<?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>IRCT20230205057325N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Dry Cupping with Ultrasound in treatment of Chronic Neck Pain</public_title>
      <acronym>MPS (Myofascial Pain Syndrome)</acronym>
      <scientific_title>Effects of High-Power Static Ultrasound Combined with Dry Cupping Therapy on Pain Level and Functions in Patients with Myofascial Trigger Points in Trapezius: A Comparative Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each participant has the opportunity to choose the intervention group randomly by pick up a small paper on which the name of the intervention will be written, Blinding description: the data analyser will be blinded from the specific results of each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Neck Pain for more than 3 months..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: high power static ultrasound + dry cupping + standard medical care. High power static ultrasound technique will be applied according to the following settings: 1 MHz frequency, 1.5 W/cm2 intensity, for 2 minutes on each point (Less than 10 points). Standard medical care including 7 minutes of superficial heat (hot pack) at a temperature of 65.5 °C, 20 minutes of pulsed mode TENS with a duration of 100–110 μs, and a frequency of 70–80 Hz, symmetrical with 4 electrodes and Upper trapezius stretching exercises. Intervention 2: Intervention group 2: Dry cupping, plastic cups with medium power of suction will be applied on injured area by 4-10 glasses with sizes of cup 25 to 50 mm, 10 to 15 min on the trigger points for each cup. Intervention 3: Control group: Standard medical care including 7 minutes of superficial heat (hot pack) at a temperature of 65.5 °C, 20 minutes of pulsed mode TENS with a duration of 100–110 μs, and a frequency of 70–80 Hz, symmetrical with 4 electrodes and Upper trapezius stretching exercises.</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 it is undecided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nassab Ibrahim Toufayli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ras al nabeh, shokeir Blvd</address>
        <city>Beirut Nabatieh</city>
        <country1>Lebanon</country1>
        <zip>no one</zip>
        <telephone>+961 71 545 368</telephone>
        <email>nassabtoufayli@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>Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>no one</zip>
        <telephone>+98 912 107 9244</telephone>
        <email>s_bashardoust@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Lebanon</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with chronic nonspecific neck pain following palpable trigger points for more than 3 months.
Age 25-50 years from both genders.
Patients with neck pain that is scored 30 mm out of 100 mm or greater on the VAS during activity.
Presenting unilateral (or bilateral) trapezius myofascial trigger points (3 to 6) for more than 3 months with an intensity disturbing normal daily activity.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic disorder or migraine
Patients on medication for trigger points or physiotherapy treatment in the previous 3 weeks prior to the study
Pregnant women
Have had any trauma to the neck in the last 6 months
Skin Inflammation
Skin Lesion
Open Wounds
Patients who refused to continue the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>neck pain</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>neck pain, myofascial pain syndrome, dry cupping, high power static ultrasound, trigger points</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: high power static ultrasound + dry cupping + standard medical care. High power static ultrasound technique will be applied according to the following settings: 1 MHz frequency, 1.5 W/cm2 intensity, for 2 minutes on each point (Less than 10 points). Standard medical care including 7 minutes of superficial heat (hot pack) at a temperature of 65.5 °C, 20 minutes of pulsed mode TENS with a duration of 100–110 μs, and a frequency of 70–80 Hz, symmetrical with 4 electrodes and Upper trapezius stretching exercises.</i_keyword>
      <i_keyword>Intervention group 2: Dry cupping, plastic cups with medium power of suction will be applied on injured area by 4-10 glasses with sizes of cup 25 to 50 mm, 10 to 15 min on the trigger points for each cup.</i_keyword>
      <i_keyword>Control group: Standard medical care including 7 minutes of superficial heat (hot pack) at a temperature of 65.5 °C, 20 minutes of pulsed mode TENS with a duration of 100–110 μs, and a frequency of 70–80 Hz, symmetrical with 4 electrodes and Upper trapezius stretching exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain at rest. Timepoint: before intervention, after 2 weeks and after intervention (after 4 weeks). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain at movement. Timepoint: before intervention, after 2 weeks and after intervention (after 4 weeks). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: before intervention, after 2 weeks and after intervention (after 4 weeks). Method of measurement: universal goniometer.</prim_outcome>
      <prim_outcome>Functional capacity. Timepoint: before intervention, after 2 weeks and after intervention (after 4 weeks). Method of measurement: Functional Capacity Evaluation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck disability. Timepoint: before intervention, after 2 weeks and after intervention  (after  4 weeks). Method of measurement: Neck Disability Index.</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>Nassab Physio Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-19</approval_date>
        <contact_name>Ethics committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran </contact_name>
        <contact_address>Quds town (west), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
