<?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>IRCT20221008056115N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-26</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Dry needling and Electroacupuncture  on  Myofascial pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Effectiveness of Dry needling and Electroacupuncture of upper trapezius muscle on pain, Ultrasonography changes and Functional disability of Upper limb in patients with Myofascial pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66282</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are assigned (to two groups) randomly and using the method of random permutation blocks with 6 blocks of 6, assigned to the two groups. In this method, A will represent the first intervention group and B will represent the second intervention group. In this way, the order of A and B interventions in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. The supervisor first selects the block using a random number generator (or dice roll) and then the eligible individuals are assigned to one of the two groups A or B. And the sequence of each item will be crossed out. It should be noted that if a block is selected based on random numbers that have already filled all 6 sequences, another random number will be selected again for that person, Blinding description: The researcher will be blind to the intervention by employing the research assistant and not being in the intervention room. The outcome assessor will be different from the researcher and will only receive the study data with a code from the researcher and is not aware of the interlopers. In each group, they are not aware of the intervention of the other group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myofacial pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: Dry needling of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the midpoint of the line extending from the seventh cervical vertebra to the acromion process, on the trigger points, and will remain in the muscle for 15 minutes. Intervention 2: Second Intervention group: Electroacupuncture of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the middle point of the line that extends from the seventh cervical vertebra to the acarion process, on the trigger points, and electroacupuncture with a frequency of 100 Hz is continuously applied for 15 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Zia Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Medical Sciences, Basij Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>ziasafavi@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Zia Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Medical Sciences, Basij Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>ziasafavi@yahoo.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 a tight band and sensitive points to pain
Having a referral pain pattern
People with a body mass index between 20 and 29
At least 3 months have passed since the pain started and no specific reason has been mentioned about the cause of the pain</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>diabetes
pregnancy
Fibromyalgia disease
Needle phobia
Hypersensitivity to needle
History of neck and shoulder surgery
Rheumatoid arthritis and degenerative diseases, myopathy, neuropathy, myelopathy, torticollis, radiculopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Myalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: Dry needling of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the midpoint of the line extending from the seventh cervical vertebra to the acromion process, on the trigger points, and will remain in the muscle for 15 minutes.</i_keyword>
      <i_keyword>Second Intervention group: Electroacupuncture of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the middle point of the line that extends from the seventh cervical vertebra to the acarion process, on the trigger points, and electroacupuncture with a frequency of 100 Hz is continuously applied for 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The thickness of the upper trapezius muscle. Timepoint: Before the intervention and after the intervention. Method of measurement: Ultrasonography device.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before the intervention and after the intervention. Method of measurement: Disability of the Arm, Shoulder and Hand questionnaire.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-10</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 Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
