<?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>IRCT20180714040466N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of walking on postural reactions in patients with low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of walking on postural reactions, pain and disability in patients with non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70454</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the number of patients in each group,the particular sort of treatment( The electrotherapy treatment group and routine physiotherapy exercises or the electrotherapy routine treatment group includes physiotherapy along with walking exercises on the treadmill, including walking forward, walking backwards and walking sideways) is written on a piece of paper.Each paper is placed in a sealed envelope.One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that.If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Electrotherapy includes 20 minutes of TENS, 20 minutes of infrared, stretching and strengthening exercises, and active free exercise for lumbosacral. The total duration of a physiotherapy session will be one hour. It will last three days a week for six weeks. Intervention 2: Intervention group: In addition to the treadmill walking routine, it will include walking forward, walking backward, and walking sideways. First, the exercise period will start with ten minutes of walking forward. Then, every week, walking backwards and walking to the sides will be added for five minutes, so that in the fifth week of the research, the total time of walking on the treadmill will be thirty-five minutes and will be done in all directions.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al anbia Hosp, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al anbia Hosp, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Years: Range:18-45, males and females
Chronic back pain in the area between the twelfth rib and the rump without reference to the lower limbs, which has lasted for more than three months and has no specific cause and has caused problems in performance and physical disability and has not subsided.
People with a desire to enter the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of neurological disorder
Rheumatic  diseases
Cancer
Spinal cord lesions
History of surgery
Structural injuries of the spine
Pregnancy
History of therapeutic exercise in the last 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dorsalgia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Electrotherapy includes 20 minutes of TENS, 20 minutes of infrared, stretching and strengthening exercises, and active free exercise for lumbosacral. The total duration of a physiotherapy session will be one hour. It will last three days a week for six weeks.</i_keyword>
      <i_keyword>Intervention group: In addition to the treadmill walking routine, it will include walking forward, walking backward, and walking sideways. First, the exercise period will start with ten minutes of walking forward. Then, every week, walking backwards and walking to the sides will be added for five minutes, so that in the fifth week of the research, the total time of walking on the treadmill will be thirty-five minutes and will be done in all directions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-Overall static stability index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Anterior-posterior static stability index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Internal and external static stability index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Overall dynamic stability index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Anterior-posterior dynamic stability index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Stability index of internal and external dynamics. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Biodex device.</prim_outcome>
      <prim_outcome>Pain intensity index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: VAS questionnaire.</prim_outcome>
      <prim_outcome>Disability severity index. Timepoint: The beginning of the study (before the start of the intervention) and the end of the 6-week treatment period. Method of measurement: Oswestry Questionnaire.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-08</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hesabi Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
