<?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>IRCT2016100230083N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-19</date_registration>
      <primary_sponsor>Vice chancellor for research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of cold therapy and electrical stimulation on signs and symptoms of  muscle soreness due to overwork in amateur athletes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing effects of cryotherapy and TENS on signs and symptoms of delayed onset muscle soreness in amateur athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24018</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delayed onset muscle soreness.</hc_freetext>
      <i_freetext>Intervention 1: Inducing delayed-onset muscle soreness (DOMS) [Independent variable] [for all groups]:&#13;
For inducing delayed onset muscle soreness in the hamstrings, the participant is in the kneeling position on a bed and the hands are by the sides. Distal of the legs is secured using a strap. The participant is asked to bend forward from the knees as further as possible. He is instructed not to bend the hip joints or the spine. In this way, the hamstrings have to control, eccentrically, the lowering of the thigh, pelvic and trunk segments as a rigid lever. The procedure consists of 12 sets including, six repetitions. Ten seconds and 2 min rest are allowed between each repetition and set, respectively. Intervention 2: Trans cutaneous Electrical Nerve Stimulation( TENS group):&#13;
Transcutaneous electrical nerve stimulation is applied by an ITO stimulator (Model 1207, ITO, Co., Ltd, Japan). The participant is in the prone position. One pair of rubber electrodes is placed longitudinally on the most painful site of the musculotendinous junction of the hamstrings in the lower one-third of the muscle. TENS is applied once in a day for three consecutive days. Frequency, pulse width and duration are set at 110 Hz, 200 µs, and 20 min, respectively. Intensity is increased up to a sensory level, that is, the participant should feel a paresthesia with no muscle contraction. Intervention 3: Cryotherapy( cryotherapy group):&#13;
The participant is in the prone position. A wet towel is put on the hamstrings muscle. Ice bag containing mixed pieces of ice and water is put on the towel and covered by another towel. The intervention lasts for 20 min. The cryotherapy protocol consists of three repetitions daily (8-hour intervals) for three consecutive days. The size of the ice bag is chosen according to the contour of the hamstrings. Any adverse effect of icing is monitored by the researchers in the first session. Intervention 4: No intervention after inducing DOMS (control group):&#13;
No intervention was prescribed for the control group after inducing DOMS.</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. Kazem Malmir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, School of Rehabilitation, Enghelab Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>kmalmir@tums.ac.ir</email>
        <affiliation>School of Rehabilitation, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Malmir Kazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, School of Rehabilitation, Enghelab Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>kmalmir@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
No lower extremity injury during previous year; No contraindication for using electrical stimulation or icing;  No sensitivity to ice or electrical stimulation during the tests; Not any heavy training two weeks before performing the tests. &#13;
Exclusion criteria:&#13;
Any burning in the skin due to TENS or any frostbite due to cryotherapy; Any unsatisfactory feeling in participants to continue testing process</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of muscle, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Inducing delayed-onset muscle soreness (DOMS) [Independent variable] [for all groups]:&#13;
For inducing delayed onset muscle soreness in the hamstrings, the participant is in the kneeling position on a bed and the hands are by the sides. Distal of the legs is secured using a strap. The participant is asked to bend forward from the knees as further as possible. He is instructed not to bend the hip joints or the spine. In this way, the hamstrings have to control, eccentrically, the lowering of the thigh, pelvic and trunk segments as a rigid lever. The procedure consists of 12 sets including, six repetitions. Ten seconds and 2 min rest are allowed between each repetition and set, respectively.</i_keyword>
      <i_keyword>Trans cutaneous Electrical Nerve Stimulation( TENS group):&#13;
Transcutaneous electrical nerve stimulation is applied by an ITO stimulator (Model 1207, ITO, Co., Ltd, Japan). The participant is in the prone position. One pair of rubber electrodes is placed longitudinally on the most painful site of the musculotendinous junction of the hamstrings in the lower one-third of the muscle. TENS is applied once in a day for three consecutive days. Frequency, pulse width and duration are set at 110 Hz, 200 µs, and 20 min, respectively. Intensity is increased up to a sensory level, that is, the participant should feel a paresthesia with no muscle contraction</i_keyword>
      <i_keyword>Cryotherapy( cryotherapy group):&#13;
The participant is in the prone position. A wet towel is put on the hamstrings muscle. Ice bag containing mixed pieces of ice and water is put on the towel and covered by another towel. The intervention lasts for 20 min. The cryotherapy protocol consists of three repetitions daily (8-hour intervals) for three consecutive days. The size of the ice bag is chosen according to the contour of the hamstrings. Any adverse effect of icing is monitored by the researchers in the first session.</i_keyword>
      <i_keyword>No intervention after inducing DOMS (control group):&#13;
No intervention was prescribed for the control group after inducing DOMS.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Active knee extension range of motion. Timepoint: Before, 24, 48 and 72 hours after inducing delayed-onset muscle soreness. Method of measurement: Digital goniometer.</prim_outcome>
      <prim_outcome>Triple hop distance. Timepoint: before, 24, 48 and 72 hours after inducing delayed-onset muscle soreness. Method of measurement: Triple hop distance test.</prim_outcome>
      <prim_outcome>Thigh girth. Timepoint: before, 24, 48 and 72 hours after inducing delayed-onset muscle soreness. Method of measurement: Flexible meter(upper-middle-lower regions of the thigh).</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: before, 24, 48 and 72 hours after inducing delayed-onset muscle soreness. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>N/A. Timepoint: N/A. Method of measurement: N/A.</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>Vice chancellor for research of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-03</approval_date>
        <contact_name>Ethics commette of Rehabilitation and Nursing And Midwify School of Tehran University of Medical Sci</contact_name>
        <contact_address>Tehran Province, Tehran, District 6, Nosrat St Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
