<?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>IRCT20230731058981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-05</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effect of Pain Neuroscience Education on Chronic Pain in Diabetic Neuropathy and its Impact on Quality of Life</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Pain Neuroscience Education on Chronic Pain in Diabetic Neuropathy and its Impact on Quality of Life</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71868</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients will be allocated in two groups (group A will be treatment group and group be will control group).Computer based random number generator will be used to assign each patient a number from 1 to 30, and then will assign those with odd numbers to group A and those with even numbers to group B, Blinding description: only participants will be blind.</study_design>
      <phase>1</phase>
      <hc_freetext>Diabetic neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pain Neuroscience educational sessions will be given by help of Hand drawings and by leaflets, in Individual session. PNE session  will be administered 2 times per week for 6 weeks by a single physiotherapist for 1 hour. Conventional Therapy (TENS, Stretching and strengthening exercises), High-Frequency TENS with 100Hz frequency, adjustable 200-400 micro seconds pulse width and 20 minutes duration. The intensity of stimulus will gradually increase until the patient can recognize the stimulation but was not make uncomfortable. Strengthening(stair climbing) and 2-4 repetition of stretching exercises (static stretch with 30 second hold), 1-3 sets on 2-3 alternative days of week for 6 week. Intervention 2: Control group: Group B will receive Conventional Therapy (TENS, stretching and strengthening exercises) which is Control Group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is In order to maintain the confidentiality of study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sidra Majeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Faisalabad, Health Sciences Wing · University Town, Sargodha Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>sidra.majeed@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Anbreena Rasool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The university of Faisalabad, Health Sciences Wing · University Town, Sargodha Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>anbreena.rasool@tuf.edu.pk</email>
        <affiliation>The university of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Between age of 50 -70years
Diabetic Neuropathy on basis of Monofilament testing
History of pain more than 6 months
HBA1C (Hemoglobin A1c) ≥ 6.5%
History of Diabetes more than 5 years
Both Male and Female Genders</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals with diagnosed Neurological Disease/ All other neuropathies
Wounds and Amputation in lower Extremity
With Auditory disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E13.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified diabetes mellitus with diabetic neuropathy, unspecified</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: Pain Neuroscience educational sessions will be given by help of Hand drawings and by leaflets, in Individual session. PNE session  will be administered 2 times per week for 6 weeks by a single physiotherapist for 1 hour. Conventional Therapy (TENS, Stretching and strengthening exercises), High-Frequency TENS with 100Hz frequency, adjustable 200-400 micro seconds pulse width and 20 minutes duration. The intensity of stimulus will gradually increase until the patient can recognize the stimulation but was not make uncomfortable. Strengthening(stair climbing) and 2-4 repetition of stretching exercises (static stretch with 30 second hold), 1-3 sets on 2-3 alternative days of week for 6 week.</i_keyword>
      <i_keyword>Control group: Group B will receive Conventional Therapy (TENS, stretching and strengthening exercises) which is Control Group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: Visual Analog scale (VAS) for pain intensity and Norfolk QOL-DN for quality of life will be measured as Baseline before start of Intervention and after 6 weeks at end of Intervention.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethics committee of The University of Faisalabad</contact_name>
        <contact_address>The university of Faisalabad, main Sargodha road, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
