<?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>IRCT20111121008146N38</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-17</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparing Analgesic effect of 808nm low-level laser, dry needing and cupping in the treatment of MPDS</public_title>
      <acronym></acronym>
      <scientific_title>Comparing Analgesic effect of 808nm low-level laser, dry needing and cupping in the treatment of MPDS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62371</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: single-digit random numbers were generated using Excel software. The order of these random numbers was considered as the number of people entering the study. If these numbers were between 1-3, the patient was assigned to the first group, between 4-6 to the second group, between 7-9 to the third group. Following the work of each group, to which 20 patients were assigned, the generated numbers related to that group were removed from the random number production chain, Blinding description: Clinical examination of all patients is performed by another specialized assistant of trained oral diseases under the supervision of neutral professors and the patients' details are recorded based on the information form. Relevant assistants and professors will not know that the patient belongs to the acupuncture and cupping group at any stage of the examination.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myofascial trigger points pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The first group is treated with GA-AL-AS low power diode laser with a wavelength of 808 nm Konftec low power laser device made in Taiwan with a power of 250 ml watts for 60 seconds with a power of 15J and a density of 4 joules per square centimeter It is used at any point of the trigger as a Continuous Wave and the laser irradiation is done in contact with the gentle pressure of the device type with a Spot Size of 3 cubic centimeters in the irradiation area. First, the points of the muscle trigger are identified in the management of the master or temporalis or external trigoid, and then laser irradiation will be performed on the points. The number of treatment sessions will be 3 times a week, one day in between and a total of 8 sessions. Intervention 2: Intervention group: In the second group, treatment with dry needling (Tony brand) made in China with a gauge (0.18 * 13 mm) will be performed on the trigger points. First we find the available trigger points and copy them with a pencil. To find trigger points, touch the muscle with medium to high pressure in all its parts. When the point of the muscle trigger was found, which was actually a relatively hard nodule to the touch, mark the skin of the trigger with a disinfected copy pencil, disinfect the skin with medical alcohol, and treat under the supervision of a professor. We start with a pain specialist and acupuncturist. Insertion of needle is gentle and 5 to 10 mm deep, uniform and intentional. If there is no reaction after the needle enters, the needle should stay in place for 2 to 3 minutes and then be removed. Intervention 3: Intervention group: In the third group of cupping patients, first the muscle trigger points in the master or temporalis or external trigeminal muscles are identified and cupping is performed by an assistant from the oral diseases department under the supervision of a professor and specialist in pain and acupuncture. Cupping does not have a lasting effect on the skin, it only causes temporary redness in some people. This treatment is vacuumed with a 10 cc disposable cup in the desired places with suction or vacuum hand tools to the extent that 1 cm of skin is highlighted under the vacuum inside the cup and stays on the place for 5 minutes with the same amount of negative pressure. It is repeated every other day.</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 is potentially shareable after unidentified individuals

When:
Access period starts 6 months after the results are published

To whom:
Dentists. Oral and maxillofacial surgeons

Conditions:
Email the corresponding author and earn permission

Where to obtain:
Email the corresponding author

How to obtain:
Email the corresponding author, the authors' meeting, send the data at your discretion

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohammad Asnaashari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tehran, Velenjak</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2271 8021</telephone>
        <email>mo_asna12@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Asnaashari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tehran, Velenjak</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2271 8021</telephone>
        <email>mo_asna12@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
The presence of a trigger point in the temporalis or master or external trigeminal muscles that are identified by touch and examination</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking painkillers, muscle relaxants, anti-inflammatory drugs and benzodiazepines
Fear of needles, cupping or lasers
Bleeding disorders
Any underlying diseases such as metabolic (diabetes) and vascular
Neurological disorders (trigeminal neuralgia)
Pregnancy
Receive any treatment for temporomandibular joint disorder</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The first group is treated with GA-AL-AS low power diode laser with a wavelength of 808 nm Konftec low power laser device made in Taiwan with a power of 250 ml watts for 60 seconds with a power of 15J and a density of 4 joules per square centimeter It is used at any point of the trigger as a Continuous Wave and the laser irradiation is done in contact with the gentle pressure of the device type with a Spot Size of 3 cubic centimeters in the irradiation area. First, the points of the muscle trigger are identified in the management of the master or temporalis or external trigoid, and then laser irradiation will be performed on the points. The number of treatment sessions will be 3 times a week, one day in between and a total of 8 sessions</i_keyword>
      <i_keyword>Intervention group: In the second group, treatment with dry needling (Tony brand) made in China with a gauge (0.18 * 13 mm) will be performed on the trigger points. First we find the available trigger points and copy them with a pencil. To find trigger points, touch the muscle with medium to high pressure in all its parts. When the point of the muscle trigger was found, which was actually a relatively hard nodule to the touch, mark the skin of the trigger with a disinfected copy pencil, disinfect the skin with medical alcohol, and treat under the supervision of a professor. We start with a pain specialist and acupuncturist. Insertion of needle is gentle and 5 to 10 mm deep, uniform and intentional. If there is no reaction after the needle enters, the needle should stay in place for 2 to 3 minutes and then be removed.</i_keyword>
      <i_keyword>Intervention group: In the third group of cupping patients, first the muscle trigger points in the master or temporalis or external trigeminal muscles are identified and cupping is performed by an assistant from the oral diseases department under the supervision of a professor and specialist in pain and acupuncture. Cupping does not have a lasting effect on the skin, it only causes temporary redness in some people. This treatment is vacuumed with a 10 cc disposable cup in the desired places with suction or vacuum hand tools to the extent that 1 cm of skin is highlighted under the vacuum inside the cup and stays on the place for 5 minutes with the same amount of negative pressure. It is repeated every other day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain is recorded in the first session of the examination under VAS 1 and then in each treatment session at the beginning of the session before the start of the new treatment phase that day in the relevant schedule. The last amount of pain recording in the follow-up session is done 1 month after the completion of the treatment sessions as VAS 2 or Visit In 1 Month. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>(Maximum mouth opening). Timepoint: In the first session, the examination is called MMO 1 and each session is recorded in the relevant table before starting the treatment. The last MMO registration in the follow-up session is done 1 month after the completion of the treatment sessions as MMO2 or Visit In 1 Mouth. Method of measurement: By calibrated ruler in mm.</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>2022-01-09</approval_date>
        <contact_name>Ethics in Biomedical Research of Shahid Beheshti University of medical sciences</contact_name>
        <contact_address>Daneshjoo Blvd, Yaman street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
