<?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>IRCT20240724062527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-27</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effect of Carpal Bones Mobilization Technique with and without Neurodynamic Technique in Chronic Carpal Tunnel Syndrome Patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Carpal Bones Mobilization Technique with and without Neurodynamic Technique in Chronic Carpal Tunnel Syndrome Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the screened and willing participants will be randomly allocated to two groups (Group A and Group B) by lottery method, Blinding description: Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques or participants of both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal Tunnel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Experimental Group: Carpal Bone Mobilization with neurodynamic Technique Carpal Bone Mobilization Technique (CBMT) is the movement of the individual carpal bones in a posterior anterior (P-A) and an anteroposterior (A-P) direction in relation to the adjacent carpal bone, radius, ulna, or adjacent metacarpal. Participant will be positioned in supine lying in the middle of the couch with the forearm resting on the couch either pronated or supinated. The physical therapist will be stood by the participant’s involved side beyond the hand, facing the participant’s head. For P-A glide, the therapist will be positioned his hand to localize the forces on the carpal bone in such a way that the maximum breadth of the thumb tips will be placed adjacent to each other on the appropriate carpal bone or intercarpal joint; the fingers will be spread over the adjacent area of the hand for stability; and the arms and thumbs will be positioned in a P-A direction. For A-P glide, the thumbs will be contacted the palmar surface of the participant’s supinated hand against the appropriate carpal bone or intercarpal joint; the fingers will be spread over adjacent areas of the hand for stability; and the thumbs and arms will be positioned in an A-P direction . The P-A or A-P movement will be produced by pressure from the therapist’s arms being transmitted through the spring-like action of the thumbs against the appropriate carpal bone or intercarpal joint. The CBMT will be performed in 3 sets with 30 repetitions in each set, keeping a gap of one minute between the sets. (a) P-A glides (b) A-P glides over carpal bones.Tendon Gliding Exercises: Tendon gliding exercises will be carried out by the participants after applying maneuver (CMBT). The participant will be in sitting position on a chair. The exercises involved sliding the flexor tendons of the hand by moving the fingers through the following five discrete positions: straight, hook, first, table top, and straight fist positions .  The exercises will be actively performed by the participants who marinated each position for 7seconds and repeated five times in each set for 3 sets, keeping one-minute rest between sets. It will be performed three times per week. (a)Straight (b) hook (c) fist (d) table top (c) straight fist .Neurodynamic Technique: This maneuver intends to yield an unrestricted gliding movement of the median nerve against the surrounding soft tissues inside the carpal tunnel.The joints will be moved in such a way that stretched the nerve proximally while releasing it distally followed by a reverse combination. For the right side, the participant will be laid supine on a plinth. The therapist will stand in stride standing (right leg in front of the left one) on the right-hand side of the plinth, facing the participant. The participant's arm will be rested on the therapist's right thigh. The therapist's left will be hand held the participant's right hand. The participant's shoulder girdle will be depressed by the therapist by pushing the right hand vertically down the plinth. The participant's shoulder will be then taken into abduction (90") and lateral rotation, the forearm was supinated and wrist, thumb, and fingers will be extended. In this position, concurrent elbow flexion and wrist extension (a) will be alternated dynamically with concurrent elbow extension and wrist flexion (b). The therapist will alter the combination of movements depending on tissue resistance. Speed and amplitude of movement will be adjusted so that it produced no pain. The NT will be performed in 2 sets of 5 minutes each with 1-minute rest between sets. It was performed three times per week for six weeks consecutively. NDT for median nerve (a) elbow flexion with wrist extension (b) elbow extension with wrist flexion. Intervention 2: Experimental Group B: Carpal Bone Mobilization without neurodynamic Technique The participants randomly allocated in Group B will be received the Carpal bone mobilization without neurodynamic technique. Before apply mobilization routine physical therapy consist of heat therapy for 15 minutes will be applied. The application of this mobilization technique or procedure will mirror the methods described earlier.</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 confidentially.

