<?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>IRCT20200611047734N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-19</date_registration>
      <primary_sponsor>university of Lahore, Lahore</primary_sponsor>
      <public_title>Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51081</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Parallel groups, single blinded, single setting, Randomization description: All the participants who will come to the physiotherapy department will be considered and screen for nonspecific neck pain. 50 patients will be allotted in two groups i.e.; group A(routine physiotherapy) and group B(TMJ exercise+ routine physiotherapy) via lottery method, 25 in each group. patients with having lottery number with group A treated with just baseline treatment of physiotherapy, and patient having lottery method with Group B managed with baseline treatment and also receive a additional technique that was TMJ exercise, Blinding description: it will be a single-blind study in which participant/ patients will be kept blind for treatment technique. 2 different technique will be provided to patients. and they will blind about that which technique will be given to which patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nonspecific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (Routine Physiotherapy): -                    Hot pack + TENS+ neck isometrics exercises.                 Dosage: - o	Hot pack for 20 minutes  o	TENS= 100Hz, 50 µ s pulse, 20 minutes.o	Isometrics Neck exercise = 10 times repetition . Intervention 2: Intervention group:  Group B (Jaw Exercises + Routine Physiotherapy): -                    Hot pack + TENS+ jaw exercises + neck isometrics exercises.                 Dosage: - o	Hot pack for 20 minutes  o	TENS= 100Hz, 50 µ s pulse, 20 minutes.o	Jaw exercises: - 10 times repetitiono	Isometrics Neck exercise = 10 times repetition .</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:
Effects of Temporomandibular joint exercises on pain, range of motion and functional disability in patient with non-specific neck pain

When:
study is completed and become available after its publication

To whom:
person in academic institute. Patient data will not be shown

Conditions:
under the usage with terms in which journal is accessed /processed for publication it could be used in request.

Where to obtain:
+923367595206 from the University office and Responsible supervisor and from journal we will process in future

How to obtain:
can be on call or mail It will be only used in confidential way for improving research and benefit of humanity

Comments:
data can bee provided on request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Rizwan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Raiwind road lahore</address>
        <city>LAHORE</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 42 32591427</telephone>
        <email>rizwanakhter66@gmail.com</email>
        <affiliation>university of Lahore, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Waqar Afzal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Raiwind road lahore</address>
        <city>LAHORE</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 42 32591427</telephone>
        <email>Waqarafzal621@gmail.com</email>
        <affiliation>university of Lahore, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18-55 years old
With primary complaints of NSNP (symptoms lasting for at least 3 months)
One of the four signs of TMD (joint sounds, deviation during mouth opening, muscle pain at a minimum of two tender points in the temporalis or masseter muscles and pain during mouth opening).
Both male and female patients
The severity of pain should be adequate (on a numerical pain rating scale it should be higher than 2 out of 10) for approving a clinically beneficial effect to be exhibited</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute muscle trauma,
Received physiotherapy during the previous 3 months
Unilateral and bilateral upper extremity symptoms
Any neurological disorders.
Musculoskeletal systemic disease
Serious spinal pathology
Thoracic outlet syndrome
Cervical rib
Cervicogenic headache and vertigo.
The previous history of whiplash trauma, prior to 6 weeks of inspection
.Patients with h/o fractures of cervical or thoracic spine
Any former h/o cervico-thoracic surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M43.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spondylolysis, cervical region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A (Routine Physiotherapy): -                    Hot pack + TENS+ neck isometrics exercises.                 Dosage: - o	Hot pack for 20 minutes  o	TENS= 100Hz, 50 µ s pulse, 20 minutes.o	Isometrics Neck exercise = 10 times repetition .</i_keyword>
      <i_keyword>Intervention group:  Group B (Jaw Exercises + Routine Physiotherapy): -                    Hot pack + TENS+ jaw exercises + neck isometrics exercises.                 Dosage: - o	Hot pack for 20 minutes  o	TENS= 100Hz, 50 µ s pulse, 20 minutes.o	Jaw exercises: - 10 times repetitiono	Isometrics Neck exercise = 10 times repetition .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Baseline and after 4th week. Method of measurement: Numeriac pain rating scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Baseline and after 4th week. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Functional activity. Timepoint: Baseline and after 4th week. Method of measurement: Neck Functional Disability index.</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>university of Lahore, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-06</approval_date>
        <contact_name>Institutional Review Board</contact_name>
        <contact_address>Raiwind road lahore LAHORE Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
