<?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>IRCT20090301001722N23</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of  physiotherapy methods on symptoms of Carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effects of nerve and tendon gliding exercise, ultrasound and kinesiotaping on clinical outcomes of carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34801</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients  randomly will be divided into three groups by closed envelope method.  The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated  will be opened by participant, Blinding description: In this study, the  investigator will beblind to the results of all pre- and post-treatment evaluations, also all three evaluators will be blind to each other's results and any patient is located in which intervention group. The data analyzer as a statistics consultant will be also blind. It is not possible to blind patients in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ultrasound:  We use pulse ultrasound with a 5 cm probe, frequency of 1 MHz and intensity 1 W / cm2 (1: 4 ratio) for 10 minutes on the anterior part of the wrist (carpal tunnel). Treatment sessions are performed once a day, 5 sessions per week for three weeks. Intervention 2: Intervention group: taping: we use tape with 5 cm wide and 0.5 mm thick. Thetape is kept on the patient for 3 days and after two days rest, the tape is applied again for 3 days. This will be repeated for up to 3 weeks. Intervention 3: Intervention group: Tendon and nerve gliding exercises are performed according to the Totten and Hunter method in 3 sets of 10 exercises per day for three weeks. Intervention 4: Control group: TENS and Infrared: Normal TENS for 20 minutes, infrared for 20 minutes to  the anterior part of the wrist.</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 All rights of this research belongs to TUMS.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Engheleb Ave, Rehabilitation School</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 6586</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammah Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Engheleb Ave, Rehabilitation School</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 6586</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient with mild and moderate carpal tunnel syndrome- age of 20–60 years
have no disorders like Hypothyroidism, Gout, Systemic Lupus Erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, and acromegaly
have no history of using analgesic drugs to relieve CTS over the past two weeks
have no history of wrist fracture and repetitive trauma to the hand
have no history of CTS surgery
not pregnant
have no any orthopedic or neurologic disorders mimicking CTS such as polyneuropathy, cervical radiculopathy, brachial plexopathy,thoracic outlet syndrome
have no corticosteroid injection into the carpal tunnel in the last three months
No physiotherapy for CTS in the past 6 month</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who were not willing to continue the study for any reason.
Allergic sign of kinesio taping
Taking painkiller during  research</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ultrasound:  We use pulse ultrasound with a 5 cm probe, frequency of 1 MHz and intensity 1 W / cm2 (1: 4 ratio) for 10 minutes on the anterior part of the wrist (carpal tunnel). Treatment sessions are performed once a day, 5 sessions per week for three weeks.</i_keyword>
      <i_keyword>Intervention group: taping: we use tape with 5 cm wide and 0.5 mm thick. Thetape is kept on the patient for 3 days and after two days rest, the tape is applied again for 3 days. This will be repeated for up to 3 weeks.</i_keyword>
      <i_keyword>Intervention group: Tendon and nerve gliding exercises are performed according to the Totten and Hunter method in 3 sets of 10 exercises per day for three weeks.</i_keyword>
      <i_keyword>Control group: TENS and Infrared: Normal TENS for 20 minutes, infrared for 20 minutes to  the anterior part of the wrist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before and after therapeutic sessions. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Symptom Severity. Timepoint: Before and after therapeutic sessions. Method of measurement: Boston questionnaire.</prim_outcome>
      <prim_outcome>Functional Status. Timepoint: Before and after therapeutic sessions. Method of measurement: Boston 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz bolvar, Ghods Ave, 6 floor, Tehran University of Medical Science building Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
