<?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>IRCT20230731058990N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-18</date_registration>
      <primary_sponsor>University of Lahore, Lahore</primary_sponsor>
      <public_title>Neurodynamic and active release technique effects in carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Therapeutic effects of neurodynamic and active release technique in carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76022</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Carpal tunnel syndrome, symptom severity index, disabilities of arm, shoulder and hand questionnaire, Phalen's test, Randomization description: Participants were randomized by using concealed envelope method. In this, sealed opaque envelops with treatment regimen written were provided to the participants. Once a patient had consented to enter a trial room, an envelope was opened, and the patient was then offered the allocated treatment, Blinding description: Assessor will only assess the patient at baseline,4th week and at 8th week for treatment outcomes. Assessor safe the data for follow-up and will not share it with any therapist or patient. At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.</study_design>
      <phase>3</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A received routine physical therapy included infrared. Infrared will be used for 10 minutes in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, special techniques used for median nerve mobilization include gliding and tension maneuvers with duration of 5 minutes (8 repetitions in which we apply manual technique for 20s and rest for 10s) in each session. 1.Stand with your elbow resting at your side with the hand and fingers pulled back as far as pain allows. Keeping the hand and fingers pulled back gently straighten your elbow. 2. While standing, move the arm slightly out to the side and bring your wrist and hand backwards so your palm is facing outwards. Intervention 2: Intervention group: Group B received routine physical therapy included infrared. Infrared will be used for 10 minutes in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, active release technique will be used which is a manual soft-tissue mobilization therapy, means that we use our hands to identify muscle adhesions. Patient will be in sitting position and we will approach to patient on his/her affected side and apply gentle pressure on adhesion point and move thumb on patient Flexor retinaculum clockwise and anticlockwise direction for 5 minutes.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic data and data related to final outcome will be shared by maintaining the confidentiality.

When:
Data will be available from August 2024 to November 2024 after the 6 months of publication. The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's International Clinical Trials Registry Platform; this occur before the first participant is enrolled.

To whom:
Deidentified IPD and any additional information will be shared for the people working in academic institution and clinical research writers.

Conditions:
for research purpose

Where to obtain:
To the corresponding author of the study, Dr Sania Naz and can contact on +923044407035 saaniaanaz@gmail.com can visit these search engines, you can find my study easily here https://www.researchgate.net/ https://scholar.google.com/

How to obtain:
Open-access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by Director in Charge and in case of eligibility, it would be shared in two weeks.

Comments:
I want randomized clinical trial registration.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sania Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km defense road Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 304 4407035</telephone>
        <email>sania.naz642@gmail.com</email>
        <affiliation>University of Lahore, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Kashaf Faraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km defense road Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 304 6541357</telephone>
        <email>kashaffraz@gmail.com</email>
        <affiliation>University of Lahore, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age is between 25-50 years
Both gender
Complaints of pain, numbness or tingling in the first three digits
Positive Phalen’s Sign
Unilateral Compression of Nerve</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Carpal Tunnel Release Surgery
Patients with median nerve involvement in proximal areas such as thoracic outlet syndrome, cervical radiculopathy
Steroid injection in the carpal tunnel, thenar muscle atrophy
Metabolic diseases such as diabetes, severe thyroid disorders, anemia and pregnancy</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A received routine physical therapy included infrared. Infrared will be used for 10 minutes in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, special techniques used for median nerve mobilization include gliding and tension maneuvers with duration of 5 minutes (8 repetitions in which we apply manual technique for 20s and rest for 10s) in each session. 1.Stand with your elbow resting at your side with the hand and fingers pulled back as far as pain allows. Keeping the hand and fingers pulled back gently straighten your elbow. 2. While standing, move the arm slightly out to the side and bring your wrist and hand backwards so your palm is facing outwards.</i_keyword>
      <i_keyword>Intervention group: Group B received routine physical therapy included infrared. Infrared will be used for 10 minutes in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, active release technique will be used which is a manual soft-tissue mobilization therapy, means that we use our hands to identify muscle adhesions. Patient will be in sitting position and we will approach to patient on his/her affected side and apply gentle pressure on adhesion point and move thumb on patient Flexor retinaculum clockwise and anticlockwise direction for 5 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper-extremity disability and symptoms. Timepoint: Baseline, 4th week and 8th week of treatment. Method of measurement: Disabilities of the arm, shoulder and hand (DASH) questionnaire.</prim_outcome>
      <prim_outcome>Symptom severity. Timepoint: Baseline, 4th week and 8th week of treatment. Method of measurement: Symptoms Severity Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Baseline, 4th and 8th week of treatment. Method of measurement: Short Form-12.</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>University of Lahore, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-22</approval_date>
        <contact_name>Research Ethics Committee (REC)</contact_name>
        <contact_address>1-Km defense road Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
