<?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>IRCT20230405057829N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Radial shockwave therapy in trigger finger treatment</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Radial shockwave therapy in trigger finger treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is performed as restricted randomization and random allocation rule. In this method, equal number of each group (according to the amount of sample size) are written on papers of the same size and design, numbers 1 and 2 (representing the first and second group) and inside non-transparent envelopes. that it is not possible to see inside the envelope) is placed and the sufferers are asked to choose one of them randomly after moving the envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Trigger Finger.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients are treated with radial shockwave in 6 sessions with one-week intervals, and the shockwave treatment protocol includes 1500 shocks, 2.5 bar energy and 15 Hz frequency. In this group, in addition to shockwave treatment for trigger finger patients A splint is also prescribed. Intervention 2: Control group: In this group of patients, trigger finger splint is prescribed for treatment. The prescribed splint in these patients places the MCP joint in 15 degrees of flexion and the patient is taught to use it day and night (24 hours) for 6 weeks. During the treatment, in order to follow up the patients' use of the splint, the researcher calls them by phone.</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 "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maede.Molaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firuzgar hospital,Behafarin street,Valiasr square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۵۹۳۷۴۸۷۱۱</zip>
        <telephone>+98 21 8214 1000</telephone>
        <email>maedemolaei415@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maede Molaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Square, Behafarin Street, Firouzgar Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۵۹۳۷۴۸۷۱۱</zip>
        <telephone>+98 21 8214 1000</telephone>
        <email>maedemolaei415@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients older than 18 years
Patients with trigger finger grade two or three</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have been previously treated with PT, corticosteroids and surgery
Patients with local infection, malignancy, rheumatoid arthritis, pregnancy and arrhythmia
Patients with musculoskeletal problems or nerve injury in the upper limb
Not using a splint during 6 weeks of treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M65.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nodular tendinous disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients are treated with radial shockwave in 6 sessions with one-week intervals, and the shockwave treatment protocol includes 1500 shocks, 2.5 bar energy and 15 Hz frequency. In this group, in addition to shockwave treatment for trigger finger patients A splint is also prescribed.</i_keyword>
      <i_keyword>Control group: In this group of patients, trigger finger splint is prescribed for treatment. The prescribed splint in these patients places the MCP joint in 15 degrees of flexion and the patient is taught to use it day and night (24 hours) for 6 weeks. During the treatment, in order to follow up the patients' use of the splint, the researcher calls them by phone</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The intensity of the patient's pain is based on scoring from one to ten. Timepoint: Before the treatment and after completing the 6-week treatment period and 3 months after the treatment. Method of measurement: How much the patient knows the intensity of his pain and gives a score to his current pain from 0 (no pain) to 10 (the most severe pain that a person can experience in his lifetime). We ask the patient to indicate his pain level on a special 10 cm ruler.</prim_outcome>
      <prim_outcome>Frequency of triggering. Timepoint: Before the treatment and after completing the 6-week treatment period and 3 months after the treatment. Method of measurement: The patient gives a score from zero to ten on the number of times the trigger finger gets stuck. Zero is the least disorder and ten is the most severe condition.</prim_outcome>
      <prim_outcome>Functional impact of triggering. Timepoint: Before the treatment and after completing the 6-week treatment period and 3 months after the treatment. Method of measurement: The patient scores the dysfunction caused by trigger finger from 0 to 10. 0 is the least disorder and 10 is the most severe.</prim_outcome>
      <prim_outcome>Severity of triggering. Timepoint: Before the treatment and after completing the 6-week treatment period and 3 months after the treatment. Method of measurement: The patient scores the severity of the locking of the trigger finger from zero to ten. Zero is the least disorder and ten is the most severe condition.</prim_outcome>
      <prim_outcome>Disability of upper limb. Timepoint: Before the treatment and after completing the 6-week treatment period and 3 months after the treatment. Method of measurement: Quick dash questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-17</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Baharestan Square,Shafa hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
