<?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>IRCT20250222064806N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-07</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of concurrent myofascial release of the shoulder girdle and hand compared to myofascial release of the hand on functional  and electrodiagnostic  parameters of patients with mild and moderate carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of concurrent myofascial release of the shoulder girdle and hand compared to myofascial release of the hand on functional  and electrodiagnostic  parameters of patients with mild and moderate carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82218</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is done by a dice, so that in this 3-group study, numbers 1 and 2 are considered for the first group, numbers 3 and 4 for the second group, and numbers 5 and 6 for the third group, Blinding description: In this study, the evaluator and the therapist are two separate individuals, and the evaluator is blind, so the present study will be single-blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal Tunnel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: concurrent myofascial release of the shoulder girdle and hand                                                                                                                 Myofascial release of the shoulder girdle area is performed on the upper terapezius, pectoralis major, supraspinatus, and subscapularis. The same hand release will be performed on the carpal ligament area of ​​the wrist. The release will last 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Intervention 2: Intervention group: Intervention group2: Hand Myofascial Release                                    Myofascial release will be performed on the carpal ligament area of ​​the wrist. The release will last for 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Intervention 3: Control group: In the control group, only routine physiotherapy is performed. Routine physiotherapy is performed in the form of applying a high-frequency TENS current for fifteen minutes with a frequency of 100 HZ and a diurnance of 100 with an amplitude of 15 mA and 5 minutes with a frequency of 1 HZ and a diurnance of 200 with an amplitude of 5 mA in a two-channel manner on the wrist and palm area.Then, pulsed ultrasound current with a frequency of 1 MHz and an intensity of 0.8 watts/square centimeter will be used for 3 minutes on the carpal ligament area of ​​the wrist. After that, infrared will be used for 15 minutes at a distance of 50 cm.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.</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 "There is no further information."</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9837535196</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>azadehmokhtari27@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9837535196</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>azadehmokhtari27@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 18-50 years old
Mild &amp; moderate idiopathic CTS
VAS above 3</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cervical radiculopathypoly
Polyneuropathy
Diabetes mellitus
Hypothyroidism
Chronic kidney failure
Chronic alcoholism
Acromegaly
Connective tissue disease
Inflammatory diseases
Pregnant
Breast feeding
History of fracture or surgery in the hand
More than 20% absence in practice sessions
Unwillingness to continue</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: concurrent myofascial release of the shoulder girdle and hand                                                                                                                 Myofascial release of the shoulder girdle area is performed on the upper terapezius, pectoralis major, supraspinatus, and subscapularis. The same hand release will be performed on the carpal ligament area of ​​the wrist. The release will last 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.</i_keyword>
      <i_keyword>Intervention group: Intervention group2: Hand Myofascial Release                                    Myofascial release will be performed on the carpal ligament area of ​​the wrist. The release will last for 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.</i_keyword>
      <i_keyword>Control group: In the control group, only routine physiotherapy is performed. Routine physiotherapy is performed in the form of applying a high-frequency TENS current for fifteen minutes with a frequency of 100 HZ and a diurnance of 100 with an amplitude of 15 mA and 5 minutes with a frequency of 1 HZ and a diurnance of 200 with an amplitude of 5 mA in a two-channel manner on the wrist and palm area.Then, pulsed ultrasound current with a frequency of 1 MHz and an intensity of 0.8 watts/square centimeter will be used for 3 minutes on the carpal ligament area of ​​the wrist. After that, infrared will be used for 15 minutes at a distance of 50 cm.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Visual Analog Scale(VAS).</prim_outcome>
      <prim_outcome>Function. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Boston CTS questionnaire.</prim_outcome>
      <prim_outcome>Myofascial Release. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Manual.</prim_outcome>
      <prim_outcome>Nerve Conduction Velocity. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Electrodiagnostic studies with an EMG device.</prim_outcome>
      <prim_outcome>Latency. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Electrodiagnostic studies with an EMG device.</prim_outcome>
      <prim_outcome>Amplitude. Timepoint: After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed. Method of measurement: Electrodiagnostic studies with an EMG device.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-26</approval_date>
        <contact_name>Ethic committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Basij Blvd. Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
