<?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>IRCT20211018052801N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-17</date_registration>
      <primary_sponsor>Vice President of Research and Technology of Bu-Ali Sina university of Hamedan</primary_sponsor>
      <public_title>Effect of physical exercises and psychological exercises in chronic back pain</public_title>
      <acronym>DNS</acronym>
      <scientific_title>Comparison of physical exercises with physical exercises and psychological exercises on pain, range of motion, lower extremity strength. Quality of life and Kinesiophobia in the elderly with chronic back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups, Feldenkrais and DNS combined exercises group and DNS exercise group by Random Number Generator. This method ensures that each participant has an equal chance of being assigned to either group, reducing selection bias, Blinding description: Due to the nature of the therapeutic exercise and evaluation, athletes will not be able to do it, but the participants and one of the researchers who will evaluate will measure after eight weeks, they will be assigned to groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Combined Feldenkrais and dynamic neuromuscular stabilization exercises. Intervention 2: Intervention group: Dynamic neuromascular stabilization.</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:
Files related to the information measured in the pre-test and post-test

When:
Access is possible after the articles related to the research plan are published.

To whom:
Students and specialists in the field of sports rehabilitation and injury prevention are allowed access.

Conditions:
There will be no analysis of the data for others.

Where to obtain:
Refer to the authors of the research plan.

How to obtain:
This is possible by receiving permission from the National Science Foundation of Iran.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Blvd., Hamedan.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 918 850 3783</telephone>
        <email>F_Saki@basu.ac.ir</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marziyeh Ziya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Blvd., Hamedan.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 916 279 4207</telephone>
        <email>marziyeziyaaa@yahoo.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low back pain in the range of 2-5 out of 10 on the Numerical Pain Rating Scale (NPRS)
History of back pain for more than three months
Non-use of auxiliary equipment
No history of cardiovascular diseases and respiratory problems
No history of fractures and severe injuries in the lower limbs and spine
Non-participation in therapeutic interventions during the last 4 weeks
Voluntary participation in research
Independence in daily activities</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any respiratory disease, pregnancy or history of surgery in the lumbar region
Inability to exercise
Occurrence of pain during the training protocol
Obvious abnormality that is problematic for the implementation of research
Body mass index (BMI) greater than 30</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: Combined Feldenkrais and dynamic neuromuscular stabilization exercises.</i_keyword>
      <i_keyword>Intervention group: Dynamic neuromascular stabilization</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session). Method of measurement: Using Visual Analogue Scale of pain intensity.</prim_outcome>
      <prim_outcome>Lumbar range of motion. Timepoint: Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session). Method of measurement: Modified -Modified Schober's Test.</prim_outcome>
      <prim_outcome>Lower limp strength. Timepoint: Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session). Method of measurement: 30 Seconds Sit To Stand Test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session). Method of measurement: 36-Item Short Form Survey Instrument.</prim_outcome>
      <prim_outcome>Kinesiophobia. Timepoint: Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session). Method of measurement: Tempa scale.</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>Iran National Science Foundation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-28</approval_date>
        <contact_name>Ethics committee of Bu-Ali Sina university oh Hamedan</contact_name>
        <contact_address>Bu-Ali Sina university oh Hamedan, Shahid Ahmadi Roshan Avenue, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
