<?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>IRCT20220227054142N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of TECAR and exercise therapy in patients with chronic nonspecific back pain</public_title>
      <acronym>TECAR(of resistive capacitive electric transfer method)</acronym>
      <scientific_title>The effect of resistive capacitive electric transfer method and  flexibility exercises on pain, range of motin, disability and quality of life in patients with chronic nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62268</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: Participants are initially divided into two groups 1 and 2 with the help of Random Number program
The number one in the application indicates the addiction therapy group and the exercise therapy placebo, and the number 2 in the software indicates the addiction therapy and exercise therapy group, Blinding description: The patient does not know how to group and study
The data analyzer does not know how to group and study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: chronic nonspecific low back pain. Condition 2: Chronic nonspecific back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All primary and secondary variable data will be published

When:
About 6 months after printing the results.

To whom:
This information will be available to people working in academic institutions as well as graduate physiotherapists.

Conditions:
The use of results and data for academic institutions and for the purpose of conducting research is available only by mentioning the source.

Where to obtain:
Via email and contact Mehdi Jarghouei at ptmehdi.j1995@gmail.com

How to obtain:
After submitting the response request, finally up to 2 weeks later

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Jarghouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Shahed Alley 3</address>
        <city>khansar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8791816764</zip>
        <telephone>+98 31 5777 0545</telephone>
        <email>ptmehdi.j1995@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Jarghouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Shahed Alley 3</address>
        <city>khansar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8791816764</zip>
        <telephone>+98 31 5777 0545</telephone>
        <email>ptmehdi.j1995@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain in the lower back for at least 3 months if the exact cause is not known
• The person has the ability to do exercises
• The person is willing to do exercises and therapy sessions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No acute back pain (at least 3 months after pain)
Infection in the lumbar region
Fracture or tumor
History of lumbar surgery
Pace Maker or any electrical device in the body
Severe deformity in the lower limbs or spine such as scoliosis
Specific diseases of the spine such as severe osteoporosis or ankylosing spondylitis
Neurological problems such as stroke or other problems that deprive a person of the ability to perform exercises and tests
Lack of understanding and inability of the questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>M54.5</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:</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain:  The effect of  resistive capacitive electric transfer method and flexibility exercises in patients with chronic nonspecific low back pain. Timepoint: Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days). Method of measurement: Visual-analog scale.</prim_outcome>
      <prim_outcome>Disability: Any limitation or inability to perform an activity in the normal range that is possible for a normal and healthy person to perform. Timepoint: Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days). Method of measurement: Oswestry Disability Index (ODI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life :: Quality of life is the perception of each person of their health status and the degree of satisfaction with this situation. Timepoint: Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days). Method of measurement: Persian version of the 12-item SF-12 questionnaire.</sec_outcome>
      <sec_outcome>Range of motion: The amount of movement in a joint that depends on the bone structure and physiological characteristics of the connective tissue around the joint. Timepoint: Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days). Method of measurement: در بررسی خم شدن طرفی فرد به دیوار تکیه داده و بدون این که شانه هایش از دیوار فاصله بگیرد به طرف خم می شود و فصله ی نوک انگشتان تا زمین اندازه گرفته می شود.</sec_outcome>
      <sec_outcome>Range of motion Bending forward: The amount of movement in a joint that depends on the bone structure and physiological characteristics of the connective tissue around the joint. Timepoint: Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days). Method of measurement: Modified Schober Index.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-24</approval_date>
        <contact_name>Ethics committee of iran University of Medical Sciences</contact_name>
        <contact_address>No. 1, daneshgah Ave., shahed3 alley., khansarTown khansar Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
