<?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>IRCT20180728040618N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needling on hamstring muscles stiffnss and strength of hamstring muscles</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dry needling on hamstring muscles stiffnss and isometric strength of hamstring muscles using an isokinetic dynamometer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Random allocation will be done by the method of variable blocks, which includes blocks of 4 letters and is made of letters A and B. Then, the random treatment list, which will be obtained at the end of the randomization task, will be placed in the form of letters A and B inside sealed and numbered envelopes (the letter A represents dry needling and the letter B represents dry needling placebo). The process of random allocation will be done by a person outside the research team and before the start of the study. After the initial evaluation of the person by the examiner, numbered envelopes, corresponding to the sequential number of each person included in the study, will be given to him.Finally, after each patient enters the therapy sessions, the therapist will adjust the therapeutic interventions based on the letters inside the envelope. Also, it should be mentioned that after placing people in the desired group, they are asked not to share their grouping information with the examiner in order to prevent data contamination, Blinding description: The evaluation and treatment stages will be performed by two different physiotherapists and the evaluator will be impartial to the interventions to avoid bias. Individuals in the dry needle placebo group will receive a placebo and will be unaware of their grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Adaptive hamstring shortening.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: dry needling; This technique is performed by a physiotherapist who has an official certificate of dry needling courses from the Iranian Physiotherapy Association. The Deep dry needling method is performed using disposable stainless steel needles (0.3 x 60 mm; SMC, Seoul, Korea). People are placed on the treatment bed lying on their stomachs with their feet outside the edge of the bed. The hamstring muscles are needled in 4 places, each for 1 minute, with the fast in-out cone-shape technique, and then the needles remain in place for 20 minutes as recommended by Hong. People receive dry needling for 4 sessions. Two of the sites are in the long and short heads of the biceps femoris muscle at a point of 30% and 60% of a straight line from the ischial tuberosity to the fibular head. For Tendinous Tendinous and Membranous Tendon muscles, the dry needling site was selected at two points at 30% and 60% of a straight line from the ischial tuberosity to the medial epicondyle of the femur. Intervention 2: Control group: dry needling placebo; The dry needling placebo method is similar to the original method, that is, all the steps, including how to position the person, how to perform the technique, and cleaning the desired area, are fully implemented, but the needle is inserted subcutaneously and does not enter deeper tissues. Then it remains in place for 20 minutes.</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:
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary.

When:
Starting 6 months after publication

To whom:
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders

Conditions:
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of dry needling.

Where to obtain:
Applicants can contact the researcher of this study zahrasadat mirkhalili by email. Email address: zahra.mirkhalili@gmail.com

How to obtain:
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Holakoo Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665-354</zip>
        <telephone>+98 21 86709</telephone>
        <email>Mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Holakoo Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665-354</zip>
        <telephone>+98 21 86709</telephone>
        <email>Mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of 18 to 35 years.
Adaptive hamstring shortening ≥20° in the passive knee extension test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Needle phobia.
Orthopedic or neurological diseases in the lower limbs.
Back pain
History of back pain in the past year.
History of back, thigh, knee and ankle surgery
Recent hamstring injury.
Pregnancy
People who have coagulopathy or take anti-coagulant drugs.
People who have a history of using dry needles.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Contracture of muscle, thigh</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: dry needling; This technique is performed by a physiotherapist who has an official certificate of dry needling courses from the Iranian Physiotherapy Association. The Deep dry needling method is performed using disposable stainless steel needles (0.3 x 60 mm; SMC, Seoul, Korea). People are placed on the treatment bed lying on their stomachs with their feet outside the edge of the bed. The hamstring muscles are needled in 4 places, each for 1 minute, with the fast in-out cone-shape technique, and then the needles remain in place for 20 minutes as recommended by Hong. People receive dry needling for 4 sessions. Two of the sites are in the long and short heads of the biceps femoris muscle at a point of 30% and 60% of a straight line from the ischial tuberosity to the fibular head. For Tendinous Tendinous and Membranous Tendon muscles, the dry needling site was selected at two points at 30% and 60% of a straight line from the ischial tuberosity to the medial epicondyle of the femur.</i_keyword>
      <i_keyword>Control group: dry needling placebo; The dry needling placebo method is similar to the original method, that is, all the steps, including how to position the person, how to perform the technique, and cleaning the desired area, are fully implemented, but the needle is inserted subcutaneously and does not enter deeper tissues. Then it remains in place for 20 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle-tendon unit stiffness. Timepoint: Before the intervention, after the third session and one week after the third session. Method of measurement: The values ​​of the slope of the regression line calculated from the torque-angle relationship using the least square method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion of passive knee extension test. Timepoint: Before the intervention, after the third session and one week after the third session. Method of measurement: Isokinetic dynamometer.</sec_outcome>
      <sec_outcome>حداکثر گشتاور غیرفعال. Timepoint: Before the intervention, after the third session and one week after the third session. Method of measurement: Isokinetic dynamometer.</sec_outcome>
      <sec_outcome>Maximum voluntary isometric contraction strength. Timepoint: Before the intervention, after the third session and one week after the third session. Method of measurement: Isokinetic dynamometer.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-02</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
