<?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>IRCT201109231675N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-31</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Action Potential Simulation and Low Level LASER in Reducing Pain and Improving Function of the Knee: A Randomized Controlled Trial of Women with Knee Osteoarthrosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Action Potential Simulation and Low Level LASER in Reducing Pain and Improving Function of the Knee: A Randomized Controlled Trial of Women with Knee Osteoarthrosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1163</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Knee Osteoarthrosis.</hc_freetext>
      <i_freetext>Intervention 1: LASER Group: A low-level Ga-As LASER was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 9 J/cm2 dosages per minute, for 6 minutes per session. In addition, this group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed. Intervention 2: Action Potential Simulation Group: We applied Action Potential Simulation with intensity of 1mA, 150 Hz frequency, for 16 minutes per session. This group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Asghar Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64855-98136</zip>
        <telephone>+98 54 1325 8445</telephone>
        <email>akbari_as@yahoo.com; akbaria@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Asghar Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64855-98136</zip>
        <telephone>+98 54 1322 8445</telephone>
        <email>akbari_as@yahoo.com; akbaria@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age between 14 and 40; Having knee pain according to Altman’s classification; Lack of regular exercise (non-professional or professional) over the past 10 years; Not regular or irregular (5 times per week) of analgesics and steroidal and nonsteroidal anti-inflammatory drugs within 2 months prior to study entry.     &#13;
Exclusion criteria: Insufficient treatment; Using other therapeutic modalities during the study; Trauma; Doing surgery during the study; Exacerbation of symptoms following the intervention; Patients who have had a history of knee surgery; Intra-articular injections in the past 6 months; and Lower extremity fracture in last 3 months.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.0, M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary gonarthrosis, bilateral and Other primary gonarthrosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>LASER Group: A low-level Ga-As LASER was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 9 J/cm2 dosages per minute, for 6 minutes per session. In addition, this group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed.</i_keyword>
      <i_keyword>Action Potential Simulation Group: We applied Action Potential Simulation with intensity of 1mA, 150 Hz frequency, for 16 minutes per session. This group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee pain. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Knee function. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Knee and Osteoarthritis Outcome Score (KOOS).</prim_outcome>
      <prim_outcome>Range of knee flexion. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Stiffness, pain and physical function. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Index (WOMAC).</prim_outcome>
      <prim_outcome>Atrophy. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Tape measure.</prim_outcome>
      <prim_outcome>Swelling. Timepoint: Before intervention, 4 weeks after intervention. Method of measurement: Tape measure.</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>No trial id </sec_id>
        <issuing_authority>No registration</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for Research of Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-10-22</approval_date>
        <contact_name>Ethics Commitee of University of Sistan and Baluchestan</contact_name>
        <contact_address>Daneshgah Blvd., University of Sistan and Baluchestan Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
