<?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>IRCT20180311039049N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) on the active trigger points of the upper trapezius muscle</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33734</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a sample of 75 people, 25 cards for each intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofascial Trigger Points of the Upper Trapezius Muscle.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this technique is first step to increase blood flow and muscle tissue temperature for 5 minutes, superficial heat will be used and then using the myo-release tool, muscle tissue will be massaged for 5 minutes. The soft tissue mobilization technique is carried out using the myo-release tool No. 1, made in Iran. The tool is made of stainless steel. Immediately after massage, the therapist applies 3 passive stretches for 30 seconds on the muscle and this phase is completed by the 2nd 12th active muscle stretches by the patient herself and in the final stage, the patient performs the shoulder elevation as 2 sets of 15. This technique is performed in 4 sessions and twice a week. Intervention 2: Intervention group: Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week. Intervention 3: Control group:There is no intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Ahmadpour Emshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1407</telephone>
        <email>zeinab.ahmadpour1372@Gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR. Farshad Okhovatian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1407</telephone>
        <email>Farshadokhovatian1965@Gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects between 18 and 40 years
Presence of active trigger points in upper trapezius muscle
Pain at least 30 mm in visual analog scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of whiplash injury
History of head , neck , cervical spine or shoulder surgery
History of cervical radiculopathy
Diagnosed fibromyalgia and myopathy
History of cancer
Pregnancy
Myofascial therapy within the past month
Contraindication of dry needling technique</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this technique is first step to increase blood flow and muscle tissue temperature for 5 minutes, superficial heat will be used and then using the myo-release tool, muscle tissue will be massaged for 5 minutes. The soft tissue mobilization technique is carried out using the myo-release tool No. 1, made in Iran. The tool is made of stainless steel. Immediately after massage, the therapist applies 3 passive stretches for 30 seconds on the muscle and this phase is completed by the 2nd 12th active muscle stretches by the patient herself and in the final stage, the patient performs the shoulder elevation as 2 sets of 15. This technique is performed in 4 sessions and twice a week.</i_keyword>
      <i_keyword>Intervention group: Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.</i_keyword>
      <i_keyword>Control group:There is no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity in the visual scale of pain. Timepoint: Measure the severity of pain in the first session before and after the intervention and the fourth session and fourth week after the end of treatment. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain pressure threshold. Timepoint: Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment. Method of measurement: Digital algometer (Lutron FG-5020).</sec_outcome>
      <sec_outcome>Active cervical contra lateral flexion. Timepoint: Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment. Method of measurement: Goniometry.</sec_outcome>
      <sec_outcome>Neck disability index. Timepoint: Measurement at first session before intervention and the fourth session and fourth week after the end of treatment. Method of measurement: Neck disability index- iranian version questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-13</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
