<?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>IRCT20221105056408N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-22</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effect of Tecar with Low power laser on peripheral neuropathy and quality of life in typ2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Tecar with Low Level Laser in improving neurological symptoms and Quality of life in lower extremity Peripheral Neuropathy in type2 diabetes patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66973</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The clinical trial has3 intervention groups with parallel groups and simple block randomization on 15 people in each group, Randomization description: The randomization is a simple blocked  method, we will have three groups of 15 people, each group will be assigned a code, and for each group, the code of the same group will be placed inside the closed envelope, and the patient will randoly choose an envelope, Blinding description: The main researcher will not divide the samples into two groups and this work will be done by the research assistant who is a physiotherapy expert. Also, the evaluator will not know about the grouping of people. Also, the intervention is done by another person and the evaluation before and after the treatment is done by the main researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peripheral neuropathy of the lower limb of type2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tecar on + Laser off. Intervention 2: Intervention group: Tecar on + Laser on. Intervention 3: Intervention group: Laser on + Tecar off.</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:
All above will be published in article

When:
After the article publication

To whom:
Researchers and students in academic centers

Conditions:
Other researchers and therapists in the reahabilitation and medical fild can use this study

Where to obtain:
After the article publication, people can find the article by searching in internet and access the data

How to obtain:
After requesting the documents, the person in charge of the research project must receive a written permission from the university and after obtaining the permission, send the documents,so summary will be sent about 6 months after the request for this data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Javan Amoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N. 10, Abazar alley 4, Moallem street, Amol Town</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4615798356</zip>
        <telephone>+98 11 4422 4357</telephone>
        <email>javanamoli@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Javan Amoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N. 10, Abazar Alley 4, Moallem Street, Amol Town</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4615798356</zip>
        <telephone>+98 11 4422 4357</telephone>
        <email>javanamoli@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 50 years
Diagnosis of type2 diabetes by endocrinologist and neurologist
Minimum pain score of 4 based on visual analog scale(VAS)
Body mass index &lt; 30
Nerve conduction velocity(Ncv) &lt; 40 tibial motor nerve
Controlled blood sugar for last three months(Glycosylated hemoglobin Hba1c &lt; 8.5)</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of symptoms of non diabetic neuropathy
Systemic peripheral vascular involvement
Pregnancy
Patients with malignant tumors
Chronic coronary artery,lung and kidney diseases
Patients with pacemakers or mechanical insulin pumps
Patient with knee joint teplacement and the presence of metal plaque in the lower limb
Patients addicted to drugs, cigarettes and alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Tecar on + Laser off</i_keyword>
      <i_keyword>Intervention group: Tecar on + Laser on</i_keyword>
      <i_keyword>Intervention group: Laser on + Tecar off</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before, after10 session and 3month after intervention. Method of measurement: Visual analogue scale (numerical)(VAS).</prim_outcome>
      <prim_outcome>Nerve conduction velocity, tibial motor nerve. Timepoint: Before, after10 session and 3month after intervention. Method of measurement: Electromyography device.</prim_outcome>
      <prim_outcome>The feeling of tactile soles of the foot. Timepoint: Before, after10 sessions and 3month after intervention. Method of measurement: By Sims Weinstein 10g monofilament ten points on the soles of the feet will be evaluated.</prim_outcome>
      <prim_outcome>Mishigan questionnaire. Timepoint: Before, after10 sessions and 3month after intervention. Method of measurement: The questionnaire has two parts, one part evaluates and records  by evaluator and the other part fills by patient.</prim_outcome>
      <prim_outcome>Ankle brachial index, it is the ratio of ankle systolic blood pressure to arm systolic blood pressure. Timepoint: Before, after10 sessions and 3month after intervention. Method of measurement: By digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Sensory Sural nerve amplitude. Timepoint: Before, after10 sessions and 3month after intervention. Method of measurement: Electromyography device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Befor intervention and after three months10 session intervention. Method of measurement: Summary questionnaire of 26 questions of the World Health Organization.</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>Deputy of researches and technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-11</approval_date>
        <contact_name>Ethics committee of shahid beheshti university of Medical Sciencesof medical sciences</contact_name>
        <contact_address>No.10, Abazar4 alley, Moallem Street, Amol Town Amol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