When:
Data will be available after the publication of findings till six moths

To whom:
Fizza Nawaz

Conditions:
For research purpose

Where to obtain:
To the corresponding author of the study, Fizza Nawaz and can contact on +92317 8118181, fizzanawaz1122@gmail.com

How to obtain:
Open access and there is the traditional public data release where anyone can get access to the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fizza Nawaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54590</zip>
        <telephone>+92 317 8118181</telephone>
        <email>fizzanawaz1122@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fizza Nawaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54590</zip>
        <telephone>+92 317 8118181</telephone>
        <email>fizzanawaz1122@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 30-60 years
Both males and females
Patients with Positive Tinnel sign
Patients reporting a Numeric Pain Rating Scale score between 4 and 7cm</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic pathology (i.e Hypothyroidism)
Patients with inflammatory disorder (i.e Rheumatoid arthritis)
Patients with Cervical radiculopathy
Patients with any deformity in hand or wrist
Patients who have undergone carpal tunnel treatment within the past 3 months
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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental Group: Carpal Bone Mobilization with neurodynamic Technique Carpal Bone Mobilization Technique (CBMT) is the movement of the individual carpal bones in a posterior anterior (P-A) and an anteroposterior (A-P) direction in relation to the adjacent carpal bone, radius, ulna, or adjacent metacarpal. Participant will be positioned in supine lying in the middle of the couch with the forearm resting on the couch either pronated or supinated. The physical therapist will be stood by the participant’s involved side beyond the hand, facing the participant’s head. For P-A glide, the therapist will be positioned his hand to localize the forces on the carpal bone in such a way that the maximum breadth of the thumb tips will be placed adjacent to each other on the appropriate carpal bone or intercarpal joint; the fingers will be spread over the adjacent area of the hand for stability; and the arms and thumbs will be positioned in a P-A direction. For A-P glide, the thumbs will be contacted the palmar surface of the participant’s supinated hand against the appropriate carpal bone or intercarpal joint; the fingers will be spread over adjacent areas of the hand for stability; and the thumbs and arms will be positioned in an A-P direction . The P-A or A-P movement will be produced by pressure from the therapist’s arms being transmitted through the spring-like action of the thumbs against the appropriate carpal bone or intercarpal joint. The CBMT will be performed in 3 sets with 30 repetitions in each set, keeping a gap of one minute between the sets. (a) P-A glides (b) A-P glides over carpal bones.Tendon Gliding Exercises: Tendon gliding exercises will be carried out by the participants after applying maneuver (CMBT). The participant will be in sitting position on a chair. The exercises involved sliding the flexor tendons of the hand by moving the fingers through the following five discrete positions: straight, hook, first, table top, and straight fist positions .  The exercises will be actively performed by the participants who marinated each position for 7seconds and repeated five times in each set for 3 sets, keeping one-minute rest between sets. It will be performed three times per week. (a)Straight (b) hook (c) fist (d) table top (c) straight fist .Neurodynamic Technique: This maneuver intends to yield an unrestricted gliding movement of the median nerve against the surrounding soft tissues inside the carpal tunnel.The joints will be moved in such a way that stretched the nerve proximally while releasing it distally followed by a reverse combination. For the right side, the participant will be laid supine on a plinth. The therapist will stand in stride standing (right leg in front of the left one) on the right-hand side of the plinth, facing the participant. The participant's arm will be rested on the therapist's right thigh. The therapist's left will be hand held the participant's right hand. The participant's shoulder girdle will be depressed by the therapist by pushing the right hand vertically down the plinth. The participant's shoulder will be then taken into abduction (90") and lateral rotation, the forearm was supinated and wrist, thumb, and fingers will be extended. In this position, concurrent elbow flexion and wrist extension (a) will be alternated dynamically with concurrent elbow extension and wrist flexion (b). The therapist will alter the combination of movements depending on tissue resistance. Speed and amplitude of movement will be adjusted so that it produced no pain. The NT will be performed in 2 sets of 5 minutes each with 1-minute rest between sets. It was performed three times per week for six weeks consecutively. NDT for median nerve (a) elbow flexion with wrist extension (b) elbow extension with wrist flexion.</i_keyword>
      <i_keyword>Experimental Group B: Carpal Bone Mobilization without neurodynamic Technique The participants randomly allocated in Group B will be received the Carpal bone mobilization without neurodynamic technique. Before apply mobilization routine physical therapy consist of heat therapy for 15 minutes will be applied. The application of this mobilization technique or procedure will mirror the methods described earlier.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Six weeks. Method of measurement: The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes &lt;1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.</prim_outcome>
      <prim_outcome>Functional Status. Timepoint: Six weeks. Method of measurement: The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and overall functional status. The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.  The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Six weeks. Method of measurement: The term 'goniometry' is derived from the Greek words 'gonia' meaning angle and 'metron' meaning measure, therefore goniometry refers to the measurement of angles, which in rehabilitation settings refers to the measurement of angles in each plane at the joints of the body. The neutral zero method (0 to 180- degree system) is the most widely used method. The range of motion of each joint should be measured in isolation, to avoid trick movement (simultaneous movement of another joint) and muscle insufficiency which may alter the reading.</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>None</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-23</approval_date>
        <contact_name>Research Ethics Committee of University of Lahore</contact_name>
        <contact_address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
