<?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>IRCT20090228001719N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Diaphragmatic Breathing Exercise on improving of Chronic Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Diaphragmatic Breathing Exercise on Pain, Balance and Function in athletes with Chronic Non-specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49690</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were selected by simple randomization from athletes with low back pain based on inclusion criteria, then samples were asked randomly select a piece of paper among 20 papers that was written on control group or breathing exercise group (10 control group and 10 breathing exercise group), Blinding description: The person evaluating the outcome measures  did not know the type of treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patients in the breathing exercise group also came on the clinic three days a week for four weeks. In each session, the patients received electrotherapy treatment same as control group. In addition to patients were required to perform two types of breathing exercises daily for 4 weeks. These breathing exercises were taught to the patient at the beginning of each week by the physiotherapist and practiced with him to ensure that the exercise was performed correctly. It lasted 5 minutes and was done twice a day, and considering that there were two types of exercises per day (days and times that did not go to the clinic at home), a total of 20 minutes a day. When patients went to the physiotherapy clinic, one set of these breathing exercises was performed with the therapist after electrotherapy. Exercises for each week are as follows:                  First week: Supine breathing+ Crocodile breathing       Second week: Supine breathing+ Crocodile breathing  with Theraband      Third week: Seated Breathing+ 90/90/90 Breathing          Forth week: Seated Breathing+ 90/90/90 Breathing  with Theraband.     Outcomes were measured before treatment and after 4 weeks of treatment. They received a total of 12 sessions of physiotherapy. Intervention 2: Control group: In this group, the patients came on the clinic 4 weeks , every weeks 3 days with every other day and received  TENS and Interferential. In each session the  patients received  30 minutes of conventional TENS with a pulse duration of 100 microseconds and 20 minutes of Interferential with a base frequency of 4000 Hz and a variable frequency of 50 to 100 Hertz . Outcomes were measured before treatment and after 4 weeks of treatment. There was no exercise therapy in this group. They received a total of 12 sessions of physiotherapy.</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:
Only information about the effect of treatment on outcomes will be made available to faculty and students through the publication of articles and dissertations.

When:
After paper publishing

To whom:
Teachers, students, patients

Conditions:
No condition

Where to obtain:
My e-mail

How to obtain:
Sending message to my e-mail with specific cause of request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadijeh Otadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich- e- Shemiran, Faculty of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1366718661</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>k_otadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Otadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich- e-Shemiran, Faculty of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1366718661</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>k_otadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with nonspecific low back pain
Age between 20 to 50
Training at least 3 times a week for a total of 6 hours
History of back pain for more than 12 weeks (chronic back pain)
Pain between  3 to 7 based on VAS( visual analogue scale)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other musculoskeletal or neurological disorders
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pain syndrome</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 patients in the breathing exercise group also came on the clinic three days a week for four weeks. In each session, the patients received electrotherapy treatment same as control group. In addition to patients were required to perform two types of breathing exercises daily for 4 weeks. These breathing exercises were taught to the patient at the beginning of each week by the physiotherapist and practiced with him to ensure that the exercise was performed correctly. It lasted 5 minutes and was done twice a day, and considering that there were two types of exercises per day (days and times that did not go to the clinic at home), a total of 20 minutes a day. When patients went to the physiotherapy clinic, one set of these breathing exercises was performed with the therapist after electrotherapy. Exercises for each week are as follows:                  First week: Supine breathing+ Crocodile breathing       Second week: Supine breathing+ Crocodile breathing  with Theraband      Third week: Seated Breathing+ 90/90/90 Breathing          Forth week: Seated Breathing+ 90/90/90 Breathing  with Theraband.     Outcomes were measured before treatment and after 4 weeks of treatment. They received a total of 12 sessions of physiotherapy.</i_keyword>
      <i_keyword>Control group: In this group, the patients came on the clinic 4 weeks , every weeks 3 days with every other day and received  TENS and Interferential. In each session the  patients received  30 minutes of conventional TENS with a pulse duration of 100 microseconds and 20 minutes of Interferential with a base frequency of 4000 Hz and a variable frequency of 50 to 100 Hertz . Outcomes were measured before treatment and after 4 weeks of treatment. There was no exercise therapy in this group. They received a total of 12 sessions of physiotherapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and after 4 weeks of treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Before and after 4 weeks of treatment. Method of measurement: Unilateral Hip Bridge Endurance.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before and after 4 weeks of treatment. Method of measurement: Star balance test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-06</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Seiences</contact_name>
        <contact_address>Keshavarz Blv, Qudes Sreet Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
