<?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>IRCT20240504061646N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-11</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparing Two Physical Therapy Techniques to Relieve Lower Back Pain</public_title>
      <acronym>PNF &amp; MET</acronym>
      <scientific_title>Comparative Effects of Proprioceptive Neuromuscular Facilitation and Muscle Energy Technique of Iliopsoas Muscle on Non-Specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Consecutive Random Sampling
Unit of Randomization: Individuals
Randomization Strata: no stratification needed, population was homogenous, (only female patients, having non-specific Low Back Pain, in Physical Therapy Outpatient Department  of Allied Hospital Faisalabad
Further division in groups: 
Tool: online randomization Generator
How the Random sequence was built: using Online randomization generator, a list was obtained with 44 sample size dividing equally into two groups, Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation.
according to list, very first patients received the assigned treatment ( as written in the list) and so on, Blinding description: Study was single blinded. participants did not know about two different treatments being given to two separate groups. it was quite easy to carry out and maintain single blindness, as no tool was used for different treatment groups. desired treatments were manual.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-Specific Low Back Pain (having tightened Iliopsoas).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Muscle Energy Technique (post-isometric Relaxation). Intervention 2: Intervention group: Proprioceptive Neuromuscular Facilitation (hold-relax D1 Flexion-Extension Pattern).</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 need for sharing</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rozina Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 27E, madina street, near Heaven banglows, Muslim town 1, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 7599550</telephone>
        <email>rozinanaz93@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rozina Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 27E, madina street, near Heaven banglows, Muslim town 1, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 7599550</telephone>
        <email>rozinanaz93@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-specific low back pain
Have pain for past one month
Thomas test positive
Numeric Pain Rating Scale &gt; 3
Hip Extension Range of Motion &gt;10
Oswestry Disability Index Mild disability  (5-24)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>•	Carcinomas or tumors anywhere
•	Anatomical or chest wall deformities
•	Pregnant female
•	Severe Osteoporosis
•	Numeric Pain Rating Scale &gt; 8
•	Hip Extension Range of Motion&gt; 40 (Hypermobility)
•	Oswestry Disability Index score &gt; 24
•	Past surgical history of thoracic or lower spine
•	Infections, Acute Inflammations
•	Unbearable sharp pain at joints when performing movements
•	Wear and tear to soft tissues or hematoma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M.54.9</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: Muscle Energy Technique (post-isometric Relaxation)</i_keyword>
      <i_keyword>Intervention group: Proprioceptive Neuromuscular Facilitation (hold-relax D1 Flexion-Extension Pattern)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary Outcome Measure: Pain , Hip Extension Range. Timepoint: At baseline (day 1st, Before treatment), Post- treatment day 1st, Post-treatment day 2nd, post-treatment day 3rd. Method of measurement: Numeric Pain Rating Scale for pain level, a scale was used to measure pain. Goniometer to measure Range of motion of hip extension bilaterally.</prim_outcome>
      <prim_outcome>Level of Disability. Timepoint: pre-treatment day1st, Post-treatment day 3rd. Method of measurement: Oswestry Disability Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain, Hip Extension Range. Timepoint: pre treatment day 1st, post treatment day 1st, post treatment day 2nd, post treatment day 3rd. Method of measurement: Numeric Pain Rating Scale and Goniometer.</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>2024-01-01</approval_date>
        <contact_name>Ethical Committee of The University of Faisalabad</contact_name>
        <contact_address>House no. 27E, madina street, near Heaven banglows, Muslim town 1, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
