<?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>IRCT20220117053752N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-05</date_registration>
      <primary_sponsor>Islamic Azad University, Science and Research Branch, Tehran</primary_sponsor>
      <public_title>The effect of a workout with a pelvic clock tool  on central muscle endurance, torso range of motion and pain intensity in middle-aged women with nonspecific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a workout with a pelvic clock tool on central muscle endurance, torso range of motion and pain intensity in middle-aged women with nonspecific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63604</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: RA simple randomization method was used to assign individuals to two groups, which was done by coin tossing method. This method is usually used to create a random sequence in two-group experiments in such a way that one of the study groups considers the lion and the other group the line, and based on the sample size, coins were tossed and Individuals are assigned to two random groups. In order to make it clear that before allocating people to two groups, it is not clear to which group individuals will be assigned, or in other words, hiding the random allocation (Allocation concealment) by the method of opaque envelopes sealed with sequentially randomized sequence (Sequentially numbered, sealed opaque envelopes) was used. This method is one of the common methods in concealing random allocation, which is abbreviated to SNOSE method. In this method, after a random sequence, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The training protocol of the present study is derived from Pilates exercises, the movements of which are performed on a sports mat. The exercises include 18 movements of Pilates exercises (the protocol consists of three parts: 1- Ten stretching exercises for the pelvis and back 2- Two stretching exercises for the direction of the body 3- Six exercises for central body stability). Exercises are performed for eight weeks (3 sessions of 45 minutes per week) under the supervision of a doctor. The intensity of the exercises is based on increasing the subject's ability to perform the exercises while keeping the body in line and without feeling pain. The equipment used to perform the exercises includes a sports mat and a compressed foam. Intervention 2: Control group:.</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 data can be shared after identifying individuals.

When:
All data can be shared after identifying individuals.

To whom:
Researchers working in academic and scientific institutions

Conditions:
After identifying the participants, all the data can be made available to researchers, and any other analysis of the data and any use for research and therapeutic purposes of this study is allowed

Where to obtain:
Islamic Azad University, Research Sciences Branch, Department of Physical Education. Forough Sepiddar-
  Contact number 09195901181
Email: Sepidar1181@gmail.com

How to obtain:
After receiving the message from the applicant and reviewing the application conditions, the required information will be sent to the person at the earliest opportunity.

Comments:
I do not have</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valenjac_ Daneshjou Blvd_ Shahid Beheshti University</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5845</telephone>
        <email>ahbarati20@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhossein Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valenjac_ Daneshjou Blvd_ Shahid Beheshti University</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5845</telephone>
        <email>ahbarati20@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nonspecific back pain that is at least 3 months old
Age over 40 years and under 50 years
No history of radicular pain and any neurological symptoms, systemic infection, cardiovascular and balance disorders
Not pregnant
No history of metabolic, systemic, inflammatory, rheumatic and malignant diseases</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of a history of recent trauma and fracture and recent lower limb injury
Existence of obvious instability in the lumbar region
History of spinal surgery and deformity or severe spinal disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The training protocol of the present study is derived from Pilates exercises, the movements of which are performed on a sports mat. The exercises include 18 movements of Pilates exercises (the protocol consists of three parts: 1- Ten stretching exercises for the pelvis and back 2- Two stretching exercises for the direction of the body 3- Six exercises for central body stability). Exercises are performed for eight weeks (3 sessions of 45 minutes per week) under the supervision of a doctor. The intensity of the exercises is based on increasing the subject's ability to perform the exercises while keeping the body in line and without feeling pain. The equipment used to perform the exercises includes a sports mat and a compressed foam.</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endurance of the muscles of the central part of the body. Timepoint: Before and after interventions. Method of measurement: McGill Tests.</prim_outcome>
      <prim_outcome>Range of motion of the trunk. Timepoint: Before and after interventions. Method of measurement: modified-modified Shober's technique.</prim_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before and after interventions. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscular strength of torso extensions. Timepoint: Before and after interventions. Method of measurement: Nicholas handheld dynamometer.</sec_outcome>
      <sec_outcome>Proprioception Functional. Timepoint: Before and after interventions. Method of measurement: Universal Goniometer in method Newcomer.</sec_outcome>
      <sec_outcome>Movement Control Ability. Timepoint: Before and after interventions. Method of measurement: Luomajoki Motion Control Tests.</sec_outcome>
      <sec_outcome>Static balance. Timepoint: Before and after interventions. Method of measurement: BESS test.</sec_outcome>
      <sec_outcome>Dynamic balance. Timepoint: Before and after interventions. Method of measurement: Star test.</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>Islamic Azad University, Science and Research Branch, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-22</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Science and Research Branch</contact_name>
        <contact_address>Tehran: Ekbatan Phase 2, Block 3, Entrance 6, Unit 122 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
