<?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>IRCT20200927048859N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-23</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of dry needling effectiveness on temporomandibular joint pain and range of motion</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of dry needling and sham dry needling effectiveness on pain, range of motion and pressure pain threshold in patients with temporomandibular joint dysfunction after dental procedure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process will be done through closed envelopes and block balanced randomization method. First of all, the first physiotherapist considers all possible aabb arrangements and using a random number table, randomly selects 10 blocks and writes their components one after the other. Each of these components will then be placed in a sealed envelope and numbers 1 to 52 will be recorded on the envelope. Since the therapist is not aware of how the groups are assigned until the intervention, the important feature of allocation concealment is observed in this study. On the day of the intervention, the first physiotherapist choose the envelopes one by one and based on that, places the patients in the intervention group and Placebo, Blinding description: The first physiotherapist is blind to the grouping of patients and the second physiotherapist is blind to the data obtained from the assessments of each patient performed by the first physiotherapist. The patient is also blind to which group he or she belongs to. In the control group, a sharp needle-shaped plastic shield is used so that the patient can only feel the sharp object. It should be noted that the patient's eyes are covered in both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain and temporomandibular dysfunction after dental procedure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They are treated with dry needling on masseter, temporalis, internal and external pterygoid muscles. Initially, by touching and pressing the therapist's hand on each muscle, the most sensitive point to touch is found and targeted with a needle. In this way, the special needles enter this sensitive part of the muscle and remain in the muscle for 20 minutes with infrared heat. At first, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the intervention. Intervention 2: Control group: This group is subjected to sham dry needling. Initially, by touching and pressing the therapist's hand in all four muscles of the masseter, temporal, internal and external pterygoid, the most sensitive point to touch is found and targeted by a sharp plastic needle guide to make the patient feel sharp. And infrared heat shines on the face for 20 minutes. Initially, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Measurement data and results obtained from each person can be shared.

When:
Upon completion of the study for 6 months

To whom:
Researchers on similar subjects

Conditions:
To use the results of the study and citation for related studies

Where to obtain:
Email researcher in charge.
Dr Sepideh Paybast, sepideh.paybast@yahoo.com
Physiotherapist Nafiseh Zekri, nafiseh_zekri@yahoo.com

How to obtain:
Your email will be read and answered within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Paybast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.11, Iran building, Akhlaghi St, Sepah Sq, Jomhouri St</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716699845</zip>
        <telephone>+98 25 3355 5455</telephone>
        <email>nafiseh_zekri@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nafiseh Zekri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11 akhlaqi st. Jomhouri Blvd, sepah sq. Qom Iran</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716699845</zip>
        <telephone>+98 25 3355 5455</telephone>
        <email>Nafiseh_zekri@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women 20-50 years old.
Pain and range of motion limitation on one side of the temporomandibular joint who visit the dentist in the past month or a week.
One week interval from the onset of symptoms and limited range of motion following a visit to the dentist with or without medication.
Not performing physiotherapy on the head and neck for the past 12 months.
No scar tissue, infection, wound or inflammation on trigger point area.
Do not use addictive substances and alcohol due to rising pain threshold.
Restriction of mouth opening less than 30 mm or pain with Numeric Rating Scale above 3</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Both side pain
History of clenching while sleeping or night guard using
Temporomandibular joint (TMJ) degenerative disease
Inflammation in mouth
History of TMJ or dental surgery
History of systemic or metabolic disorders, such as metabolic syndrome
Rheumatoid arthritis, atypical fascial pain, neuralgia and fibromyalgia
Instability in chewing structures
Orthodontic treatment
Anticoagulant therapy
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorders</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>Intervention group: They are treated with dry needling on masseter, temporalis, internal and external pterygoid muscles. Initially, by touching and pressing the therapist's hand on each muscle, the most sensitive point to touch is found and targeted with a needle. In this way, the special needles enter this sensitive part of the muscle and remain in the muscle for 20 minutes with infrared heat. At first, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the intervention.</i_keyword>
      <i_keyword>Control group: This group is subjected to sham dry needling. Initially, by touching and pressing the therapist's hand in all four muscles of the masseter, temporal, internal and external pterygoid, the most sensitive point to touch is found and targeted by a sharp plastic needle guide to make the patient feel sharp. And infrared heat shines on the face for 20 minutes. Initially, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain with Numeric Rating Scale. Timepoint: At the beginning of the study, one week and two weeks after the start of the intervention. Method of measurement: Numeric Rating Scale; The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to '10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”).</prim_outcome>
      <prim_outcome>Range of motion of temporomandibular joint. Timepoint: At the beginning of the study, one week and two weeks after the start of the intervention. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Evaluation of sensitivity of trigger points. Timepoint: At the beginning of the study, one week and two weeks after the start of the intervention. Method of measurement: Digital pressure algometer.</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>Qom university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-26</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences</contact_name>
        <contact_address>No.11, Shahid Akhlaghi St, Sepah Sq, Jomhouri St, Qom, Iran Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
