<?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>IRCT20210820052237N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-31</date_registration>
      <primary_sponsor>Yasmin physiotherapy center</primary_sponsor>
      <public_title>Effect of nerve mobilization in carpal tunnel syndrome patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of median and ulnar nerve neurodynamics to improve motor hand function in carpal tunnel syndrome patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Non probability purposive sampling technique will be used for randomization of 30 patients of carpal tunnel syndrome and participants will be allocated into two groups: Active control group A and intervention group B. Participants will be randomized by choosing sealed and identical slips of paper which will contain their group numbers, Blinding description: The participants will not be aware of the study groups and this will be accomplished by keeping them anonymous for the study period.</study_design>
      <phase>3</phase>
      <hc_freetext>Decreased motor hand function with sensory, motor hand symptoms and weakness due to median nerve entrapment at wrist joint.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Active control Group A will receive common treatment (ultrasound therapy and tendon gliding exercises) for 10 minutes and median nerve neurodynamics (10 reps , 3 sets/ session with 1 minute rest interval for 15 minutes duration) 3 days per week for 4 weeks duration. Intervention 2: Intervention group: Intervention group B will receive common treatment (ultrasound therapy and tendon gliding exercises) for 10 minutes with median and ulnar nerve neurodynamics (10 reps of each technique , 3 sets/session, with 1 minute rest interval between sets for 30 minutes duration) 3 days per week for 4 weeks duration.</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 Consent form would be signed by the participants and they would make sure that their data will not be shared anywhere else other than in current study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azka Mustafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Government hospital, Dr. Tusi Rd, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 5389581</telephone>
        <email>info@pmc.edu.pk</email>
        <affiliation>Allied hospital faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azka Mustafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Government hospital, Dr. Tusi Rd, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 5389581</telephone>
        <email>dr.azkamustafa@gmail.com</email>
        <affiliation>Allied hospital faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Carpal tunnel syndrome patients range from 30 to 50 years age including both male and females
Unilateral carpal tunnel syndrome
Diagnosed with mild carpal tunnel syndrome (only sensory symptoms pain, paresthesia and numbness) and moderate carpal tunnel syndrome (motor weakness and symptoms)
Work related carpal tunnel syndrome
Symptoms shorter than one year duration
Willing to participate in the study
Had not undergone any conservative treatment before</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous carpal tunnel syndrome surgery in the study hand
Pain and trauma to the study hand past 12 months
Severe CTS (thenar muscles atrophy)
Previous pharmacotherapy e.g steroid injection in carpal tunnel of study hand in 2 weeks before the study
Polyneuropathy e.g diabetes
Cervical radiculopathy
Current pregnancy
Inflammatory joint diseases e.g rheumatoid arthritis and osteoarthritis
Brachial plexopathy
Thorasic outlet syndrome
Central nervous system disorders (multiple sclerosis and small cerebral infarct)
Thyroid disease
Severe medical illness
Any skin disease and wound condition
History of neoplasm
Previous fracture to the study hand
Language difficulties and cognitive disorders
Known abuse of drugs and alcohol abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Control group: Active control Group A will receive common treatment (ultrasound therapy and tendon gliding exercises) for 10 minutes and median nerve neurodynamics (10 reps , 3 sets/ session with 1 minute rest interval for 15 minutes duration) 3 days per week for 4 weeks duration.</i_keyword>
      <i_keyword>Intervention group: Intervention group B will receive common treatment (ultrasound therapy and tendon gliding exercises) for 10 minutes with median and ulnar nerve neurodynamics (10 reps of each technique , 3 sets/session, with 1 minute rest interval between sets for 30 minutes duration) 3 days per week for 4 weeks duration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Function and symptoms of hand. Timepoint: Before intervention, and after 4th week of intervention. Method of measurement: Boston carpal tunnel questionnaire subscale functional status scale and symptoms severity scale will be used to measure function of affected hand.</prim_outcome>
      <prim_outcome>Disabilities and functional abilities  of upper limb. Timepoint: Before intervention, and after 4th week of intervention. Method of measurement: Quick disabilities of arm, shoulder and hand scale will be used to assess disabilities and functional capacity of upper limb.</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>Yasmin physiotherapy center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-25</approval_date>
        <contact_name>Ethics and technical committee of the University of Faisalabad</contact_name>
        <contact_address>University Town, Sargodha Road Faisalabad. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
