<?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>IRCT20220401054381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Dry Needling and Kinesio taping for the treatment of Individuals with hamstring tightness.</public_title>
      <acronym>Kinesio tape (KT) Dry needling (DN)</acronym>
      <scientific_title>Comparison of Immediate Effectiveness of Dry Needling Versus Kinesio taping on Hamstring Muscles Flexibility, Range of Motion and Performance in Individuals with Hamstring Muscles Tightness, A Randomized Controlled Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66614</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the baseline assessment, the participants will be randomized into one of the two intervention groups using simple randomization procedure. Thirty-four cards will be collected inside a ball without any clinical involvement in the study to ensure allocation concealment. A computer generated list of random number will be used. 
Receptionists who is impartial will dispense to either Dry needle or Kinesio Tape according to a computer generated randomization list includes the sequential numbers using an online randomization website (https://www.graphpad.com/quickcalcs/randomize1.cfm). 
Each number and it's allocate group will be written on a piece of paper and will be concealed in an opaque envelope. The receptionist will inform the therapist about patients’ allocation according to the selected index card after the baseline measurements will be taken, Blinding description: As already mentioned, the study is double blinded. The physiotherapist performing the baseline evaluations is blinded to the group the participant belongs to (assessor blind). The physiotherapist performing the post treatment evaluation is blinded to which group the patient belonged to. The data analyzer is also unaware of which study group the data belongs to. After recruitment and random allocation into their groups, the participants read and sign the consent form.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hamstring muscles shortness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will receive dry needling treatment (0.30mm˟50 mm, Huan-Qiu, China) on 1 randomly picked limb where needle is inserted in the muscle at three different points on (A) Long head of biceps femoris, (B) Short head of biceps femoris, (C) Semitendinosus and semimembranosus. An appropriate dry needle will be inserted at the above mentioned points using the 30 seconds of Pistoning and 5 minute in situ followed by static stretching. Intervention 2: Intervention group: Group B will receive Inhibitory Kinesio taping on 1 limb picked randomly where hamstring muscle tape is applied from hamstring muscles insertion to origin (distal to proximal). A 15-25% stretch is used for inhibition techniques using a Y-strip application of the kinesio Tex tape( Kinesio® tape, Kenzo Kase, Japan) followed by static stretching.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 3 months after the articles are published.

To whom:
For researchers working in academic, scientific and hospital institutions and clinicians.

Conditions:
Researchers and clinicians working on musculoskeletal disorders and sports physical therapy.

Where to obtain:
Applicants for documentation can contact Dr. Sara Fereydoonnia via email. s-fereydounnia@sina.tums.ac.ir

How to obtain:
Once they have the necessary criteria, the information will be provided to them within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Fereydounnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche- Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>s-fereydounnia@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohsen Mir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche- Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>smmir@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Normal Male Individuals.
Hamstring length deficit of more than 20 degrees as measured by passive knee extension 90/90 test.
Age must be between 18 to 45 years old.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Surgical history of the lower limb
Allergy to kinesio tape
Seizure
Bleeding disorders
Fractures of the lower limb
Congenital deformities
Trauma
Neurological disorders
Inflammatory skin diseases
Immunodeficiency’s
Consuming anticoagulant
Metal allergies
Radiculopathies
Reluctance to participate and withdrawal from the study at any time</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A will receive dry needling treatment (0.30mm˟50 mm, Huan-Qiu, China) on 1 randomly picked limb where needle is inserted in the muscle at three different points on (A) Long head of biceps femoris, (B) Short head of biceps femoris, (C) Semitendinosus and semimembranosus. An appropriate dry needle will be inserted at the above mentioned points using the 30 seconds of Pistoning and 5 minute in situ followed by static stretching.</i_keyword>
      <i_keyword>Intervention group: Group B will receive Inhibitory Kinesio taping on 1 limb picked randomly where hamstring muscle tape is applied from hamstring muscles insertion to origin (distal to proximal). A 15-25% stretch is used for inhibition techniques using a Y-strip application of the kinesio Tex tape( Kinesio® tape, Kenzo Kase, Japan) followed by static stretching.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Active straight leg raising range of motion. Timepoint: Before intervention and immediately after the intervention. Method of measurement: Participants will be positioned in supine position and will be instructed to flex the hip when knee is in extended position as much as possible. Hip flexion range of motion will be measured by a universal handheld goniometer. The axis, moving arm, and stable arm of the goniometer will be placed on greater trochanter of the femur, parallel to the femur, and parallel to the trunk, respectively.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Passive knee extension test. Timepoint: Before intervention and immediately after the intervention. Method of measurement: Subjects will be asked to lie in supine position and flex the intended hip till 90˚ hip flexion. Contralateral limb will be positioned in extended position. Another clinician extends the knee gradually until reaching the maximal tolerable stretch of the hamstring muscle as indicated by the patient with the ipsilateral hip remaining in 90 degrees of flexion. Knee extension range of motion will be measured by a universal handheld goniometer. The axis, moving arm, and stable arm will be placed over the knee joint, parallel to shin, and femur, respectively.</sec_outcome>
      <sec_outcome>Perceived hamstring tightness. Timepoint: Before intervention and immediately after the intervention. Method of measurement: The participants will be asked to rate their perceived level of hamstring tightness by using a visual analogue scale of 100mm that has two ends. One end of the scale is 0mm representing no tightness or pain and the other end will be at 100mm representing maximum pain or tightness. The subjects will be asked to rate the pain on stretch on the scale when a therapist extends the knee passively while the other limb is stabilized on the table.</sec_outcome>
      <sec_outcome>Modified sit and reach test. Timepoint: Before intervention and immediately after the intervention. Method of measurement: Participants will be asked to sit with their back against a solid wall and fix the feet against the sit and reach box and their arms stretched out to mark the starting position. When the intended knee is in extended position, and contralateral knee placed in slightly flexed position, participants will be asked to reach forward as much as possible.</sec_outcome>
      <sec_outcome>Y-balance test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Y-balance test will be performed in standing position. The subject stands on one leg while reaching out in 3 different directions (anterior, posteromedial and posterolateral) on measuring tapes stuck to the floor. The data acquired will be normalized based on the obtained values of the participants’ lower limb length, height and BMI.</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>2022-10-25</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
