<?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>IRCT20210112050014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-10</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effect of radial extracorporeal shockwave therapy for sciatic pain with disc herniation</public_title>
      <acronym>rESWT trial</acronym>
      <scientific_title>Effect of radial extracorporeal shockwave therapy for sciatic pain with disc herniation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, Randomization description: Randomization done through the computer generated system on openEpi website for sample size calculation, Blinding description: In this study patient will be blind. He/ she is not the one who will choose the treatment by themselves voluntarily. Treatment option will be written on two chits and patient will select one treatment chit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sciatic pain resulting from disc herniation.</hc_freetext>
      <i_freetext>Intervention 1: treatment group (A) receive baseline treatment include moist hot packs for 10 minutes at lower back then apply mechanical traction for 10 minutes then do shockwave therapy at paravertebral area  of L4, L5 and S1 with frequency of 5 HZ and 1000 shocks/session then do McKenzie exercise (extension approach). total 3 sessions will be perform once a week for 4 weeks. Intervention 2: Control group (B) receive baseline treatment includes moist hot pack for 10 minutes then apply mechanical traction for 10 minutes then do McKenzie exercises (extension approach) and shockwave therapy will not apply in control group. Total three sessions will perform per week for 4 weeks.</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>Dr Nazia Sarfraz; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 KM Sargodha road Health Sciences Wing The University of Faisalabad</address>
        <city>faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>nazia.sarfraz@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Nazia Sarfraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4Km Sargodha road Faisalabad, Health sciences wing The University of Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>nazia.sarfraz@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both males and females between the age of 30-45 years having low back pain
patient with moderate to severe  low back and buttock pain runs down to the leg and having positive straight leg raising test between the angle of 30 to 70 degree
patients have numbness and weakness and feeling of pins and needles in affected leg and feet
pain that worsen with movement
chronic sciatic pain lasts for 1 to 3 months
psychological stable patients</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>acute pain
bilateral sciatica
spinal fractures
pregnancy
previous history of any inflammatory disease
presence of any implant
epiphyseal plate in the area
any malignant condition
patients with fixed contractures in the lower limb
patients having phobia with shockwaves</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sciatica, unspecified side</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>treatment group (A) receive baseline treatment include moist hot packs for 10 minutes at lower back then apply mechanical traction for 10 minutes then do shockwave therapy at paravertebral area  of L4, L5 and S1 with frequency of 5 HZ and 1000 shocks/session then do McKenzie exercise (extension approach). total 3 sessions will be perform once a week for 4 weeks</i_keyword>
      <i_keyword>Control group (B) receive baseline treatment includes moist hot pack for 10 minutes then apply mechanical traction for 10 minutes then do McKenzie exercises (extension approach) and shockwave therapy will not apply in control group. Total three sessions will perform per week for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain will be measured at the time of initial assessment, then after two weeks and after fourth week. Method of measurement: Visual analogue scale consist of 0 to 10 numbering for measurement of pain intensity ask patients to select any number from 0 to 10.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Questioner will be used at the time of assessment then after two weeks and after fourth week. Method of measurement: The patient is instructed to put a mark next to each appropriate statement, at the beginning of treatment, a patient’s score was 12 and, at the conclusion of treatment, her score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-28</approval_date>
        <contact_name>Ethical committee of The University Of Faisalabad</contact_name>
        <contact_address>Sargodha Road, University Town, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
