<?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>IRCT20221006056105N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-11</date_registration>
      <primary_sponsor>The University Of Faisalabad</primary_sponsor>
      <public_title>Effects Of Pilates Exercises For  Non-specific Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects Of Pilates Exercises As A Treatment Approach In Patients With Non-specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used for randomization was chit and draw method. In this method, chits are prepared and assigned some numbers then they are randomly drawn to allocate participants in either of the two groups. Randomization was used to avoid biasness, Blinding description: The participants were blinded in the study so that they did not know in which they were sent into. Blinding was done in order to avoid placebo effect. The participants were unaware  of the treatmenr protocol given in both groups.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Non-specific Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: The participants of experimental/interventional group received hot pack as baseline treatment then performed Pilates exercises as treatment adjunct for 4 weeks of duration, 2 sessions per week. Measurements of pain intensity, lumbar range of motion were recorded at first and last session with measuring tools. The Pilates exercises program included Diaphragmatic breathing (as a warm up, slowly inhale and exhale as much as the patient could perform), The hundred (4 reps, 30 secs each), Roll up (5 reps, 30 secs), Spine stretch (5 reps with 2 minutes of recovery period within each rep), Single leg circles (5 reps each leg), Single leg circles with bent leg (5 reps for each leg), Single leg stretch (5 reps for each leg) and Diaphragmatic breathing ( to cool down the patient). Intervention 2: The participants of control group recieved hotpack as the baseline treatment and then they were instructed to continue their activities of daily living for 4 weeks, 2 sessions per week.</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 there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Salahuddin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P 175, Shadman Town, Sargodha Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 337 7002916</telephone>
        <email>hashmisaman88@gmai.com</email>
        <affiliation>Madinah Teaching Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saman Salahuddin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P 175 Shadman Town Sargodha Road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 337 7002916</telephone>
        <email>hashmisaman88@gmail.com</email>
        <affiliation>Madinah Teaching Hospital Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>LBP that has proceeded longer than 3 months
Male and female participants aging between 30-50 years
Participants having complain of 3 to 7 score on NPRS
No leg symptoms in last week
No recent surgery in past 6 months</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy (all trimesters)
Any history of spinal fracture
Participants having pain due to other pathology (diagnostic triage for LBP)
Ankylosing Spondylitis
Participants enrolled in regular exercise programs</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>The participants of experimental/interventional group received hot pack as baseline treatment then performed Pilates exercises as treatment adjunct for 4 weeks of duration, 2 sessions per week. Measurements of pain intensity, lumbar range of motion were recorded at first and last session with measuring tools. The Pilates exercises program included Diaphragmatic breathing (as a warm up, slowly inhale and exhale as much as the patient could perform), The hundred (4 reps, 30 secs each), Roll up (5 reps, 30 secs), Spine stretch (5 reps with 2 minutes of recovery period within each rep), Single leg circles (5 reps each leg), Single leg circles with bent leg (5 reps for each leg), Single leg stretch (5 reps for each leg) and Diaphragmatic breathing ( to cool down the patient).</i_keyword>
      <i_keyword>The participants of control group recieved hotpack as the baseline treatment and then they were instructed to continue their activities of daily living for 4 weeks, 2 sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Numeric Pain Rating Scale. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: It is a  subjective 10 point pain assessment scale that a person describes according to his/her pain intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Modified Schober Test. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: It is a test used to measure lumbar flexion and extension. A line was drawn 5 cm below and 10cm above the level of posterior superior iliac spine and the patients were instructed to forward flex and touch the toes, the measurements were taken using a measuring tape.</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>The University Of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-19</approval_date>
        <contact_name>Ethics Committee Of The University Of Faisalabad</contact_name>
        <contact_address>Sargodha Road, University Town, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
