stabilization exercise on abdominal muscle thickness in patients with chronic low back pain: A single blind randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>"Comparative study of the effect of 12 weeks of monitored stability exercises combined with routine physiotherapy treatment with routine physiotherapy treatment alone on abdominal muscle size in patients with chronic non-specific back pain using ultrasonography"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63412</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the restricted randomization method randomization (block type randomization) block randomization (we will use. blocking usually in order Balance the number of samples assigned to each group To be used in the study. This feature helps researchers to Items that require intermediate analyzes during the sampling process The number of samples assigned to each of the case groups Study is equal. The size of all the blocks is equal and we are in this Two-group trial of 6 blocks (including 3 participants) We will have an intervention group and 3 participants in the control group. Randomization tools are also used in sequence generation software Random allocation software is used Random sequence generation software in addition to simple randomization capable To generate random sequences by block generation method. For hiding Allocation concealment (Allocation concealment) We use the method used to execute the sequence Random refers to study participants, in a way That before the individual is assigned, the assigned group is not specified. With From opaque envelopes sealed in random sequence که در (Sequentially numbered, sealed, opaque envelopes) This method uses each of the random sequences created on a card It is registered and the cards are placed in the letter envelopes in order To be. In order to maintain a random sequence, also on the outer surface of the envelope The numbering is done in the same way. Finally the envelope lid The letters are pasted and placed in a box, respectively. At Time to start registration of participants, based on the order of entry of the company Eligible applicants to open one of the envelopes in order And the assigned group of the participant will be revealed, Blinding description: "Ultrasound evaluation is performed by a radiologist with 15 years of experience and a faculty member who had no knowledge of how to group patients.".</study_design>
      <phase>N/A</phase>
      <hc_freetext>LOW BACK PAIN.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Lumbar stabilization exercises consisted of 14 exercises that are performed with the aim of strengthening the deep lumbar stabilizing muscles (TrA, EO and IO). All 14 stabilization exercises will be performed once, in a row and in the same order. Before each exercise, the physiotherapist provides detailed oral explanations and visual instructions (images) about the start and end position. The training program will be applied to the knees in a four-point position using abdominal fire. Patients were asked to perform 10 exercise programs per session, three times a day (one in the clinic and two at home) for three sessions per week. In order for the number and frequency to be the same, each exercise will be performed ten times in the first session, and all patients were asked to refrain from strenuous physical activity during the treatment period. Intervention 2: Control group: Patients in the experimental group (n = 30) will receive routine physiotherapy and supervised stabilization exercises performed by an experienced independent 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health, Golestan University of Medical Sciences, Gorgan, Iran »</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3245 4340</telephone>
        <email>sophiajavad@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health, Golestan University of Medical Sciences, Gorgan, Iran</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3245 4310</telephone>
        <email>sophiajavad@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic low back pain of both sexes (between 20 and 55 years)
Patients with low back pain for which no specific cause has been reported by the treating physician in clinical examinations and radiography
Low back pain lasts for 12 weeks or more
4- Enjoying public health</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of numbness and decrease in muscle strength or possibly lack of urine control, which indicates the presence of horsetail syndrome
History of spine surgery
Pain in the spine area with Wellers fever, morning dryness, etc., which indicate the presence of infectious sponidopathy syndrome, malignancy, or inflammatory diseases, sponidylosis
Presence of pressure fracture due to osteoporosis, spinal stenosis and spondylolysis or spondylolistosis, presence of fracture in the spine which indicates the presence of osteoporosis or other diseases .
Pregnancy</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:  Lumbar stabilization exercises consisted of 14 exercises that are performed with the aim of strengthening the deep lumbar stabilizing muscles (TrA, EO and IO). All 14 stabilization exercises will be performed once, in a row and in the same order. Before each exercise, the physiotherapist provides detailed oral explanations and visual instructions (images) about the start and end position. The training program will be applied to the knees in a four-point position using abdominal fire. Patients were asked to perform 10 exercise programs per session, three times a day (one in the clinic and two at home) for three sessions per week. In order for the number and frequency to be the same, each exercise will be performed ten times in the first session, and all patients were asked to refrain from strenuous physical activity during the treatment period.</i_keyword>
      <i_keyword>Control group: Patients in the experimental group (n = 30) will receive routine physiotherapy and supervised stabilization exercises performed by an experienced independent physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal muscle thickness (TrA; IO; EO). Timepoint: Before and after the intervention. Method of measurement: ultrasongraphy.</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>Deputy of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Ethics committee of golestan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Health, Golestan University of Medical Sciences, Gorgan, Iran » gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
