<?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>IRCT20210704051785N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-28</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Proprioceptive neuromuscular facilitation exercises with routine physical therapy for  temporomandibular joint disorders</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effects of proprioceptive neuromuscular facilitation in addition to routine physical therapy on pain, range of motion and postural alignment in patients with temporomandibular joint disorders: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: Sealed envelope method will be used for random allocation. 58 sealed envelopes (29 for Group A and 29 for Group B) will be prepared. 29 envelopes will contain letter A, 29 envelopes will contain letter B on a card. Patient will be asked to choose one envelope. Treatment will be given according to treatment group (Group A: control, Group B: experiment), Blinding description: Senior physiotherapist will assess patient before and after treatment. Senior physiotherapist/assessor will be completely blinded about patient allocation group (control/intervention).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Temporomandibular Joint Disorder due to Postural Alignment (Forward Head Posture). Condition 2: Temporomandibular Joint Disorders due to Forward Head Posture.</hc_freetext>
      <i_freetext>Intervention 1: Control group will follow routine physical therapy which include ultrasound\TENS \infrared and stretching\strengthening exercises for 4 weeks(3 session per week) and home exercises for 2 weeks. infrared\TENS\icing apply for 20 mins over temporomandibular joint and ultrasound for 4 min on 3 MHZ frequency. Modalities will b decided according to acute and chronic condition, in acute icing will be used, in chronic condition infrared will be used. TENS/ ultrasound will be used in all patients. Routine strengthening/stretching exercises will be used to strengthen jaw muscles. Exercise no:1 Place your fist below the jaw. Resist downward movement of your chin. Hold it for 10 seconds and relax for 5 seconds. Repeat 10 times; do it 3 times per day. Exercise no:2 Place your two fingers on the left side of the jaw. Resist its movement to the same side.Hold it for 10 seconds and relax for 5 seconds.Repeat 10 times; do it 3 times per day. Repeat on the opposite side.Exercise no:3 Bend your index finger and place the knuckle between your front teeth, hold it for 6 seconds.If your symptoms are not aggravated, increase your opening width to 2 fingers, hold it for 10 seconds. You can continue increasing your opening range and your time by 3 fingers, 20 seconds and 5 repetitions, do it 3 times per day.Exercise no:4 Sit or stand by a mirror.Place the tip of your tongue behind your top teeth. Gently lower your jaw to open your mouth while keeping your tongue in contact with the roof of your mouth. Use the mirror to make sure that you are opening your mouth evenly, and not moving your jaw from side to side. Close your mouth. Repeat 10 times; do it 3 times per day. Exercise will be progressed according to patient condition. range of motion of TMJ and mild stretch at the end of range in 10 rep 3 times a day. Intervention 2: Group B follow routine physiotherapy (except strengthening\stretching exercises) with proprioceptive neuromuscular facilitation (PNF) program, which is compose of 12 sessions over 4 weeks, each session will continue 30 min and follow home exercise plan for 02 week. PNF program will be terminated after 4th week. The PNF program will compose of a total of 08 therapeutic exercises, including the home exercise. In consideration of the alignment of the cervical spine and the pain in the temperomandibular joint, the posture with a wider base of support will be modified to have a narrower one. All exercise programs will be designed based on the PNF basic principles, basic procedures, and philosophy of PNF. The patterns and techniques of PNF will be adapted to the hypothesis of activity limitation. The PNF program, which extends over 4 weeks, took the programs of each week will be adjusted by combining three to four exercise programs. As a result, three sessions will be conducted in each week, and each of these sessions last for 30 min.Contract relax, Combination of isotonic, Stabilizing reversals, and Rhythmic stabilization techniques will be used for elongation of upper cervical extensors, strengthening of infra-hyoid muscles, Increase stability and mobility of mandible in corrected posture of neck. Before the starting of the exercise program, the patient was given with an overall explanation and detailed instructions on deep-breathing. The exercise will be interrupted when the patient reported pain or fatigue to have a 2 to 3 min break. The break will not include in the total duration of 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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarwat Anees</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 303 4846498</telephone>
        <email>sarwatasifmehmood@gmail.com</email>
        <affiliation>Punjab Social Security Health Management Company Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarwat Anees</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif Polyclinic, near Doce Bakers, Railway Road Raiwind</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 303 4846498</telephone>
