<?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>IRCT20150210021034N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The immediate effects of two hand splints in people with triangular fibrocartilage complex injury</public_title>
      <acronym></acronym>
      <scientific_title>The immediate effects of two splinting methods on pain and hand function in people with triangular fibrocartilage complex injury: a randomized crossover study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>degenerative injury of triangular fibrocartilage complex.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The short cockup splint made from thermoplastic sheet. This rigid splint covers the volar surface of the hand from the proximal palmar crease to two-third of forearm area. Thumb freely moves in this splint. This splint is custom made for each participant. Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn. Intervention 2: Intervention group: The hinged ulnar gutter splint consists of two thermoplastic bars placed on the hand and forearm area. This splint fits over ulnar side of the hand and prevents the ulnar deviation of the wrist. The sagital motions of the wrist and thumb movements are not restricted. This splint is custom made for each participant.  Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn. Intervention 3: Control group: The elastic wrist support which covers the middle area of the forearm to palmar surface of the hand and does not apply any mechanical restriction for motions in the hand and forearm.This splint is custom fitted for each participant.  Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.</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:
The study data (excluding the personal details) can be shared with other researchers or systematic reviewers.

When:
No specific limitation is considered.

To whom:
No specific limitation is considered.

Conditions:
No terms and conditions is considered for sharing the data.

Where to obtain:
People can sent their request to the correspondence and obtain the data.

How to obtain:
Request should be sent through an email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Sadeghi-Demneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>sadeghi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Sadeghi-Demneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>sadeghi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Positive ulnocarpal stress sign
Ulnar side wrist pain because of ulnocarpal abutment syndrome</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking NSAIDs medications
Corticosteroid injection
History of wrist and forearm fracture
Receiving concurrent treatments for the lesion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of nerves at wrist and hand level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The short cockup splint made from thermoplastic sheet. This rigid splint covers the volar surface of the hand from the proximal palmar crease to two-third of forearm area. Thumb freely moves in this splint. This splint is custom made for each participant. Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.</i_keyword>
      <i_keyword>Intervention group: The hinged ulnar gutter splint consists of two thermoplastic bars placed on the hand and forearm area. This splint fits over ulnar side of the hand and prevents the ulnar deviation of the wrist. The sagital motions of the wrist and thumb movements are not restricted. This splint is custom made for each participant.  Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.</i_keyword>
      <i_keyword>Control group: The elastic wrist support which covers the middle area of the forearm to palmar surface of the hand and does not apply any mechanical restriction for motions in the hand and forearm.This splint is custom fitted for each participant.  Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving interventions. Method of measurement: Pain intensity will be measured using visual analogue scale. Participants indicate their pain level on a 10 cm scale.</prim_outcome>
      <prim_outcome>Range of motions at the wrist. Timepoint: All interventions will be done in a session and outcomes will be measured 10 minutes after receiving interventions. Method of measurement: The passive range of motion will be measured using a digital goniometer.</prim_outcome>
      <prim_outcome>The wrist weight bearing tolerance. Timepoint: All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving trial interventions. Method of measurement: Participants push on a weight recording scale with the palmar surface of the hand.</prim_outcome>
      <prim_outcome>Hand grip strength. Timepoint: All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving trial interventions. Method of measurement: Hand grip on the involved side will be measured using a digital handgrip dynamometer.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-27</approval_date>
        <contact_name>Ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran</contact_name>
        <contact_address>Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
