<?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>IRCT20210724051966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-07</date_registration>
      <primary_sponsor>The University of Tarbiat modares</primary_sponsor>
      <public_title>Evaluation of the effects of high power laser and mirror therapy on type I complex regional pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effects of high power laser and mirror therapy on type I complex regional pain syndrome in the hand area</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants are randomly assigned to the study or control group by selecting one of the envelopes in the package, Blinding description: In this study, only participants in the study are blinded. In both groups, mirror therapy and laser therapy are performed, but in the control group, instead of laser, there is only red light.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Complex regional pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: High-power laser with K-laser brand with a power of 5 watts with a dose of 20 joules per square centimeter and a cross-sectional area of 1 cm in 3 phases in the entire hand area. Seven sessions and 3 sessions per week of this intervention is performed. Then, mirror therapy is performed with Range of motion exercise of the hand joints. Intervention 2: Control group: Red light radiation is done in 3 phases and in the whole hand area. Seven sessions and 3 sessions per week of this intervention. Mirror therapy is then performed with Range of motion exercise of the hand joints.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farhan Khorramdel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3115</telephone>
        <email>farhan.khoramdel@yahoo.com</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhan Khorramdel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3115</telephone>
        <email>farhan.khoramdel@yahoo.com</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis by a neurologist or orthopedist of a complex regional pain syndrome in the participant's hand
Men and women with type 1 complex regional pain syndrome based on the Budapest standard
The patient's hand is involved
Having constant pain that is not commensurate with the accident that caused it
There is edema or swelling in the hand relative to the healthy side</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Infection
Radiotherapy in the last 6 months
cancer
Patients with stroke
People's unwillingness to continue treatment for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G90.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complex regional pain syndrome I (CRPS I)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: High-power laser with K-laser brand with a power of 5 watts with a dose of 20 joules per square centimeter and a cross-sectional area of 1 cm in 3 phases in the entire hand area. Seven sessions and 3 sessions per week of this intervention is performed. Then, mirror therapy is performed with Range of motion exercise of the hand joints.</i_keyword>
      <i_keyword>Control group: Red light radiation is done in 3 phases and in the whole hand area. Seven sessions and 3 sessions per week of this intervention. Mirror therapy is then performed with Range of motion exercise of the hand joints.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level changes. Timepoint: Measurement of pain at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention). Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Hand function changes. Timepoint: Measurement of changes in hand function at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention). Method of measurement: Fugl-Meyer Evaluation Scale.</prim_outcome>
      <prim_outcome>Hand swelling changes. Timepoint: Measurement of changes in hand swelling at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention). Method of measurement: Measurement by Figure of eight method.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Measurement of range of motion at the beginning of the study (before the intervention) and at the end of the treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention). Method of measurement: Goniameter.</prim_outcome>
      <prim_outcome>The amount of muscle activity. Timepoint: Measurement of muscle activity at the beginning of the study (before the intervention) and at the end of the treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention). Method of measurement: Electromyography device.</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>The University of Tarbiat modares</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-26</approval_date>
        <contact_name>Ethics committee of Tarbiat modares University</contact_name>
        <contact_address>Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
