<?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>IRCT20220410054479N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-14</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating effects of extracorporeal shockwave therapy on hamstring tightness and comparing it with dynamic soft tissue mobilization in basketball players</public_title>
      <acronym></acronym>
      <scientific_title>Investigating effects of extracorporeal shockwave therapy on hamstring tightness and comparing it with dynamic soft tissue mobilization in basketball players aged 15 to 18 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63462</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the fact that patients are added to the study over time and not all cases are available at the same time, in order to perform randomization, each eligible patient is assigned to one of the two groups by lottery, Blinding description: Due to the difference in intervention in each of the two groups, the investigator are aware of the type of intervention in each group. But the participant, the outcome assessor, and the Data analyser will not have any knowledge of the type of intervention in each group.</study_design>
      <phase>2</phase>
      <hc_freetext>Hamstring muscle tightness.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group:  In this group, participants will undergo dynamic soft tissue mobilization by an experienced physiotherapist for 4 weeks, three sessions per week. In this group, the patient will take a prone sleeping position, the therapist will be placed on the side of the desired muscle, and the following actions will be performed in sequence. Longitudinal strokes will be applied to the entire hamstring muscle to determine the specific point of muscle titans. Once the desired point is determined, the rest of the treatment will be limited to this point. The patient will then shift to a supine position and will flex the hip and knee 90 degrees. Deep longitudinal strokes will be applied from the distal to the proximal in the direction of the titans point while the foot will be passively extended. Subsequently the progressive and dynamic technique will be performed. In this technique, the patient will actively extend the leg to activate deep muscle inhibition. In the final stage, the hamstring muscle must be contracted eccentrically by the therapist's hand, despite the resistance created. At this stage, the muscle is stretched to the end of the range of motion. During this movement, 5 deep blows are applied from the distal to the proximal on the tight point. Intervention 2: The second intervention group: In this group, participants will undergo extracorporeal shock wave (ESWT) on hamstring muscles in prone position for 4 weeks, one session per week.  The ESWT device is the DUOLITH SD1 model made by STORZ MEDICAL AG. A total of 2,000 impulses will be delivered to the hamstring muscles by the radial head. Of the mentioned impulses, 1,000, 500, and 500 impulses will be for the long head of the biceps femoris, the semitendinosus muscle, and the semimembranosus muscle, respectively. All impulses will enter the middle of these muscles. The repetition frequency of the shock wave will be 15 Hz.</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>Shila Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amin Hospital, Department of Physical Medicine</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8148653141</zip>
        <telephone>+98 31 3445 5051</telephone>
        <email>haghighatshila@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shila Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amin Hospital, Department of Physical Medicine</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8148653141</zip>
        <telephone>+98 31 3445 5051</telephone>
        <email>haghighatshila@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 15 to 18 years
Having at least two years of playing basketball and at least 3 sessions per week
Referral with the main complaint of posterior femoral hamstring tightness or limitation of the active knee extension angle (AKEA) below 170 degrees of knee extension
Consent to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Positive slump test
The history of hip and knee fractures
The history of femoral bone fracture
Existence of internal fixators such as screws and plates
Acute hamstring injury
The history of back pain in the last three months
Complaints of pain and injury to the knee and hip joints
Tightness in the knee joint
The coagulation disorder / acute infection / pregnancy / malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acquired deformities of musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group:  In this group, participants will undergo dynamic soft tissue mobilization by an experienced physiotherapist for 4 weeks, three sessions per week. In this group, the patient will take a prone sleeping position, the therapist will be placed on the side of the desired muscle, and the following actions will be performed in sequence. Longitudinal strokes will be applied to the entire hamstring muscle to determine the specific point of muscle titans. Once the desired point is determined, the rest of the treatment will be limited to this point. The patient will then shift to a supine position and will flex the hip and knee 90 degrees. Deep longitudinal strokes will be applied from the distal to the proximal in the direction of the titans point while the foot will be passively extended. Subsequently the progressive and dynamic technique will be performed. In this technique, the patient will actively extend the leg to activate deep muscle inhibition. In the final stage, the hamstring muscle must be contracted eccentrically by the therapist's hand, despite the resistance created. At this stage, the muscle is stretched to the end of the range of motion. During this movement, 5 deep blows are applied from the distal to the proximal on the tight point.</i_keyword>
      <i_keyword>The second intervention group: In this group, participants will undergo extracorporeal shock wave (ESWT) on hamstring muscles in prone position for 4 weeks, one session per week.  The ESWT device is the DUOLITH SD1 model made by STORZ MEDICAL AG. A total of 2,000 impulses will be delivered to the hamstring muscles by the radial head. Of the mentioned impulses, 1,000, 500, and 500 impulses will be for the long head of the biceps femoris, the semitendinosus muscle, and the semimembranosus muscle, respectively. All impulses will enter the middle of these muscles. The repetition frequency of the shock wave will be 15 Hz.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Active knee extension angle. Timepoint: Immediately and one month after the intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Popliteal angle. Timepoint: Immediately and one month after the intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Performance and balance. Timepoint: Immediately and one month after the intervention. Method of measurement: Y balance test.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-13</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
