<?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>IRCT20241110063656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-11</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of effect of strengthening exercises and core stability exercises on lumbopelvic rhythm and disability among patients with low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of strengthening exercises and core stability exercises on lumbopelvic kinematic and disability while lifting among patients with non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study will be conducted randomly using block randomization method.
Steps of block randomization:
1-Block Design:
First, the blocks are designed. For each block size (in this study we have 3 groups and we consider the block size to be 3) we create all possible states.
Initially, random blocks consisting of 3 groups are designed in different allocation orders, which include 6 different modes:
{Control, Stability, Strengthening}
{Control, Strengthening, Stability}
{Stability, Control, Strengthening}
{Stability, Strengthening, Control}
{Strengthening, Control, Stability}
{Strengthening, Stability, Control}
 2. Allocation of participants:
Then, one of the above blocks will be randomly selected by lottery. We then determine the allocation of the intervention or treatment to the groups based on the order in that block.
For example, if your chosen block is {Control, Stability, Strengthening}, then the first participant will be assigned to the control group, the next two participants will be assigned to the stability and strengthening group, and this will continue until all the people are assigned to the groups, Blinding description: This study is single-blinded. The assessor which in this study is the researcher, does the assessment of patients before and after the intervention. She's not aware of the group that each patient is in. Also the data will be given to the analyzer as first, second and third group and she is not informed which groups are the intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Eight exercises will be done to increase strength, with a frequency of three sets of exercises per session and eighteen sessions under the supervision of a physiotherapist. These exercises are performed to increase the strength of the superficial muscles of the trunk and abdomen. To prevent injury, stretching exercises are performed before and after strength exercises for warming up and cooling down. Each session lasts one hour, every other day, and lasts for six weeks. Intervention 2: Second intervention group: Eight exercises to increase core stability will be done, with a frequency of three sets of exercises per session and eighteen sessions under the supervision of a physiotherapist. These exercises are performed to increase the stability of the deep muscles of the trunk and abdomen. To prevent injury, stretching exercises are performed before and after strength exercises for warming up and cooling down. Each session lasts one hour, every other day, and lasts for six weeks. Intervention 3: Control group:  does not receive any interventions.</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:
Data related to the main outcome such as tables of before and after of variables can be shared.

When:
Beginning of the access period will be six months after the results are published

To whom:
The data will be available to both researchers working in universities and people working in physiotherapy clinics.

Conditions:
Those conducting studies on the same topic, including systematic reviews, are allowed to request non-personally identifiable information.

Where to obtain:
Applicants can refer to the researcher, Tara Kasvatara, and tkesvatara@gmail.com address to receive the documents.

How to obtain:
The applicant can receive the information after verifying his/her identity and description of his/her study and providing valid academic documents about his/her study, one week after submitting the application.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tara Kesvat Ara</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19, Shahid Montazeri 6 Ave, 17 shahrivar Blvd, Semnan city</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3518793494</zip>
        <telephone>+98 918 371 1532</telephone>
        <email>tkesvatara@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tara Kesvat Ara</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19, Shahid Montazeri 6 Ave, 17 shahrivar Blvd, Semnan city</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3518793494</zip>
        <telephone>+98 918 371 1532</telephone>
        <email>tkesvatara@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients should be at least 18 and at most 45 years old.
The low back pain should have lasted for 12 weeks
The patients should experience at most 3 degrees of visual analogue scale of pain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>existing any medical situation that has contraindication with exercise therapy
If the patient experiences radicular symptoms while walking or everyday activities
If  the patient's BMI is over 25
If the patient experiences Sciatic nerve block, below knee and leg pain, feet paresthesia, movement loss or motor lesions in upper or lower extremities
If patient has acute disk hernia (according to MRI), surgery, spinal fracture or cancer
If the patient is pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Biomechanical lesion, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Eight exercises will be done to increase strength, with a frequency of three sets of exercises per session and eighteen sessions under the supervision of a physiotherapist. These exercises are performed to increase the strength of the superficial muscles of the trunk and abdomen. To prevent injury, stretching exercises are performed before and after strength exercises for warming up and cooling down. Each session lasts one hour, every other day, and lasts for six weeks.</i_keyword>
      <i_keyword>Second intervention group: Eight exercises to increase core stability will be done, with a frequency of three sets of exercises per session and eighteen sessions under the supervision of a physiotherapist. These exercises are performed to increase the stability of the deep muscles of the trunk and abdomen. To prevent injury, stretching exercises are performed before and after strength exercises for warming up and cooling down. Each session lasts one hour, every other day, and lasts for six weeks.</i_keyword>
      <i_keyword>Control group:  does not receive any interventions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability scale from Oswestry questionnaire. Timepoint: Before the intervention and six weeks after the beginning of intervention. Method of measurement: Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Lumbopelvic kinematic. Timepoint: Before the intervention and six weeks after the beginning of intervention. Method of measurement: Qualysis motion analysis.</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>2024-11-11</approval_date>
        <contact_name>Research Ethics Committee of Semnan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Semnan university of medical sciences, Basij Blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
