<?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>IRCT20241228064194N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>High power Laser in carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Evaluation of High-power Laser versus Anti-Inflammatory Effects of Corticosteroid Injection on Symptoms and Function in Patients with Mild to Moderate Carpal Tunnel Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81027</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomized (block randomization method with the block size 4 using Excel software), phase 4 on 40 patients, Blinding description: This was a single-blind study. A physician (specialist in physical medicine and rehabilitation), who was unaware of the treatment group of each patient, was responsible for the initial electrodiagnostic assessment and for collecting data from all patients (including demographic data, pain intensity [VAS], Boston questionnaire, grip strength, and electrodiagnostic findings). Another physician performed high-power laser therapy, and a therapist administered the cortisone injections, both of whom were blinded to the patients’ group assignments. The patients themselves were not blinded to the treatment they received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will receive six sessions of high-power laser therapy over three weeks, with a two-day interval between each session, each lasting five minutes, according to the predefined protocol on the Novin high-power laser device (30 Hz frequency, 1.5 W power, and 30 J/cm² dose). The device is calibrated before use and is the same for all patients. Due to the lack of consistency in laser parameters across studies using high-power lasers, we used the preset program for carpal tunnel syndrome (CTS) provided by the device. The session begins with the patient seated in a relaxed position, with the forearm resting on the treatment table. In the main unit of the device, the therapist selects the CTS treatment program. Then, after providing protective glasses for both the patient and therapist, the treatment begins, and the scanner probe is moved back and forth over the flexor retinaculum of the wrist (3 cm proximal and distal to the wrist crease) for five minutes, simultaneously with pedal pressure, which activates the laser. The pedal pressure corresponds to the laser exposure. All these steps are performed by one physician for all patients. Intervention 2: Control group: For this group of patients, routine and standard treatment for carpal tunnel syndrome is performed. This treatment includes an injection of 1 mL of triamcinolone (40 mg) in the distal wrist crease.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is “There is no more information available.”</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Khosravipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.5.Gharib St,Keshavarz Blvd., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2291</telephone>
        <email>khosravifahime35@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohadese Azadvari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.5.Gharib St,Keshavarz Blvd., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643491</zip>
        <telephone>+98 912 634 2982</telephone>
        <email>drazadvari@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
mild to moderate carpal tunnel syndrome (CTS) based on nerve conduction study (NCS) findings</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have surgical indications, such as severe weakness, thenar muscle atrophy, or lack of response to treatment.
Concurrent neurological disorders based on electromyography observations, such as polyneuropathy, ulnar neuropathy, proximal median neuropathy, plexopathy, mononeuritis multiplex, cervical radiculopathy.
pregnancy
infection
malignancy
patients who have received corticosteroid injections in the past six months.
patients with a history of wrist surgery for CTS treatment,
allergy to corticosteroids
contraindications for corticosteroids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients will receive six sessions of high-power laser therapy over three weeks, with a two-day interval between each session, each lasting five minutes, according to the predefined protocol on the Novin high-power laser device (30 Hz frequency, 1.5 W power, and 30 J/cm² dose). The device is calibrated before use and is the same for all patients. Due to the lack of consistency in laser parameters across studies using high-power lasers, we used the preset program for carpal tunnel syndrome (CTS) provided by the device. The session begins with the patient seated in a relaxed position, with the forearm resting on the treatment table. In the main unit of the device, the therapist selects the CTS treatment program. Then, after providing protective glasses for both the patient and therapist, the treatment begins, and the scanner probe is moved back and forth over the flexor retinaculum of the wrist (3 cm proximal and distal to the wrist crease) for five minutes, simultaneously with pedal pressure, which activates the laser. The pedal pressure corresponds to the laser exposure. All these steps are performed by one physician for all patients.</i_keyword>
      <i_keyword>Control group: For this group of patients, routine and standard treatment for carpal tunnel syndrome is performed. This treatment includes an injection of 1 mL of triamcinolone (40 mg) in the distal wrist crease.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Boston Questionnaire Score. Timepoint: Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention. Method of measurement: Boston Questionnaire.</prim_outcome>
      <prim_outcome>Patient Satisfaction level. Timepoint: Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention. Method of measurement: Patient Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Visual Analog Scale for pain and numbness score. Timepoint: Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention. Method of measurement: Visual Analog Scale for pain and numbness.</prim_outcome>
      <prim_outcome>Median Nerve Conduction Study (NCS) Findings. Timepoint: Before the intervention and 3 months after the completion of the intervention. Method of measurement: Nerve Conduction Study (NCS) 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-29</approval_date>
        <contact_name>Ethics committee of Emam Khomeini complex Hospital</contact_name>
        <contact_address>No.5.Gharib St,Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
