<?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>IRCT20221205056713N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-24</date_registration>
      <primary_sponsor>Rashid Latif Medical college</primary_sponsor>
      <public_title>Effects of nerve mobilization and active release technique in treatment of carpel tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of nerve mobilization and active release technique on pain range of motion and disability in carpel tunnel syndrome patients among pregnant women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67793</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size of study is 34. Participants will allocate in two treatment groups by simple random sampling using lottery method. We will make 100 chits, each with the name of a participant written on it. The chits are placed in a container of some kind, give a good shake, and 30 chits will picked. Those whose names on the chits will selected for the respective treatment, Blinding description: The outcome asesser will not know which participant will allocated in group A or group B. So study will single blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: nerve mobilization technique group, group A will consist of 17 patients which will randomly allocate. Patients will treat with median nerve mobilization and heating pad. The patient will be in sitting position, therapist standing by side of patient to straighten the arm extend the wrist and apply passive pressure on the fingers. Repeat this procedure three times a day (3 sets 10 rep) and two times per week for four weeks. Assessment of patient's symptom will take before and after treatment. Intervention 2: Intervention group: active release technique group, group B will also be included 17 patients. Patients will treated with active release technique and heating pad.The patient may sit or lie supine and therapist stand in front or the patient or at the  side respectively. The therapist thumb is placed on the medial and lateral attachment of the transverse carpel ligament. As the therapist fingers wrap around the dorsal surface of the wrist. The therapist exert the tension on the carpel region ( especially the flexor retinaculum) by pressing the thumb into the volar surface of the base of the thumb and pushing the thumb apart. This position is held for 20-60 sec and then release. 3 set with 5 to 6 repetition will be performed, two times per week. The treatment will be given for 4 week. Assessment of patient's symptom will take before and after treatment.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amna Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-KM, Ferozepur Road. Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 321 1185253</telephone>
        <email>bamna8894@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hafiza Nida Rasheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-KM, Ferozepur Road. Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 336 4535979</telephone>
        <email>naddia.rasheed20@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20-40 years.
Pregnant women with numbness in hands
Subjects with diagnosed carpal tunnel syndrome and related symptoms that scored 3 or worse on the symptom severity and functional status questionnaire</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>If subjects have a history of causes of carpal tunnel syndrome e.g. diabetes mellitus, rheumatoid arthritis, chronic renal failure treated by hemodialysis, sarcoidesis.
If subjects have already been treated with wrist splint or have previous carpal tunnel release surgery</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: nerve mobilization technique group, group A will consist of 17 patients which will randomly allocate. Patients will treat with median nerve mobilization and heating pad. The patient will be in sitting position, therapist standing by side of patient to straighten the arm extend the wrist and apply passive pressure on the fingers. Repeat this procedure three times a day (3 sets 10 rep) and two times per week for four weeks. Assessment of patient's symptom will take before and after treatment.</i_keyword>
      <i_keyword>Intervention group: active release technique group, group B will also be included 17 patients. Patients will treated with active release technique and heating pad.The patient may sit or lie supine and therapist stand in front or the patient or at the  side respectively. The therapist thumb is placed on the medial and lateral attachment of the transverse carpel ligament. As the therapist fingers wrap around the dorsal surface of the wrist. The therapist exert the tension on the carpel region ( especially the flexor retinaculum) by pressing the thumb into the volar surface of the base of the thumb and pushing the thumb apart. This position is held for 20-60 sec and then release. 3 set with 5 to 6 repetition will be performed, two times per week. The treatment will be given for 4 week. Assessment of patient's symptom will take before and after treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptom severity and functional status. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Boston Carpal Tunnel Score questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Numeric pain rating scale will use to measure pain intensity.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before treatment and 4 weeks after treatment. Method of measurement: Goniometer.</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>Rashid Latif Medical college</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-10</approval_date>
        <contact_name>The institutional board of Rashid Latif Medical College, Lahore</contact_name>
        <contact_address>35KM Ferozepur Road, Lahore. Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
