<?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>IRCT20160424027562N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-25</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needling on jumping and pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Immediate and Delayed Effects of Two Methods of Fast in fast out and Winding Dry needling  in Gastrocnemius Muscle Trigger Points on Lower Extremity Function and Pain in Non-professional Athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure that two groups are matched in terms of sex as well as to achieve a complete randomized and balanced assignment, we will use stratified randomization method (layered) by stratified permuted block randomization. So individuals are divided into two stratum of male and female and for each stratum, a separate random assignment is continued until the optimal sample size is reached. For a random assignment in each stratum based on the sequences of the two methods A and B, six blocks are defined as follows and  numbered from 1 to 6 respectively:
AABB- BBAA- ABAB- ABBA- BABA- BAAB

Then, blocks of random numbers are randomly selected by numbers 1 to 6. (numbers 0 and 7 to 9 are not the criteria for the decision). Thus, the type of intervention for each five people is determined respectively. Random allocation software will be used to construct the encryption tag, and then we will use the enclosed packet to hide it randomly, Blinding description: In order to blind the participants, the details of technique will not be explained for them and only the explanation of trigger points treatment by needling will be clarified. Also the individuals of each group will not be informed of the existence of the other group, to achieve this purpose, two groups will be visited on different days to get treatment and record jumping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofascial trigger point.</hc_freetext>
      <i_freetext>Intervention 1: Control group: This group receives the usual dry needling method. Dry needling is applied to the trigger points of the Gastrocnemius muscle by means of a piston method. In this group, initial evaluations and the jumping base are recorded. The next day, the patient finds a dry needling at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length, and the needle enters the trigger point after passing through the skin, then it is removed to close the skin and then into a slightly spaced fan shape  applied on trigger points, This will continue until muscle twitching is seen. After the twitch  muscle is visible, it remains in the trigger point for ten minutes.Then the needle is removed and three jumps are taken from the participant, jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras and the recording frequency  is 100 Hz . Average jumps will be compared with the second intervention group. Intervention 2: Intervention group: This group receives the dry needle rotation method. In this group, initially, initial evaluations and  the jump base are recorded. The next day, the patient finds a dry needle at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length. The needle passes through the skin and enters the trigger points. After insertion of the needle with a frequency of two Hz for 30 seconds in the opposite direction We turn the clock and rest for thirty seconds. It will be repeated for ten minutes. Then the needle is removed and three jumps are taken from the participants,  jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras an The recording frequency  is 100 Hz . Average jumps will be compared with the second intervention group.</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 can be shared after being unidentified.

When:
The beginning of the access period is one month after the results are published.

To whom:
All those who need research results can receive the study documentation.

Conditions:
All people who use the information are required to mention the source

Where to obtain:
To receive the information, they can contact the research author at the Faculty of Rehabilitation, Semnan University of Medical Sciences.

How to obtain:
After receiving the email from the applicant, the applicant will be sent a document within two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghayeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>mohamadipt@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghayeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>mohamadipt@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of fibrous bundle
Touch sensitivity
The presence of local or visible muscle fasciculation in palpation
The presence of pain in the posterior region of leg muscles during walking or running without morning symptoms that can be radicular or constant
Individuals should be athlete and running, jumping, sudden redirect and fast running should be the main components of their sports.
They should practice at least two days a week
Squatting should be part of their training program
The participants should have moderate pain intensity and a VAS of between 3 and 6</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Hypothyroidism
Connective tissue tumor
Anticoagulant drugs
Blood disorders
Local or diffuse infection
Skin lesions, swelling, immune system disorders, vascular dysfunction and fear of dry needling
History of any damage and treatment of vertebral column and lower extremity in the past three months
The presence of 11 to 13 sensitive points that are indicative of fibromyalgia
The presence of painful and sensitive points in other regions of  lower extremity and trunk</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>Control group: This group receives the usual dry needling method. Dry needling is applied to the trigger points of the Gastrocnemius muscle by means of a piston method. In this group, initial evaluations and the jumping base are recorded. The next day, the patient finds a dry needling at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length, and the needle enters the trigger point after passing through the skin, then it is removed to close the skin and then into a slightly spaced fan shape  applied on trigger points, This will continue until muscle twitching is seen. After the twitch  muscle is visible, it remains in the trigger point for ten minutes.Then the needle is removed and three jumps are taken from the participant, jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras and the recording frequency  is 100 Hz . Average jumps will be compared with the second intervention group.</i_keyword>
      <i_keyword>Intervention group: This group receives the dry needle rotation method. In this group, initially, initial evaluations and  the jump base are recorded. The next day, the patient finds a dry needle at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length. The needle passes through the skin and enters the trigger points. After insertion of the needle with a frequency of two Hz for 30 seconds in the opposite direction We turn the clock and rest for thirty seconds. It will be repeated for ten minutes. Then the needle is removed and three jumps are taken from the participants,  jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras an The recording frequency  is 100 Hz . Average jumps will be compared with the second intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vertical jumping. Timepoint: At the beginning of the study, 24, 48, and 72 hours, also four weeks after applying the needle dry technique. Method of measurement: Motion analysis system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: At the beginning of the study, 24, 48, 72, and four weeks after applying the needle dry technique. Method of measurement: Visual  analogue scale.</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>2019-03-16</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
