<?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>IRCT201111014203N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-11-22</date_registration>
      <primary_sponsor>Deputy of Research, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Glucosamine in knee osteoarthrosis</public_title>
      <acronym></acronym>
      <scientific_title>Study the efficacy of Glucosamine phonophoresis in knee osteoarthrosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthrosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention (3, Phonophoresis of glucosamine): Standard treatment (includes: IR, TENS and Exercise) with phonophoresis of glucosamine.  Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, in combination of 50% gel and 50% glucosamine ointment, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions. Intervention 2: Intervention (2, Ultrasound): Standard treatment (includes: IR, TENS and Exercise) with US. Standard treatment includes : IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions. Intervention 3: Intervention (1, Placebo US): Standard treatment (includes: IR, TENS and Exercise) with placebo US. Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Placebo ultrasound for 5 minutes, around the knee joint. For 10 sessions.</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. Atefeh Aminian Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 5 Damghan road, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439957181</zip>
        <telephone>+98 23 1335 4182</telephone>
        <email>aminfar83@yahoo.com aminianfar@razi.tums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Atefeh Aminian Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 5 Damghan road, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439957181</zip>
        <telephone>+98 23 1335 4182</telephone>
        <email>aminfar83@yahoo.com aminianfar@razi.tums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: presence of mechanical knee pain, osteophytes in knee X-ray, age above 50 years, morning stiffness lasting less than 30 minutes, crepitus in palpation of knee joint.&#13;
Exclusion criteria: presence of other knee joint diseases, osteoarthrosis of hip and/or ankle joints, radicular pain originating from lumbar spine, physiotherapy history with intra/peri articular injection (corticosteroids or hyaluronic acid) during past six months,  physiotherapy history during past six months, surgery history of knee joints, psychotic or mental disorders, neoplasm, infections, bleeding, neurologic disorders (sensory or motor)</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M15.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Erosive (osteo)arthrosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention (3, Phonophoresis of glucosamine): Standard treatment (includes: IR, TENS and Exercise) with phonophoresis of glucosamine.  Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, in combination of 50% gel and 50% glucosamine ointment, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions.</i_keyword>
      <i_keyword>Intervention (2, Ultrasound): Standard treatment (includes: IR, TENS and Exercise) with US. Standard treatment includes : IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions.</i_keyword>
      <i_keyword>Intervention (1, Placebo US): Standard treatment (includes: IR, TENS and Exercise) with placebo US. Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Placebo ultrasound for 5 minutes, around the knee joint. For 10 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: WOMAC INDEX Questionaire.</prim_outcome>
      <prim_outcome>Duration of Morning stifness. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on scale of 0-4.</prim_outcome>
      <prim_outcome>Measurement of resting and activity pain. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on Visual Analogue Scale (0-10).</prim_outcome>
      <prim_outcome>Active range of motion of knee flexion. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on Goniometery.</prim_outcome>
      <prim_outcome>Swelling of knee joint. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on tape measurement.</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>Deputy of Research, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-09-26</approval_date>
        <contact_name>Deputy of Research, Semnan University of Medical Sciences</contact_name>
        <contact_address>Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran. Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
