<?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>IRCT20230604058379N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Dry Needling with Electrical Stimulation in The Treatment Subacute Neck Pain</public_title>
      <acronym>MPS (Myofascial Pain Syndrome)</acronym>
      <scientific_title>Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain following Myofascial Trigger Points</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70510</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use a simple lottery method for the random allocation of patients into the treatment and control groups. Equal size allocation will be done in this study. All the patients will be given a unique number after screening and then the numbers will be written on small papers of equal size. After that, all the papers will be put in a box and shuffled. For the treatment group, one slip will be taken out by the patient and handed over to the therapist. The same procedure will be used for control group allocation. This sequence will be repeated till all the patients will be allocated into groups, Blinding description: In this open-label study, the physiotherapist was not blind to the groups. However, both the participants and the assessor would be blinded to the treatment protocols. The participants will also get verbal explanations of the study's purpose and the procedures that would be applied before any intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subacute Neck Pain for more than 3 weeks.</hc_freetext>
      <i_freetext>Intervention group: The participants will be randomly allocated into two groups:Group-1 The patients will be under the application of [Dry needling with hot pack] Group -2 The patients will be under the application of [Electrical Dry needling with hot pack [ All participants were lying in prone position and did receive standard medical care including 7 minutes of superficial heat (hot pack) before and after applying Dry needling. The period between hot pack and dry needling was about 3 min. Each protocol of intervention consists of 6 sessions for 3 weeks (2 sessions per week). The participants should not take any other treatment during research time. They must also follow the routine life without any extra activities such as sewing, typing, etc..</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 Currently we are working on streamlining the project and data collection. After recruiting the participants we may be able to deidentify individual data sets.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali hasan hadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al atbaa</address>
        <city>Karbala</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 781 530 7009</telephone>
        <email>nangy489@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Siamak Bashardoust Tajali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enqhelab squar , Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000</zip>
        <telephone>+98 912 107 9244</telephone>
        <email>s_bashardoust@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both genders.
The patients must have sub acute neck pain.
The patients must have unilateral neck pain following the myofascial trigger point in the upper quadrant muscles.
Age between 25-45 years.
The patients must present unilateral sub-acute trigger point signs and symptoms from past 22 -84 days.
The number of identified trigger points at the area must be between 5 – 10 and can be specified for all upper quadrant muscles.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients who had a systemic disorder or migraine
The patients were on medication for trigger points or physiotherapy treatment in previous 3 weeks prior to the study
The pregnant women.
The patient had trauma in the neck area during the past 6 months
The patients with skin inflammation
The patients with the pen wounds
The patients who refused to continue the study for any reason
The patients who had needle phobia
The patients who had a bleeding disorder
The patients who had a cognitive disorder
The patients who had tumors or a background of malignancy disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants will be randomly allocated into two groups:Group-1 The patients will be under the application of [Dry needling with hot pack] Group -2 The patients will be under the application of [Electrical Dry needling with hot pack [ All participants were lying in prone position and did receive standard medical care including 7 minutes of superficial heat (hot pack) before and after applying Dry needling. The period between hot pack and dry needling was about 3 min. Each protocol of intervention consists of 6 sessions for 3 weeks (2 sessions per week). The participants should not take any other treatment during research time. They must also follow the routine life without any extra activities such as sewing, typing, etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analog Scale for Pain. Timepoint: Before intervention and after 3 weeks. Method of measurement: The therapist will ask the patient to report their pain using Visual Analog Scale.</prim_outcome>
      <prim_outcome>Range of Motion of Cervical Spine. Timepoint: Before intervention and after 3 weeks. Method of measurement: The therapist will use Bubble Inclinometer to measure the range of motion of the cervical spine.</prim_outcome>
      <prim_outcome>Functional Capacity Evaluation. Timepoint: Before intervention and after 3 weeks. Method of measurement: The therapist will measure the score of functional capacity evaluation.</prim_outcome>
      <prim_outcome>Neck Disability Index. Timepoint: Before intervention and after 3 weeks. Method of measurement: The therapist will measure the score of the Neck Disability Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Before treatment and after 3 weeks. Method of measurement: Neck Disability Index (NDI).</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>2023-05-13</approval_date>
        <contact_name>Ethics committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran</contact_name>
        <contact_address>School of Rehabilitation of Tehran University of MedicalSciences, Piche Shemiran, Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