        <email>sarwatasifmehmood@gmail.com</email>
        <affiliation>Punjab Social Security Health Management Company Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having temporomandibular joint disorders with postural neck alignment
Pre-diagnosed patients referred by dentist and orthotics</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic or local pathology like infectious or vascular disease of orofacial region
Patient using another form of treatment for temporomandibular disorders
Patient using functional appliances
History of frequent open dislocation
Rheumatoid arthritis
Cervical radiculopathies
Osteoarthritis of temporomandibular joint
Peripheral nerve injury</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.6</hc_code>
      <hc_code>M26.60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorders</hc_keyword>
      <hc_keyword>Temporomandibular joint disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group will follow routine physical therapy which include ultrasound\TENS \infrared and stretching\strengthening exercises for 4 weeks(3 session per week) and home exercises for 2 weeks. infrared\TENS\icing apply for 20 mins over temporomandibular joint and ultrasound for 4 min on 3 MHZ frequency. Modalities will b decided according to acute and chronic condition, in acute icing will be used, in chronic condition infrared will be used. TENS/ ultrasound will be used in all patients. Routine strengthening/stretching exercises will be used to strengthen jaw muscles. Exercise no:1 Place your fist below the jaw. Resist downward movement of your chin. Hold it for 10 seconds and relax for 5 seconds. Repeat 10 times; do it 3 times per day. Exercise no:2 Place your two fingers on the left side of the jaw. Resist its movement to the same side.Hold it for 10 seconds and relax for 5 seconds.Repeat 10 times; do it 3 times per day. Repeat on the opposite side.Exercise no:3 Bend your index finger and place the knuckle between your front teeth, hold it for 6 seconds.If your symptoms are not aggravated, increase your opening width to 2 fingers, hold it for 10 seconds. You can continue increasing your opening range and your time by 3 fingers, 20 seconds and 5 repetitions, do it 3 times per day.Exercise no:4 Sit or stand by a mirror.Place the tip of your tongue behind your top teeth. Gently lower your jaw to open your mouth while keeping your tongue in contact with the roof of your mouth. Use the mirror to make sure that you are opening your mouth evenly, and not moving your jaw from side to side. Close your mouth. Repeat 10 times; do it 3 times per day. Exercise will be progressed according to patient condition. range of motion of TMJ and mild stretch at the end of range in 10 rep 3 times a day.</i_keyword>
      <i_keyword>Group B follow routine physiotherapy (except strengthening\stretching exercises) with proprioceptive neuromuscular facilitation (PNF) program, which is compose of 12 sessions over 4 weeks, each session will continue 30 min and follow home exercise plan for 02 week. PNF program will be terminated after 4th week. The PNF program will compose of a total of 08 therapeutic exercises, including the home exercise. In consideration of the alignment of the cervical spine and the pain in the temperomandibular joint, the posture with a wider base of support will be modified to have a narrower one. All exercise programs will be designed based on the PNF basic principles, basic procedures, and philosophy of PNF. The patterns and techniques of PNF will be adapted to the hypothesis of activity limitation. The PNF program, which extends over 4 weeks, took the programs of each week will be adjusted by combining three to four exercise programs. As a result, three sessions will be conducted in each week, and each of these sessions last for 30 min.Contract relax, Combination of isotonic, Stabilizing reversals, and Rhythmic stabilization techniques will be used for elongation of upper cervical extensors, strengthening of infra-hyoid muscles, Increase stability and mobility of mandible in corrected posture of neck. Before the starting of the exercise program, the patient was given with an overall explanation and detailed instructions on deep-breathing. The exercise will be interrupted when the patient reported pain or fatigue to have a 2 to 3 min break. The break will not include in the total duration of exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion of temporomandibular joint(activity limitation test). Timepoint: Range of motion will be measure before and after 6, 12 week of treatment. Method of measurement: Range of motion measure through vernier caliper.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Pain will be measure before and after 6, 12 week of treatment. Method of measurement: VAS scale will be used to measure pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Impairment of body structure and body function test (forward head posture). Timepoint: Different postural angles will be measure before and after 6, 12 week of treatment. Method of measurement: photogrammatory method will be used. A picture will be taken from camera from 2 meter. lines will be drawn by posturescren app to measure sagittal head, cervical line and shoulder angles for postural assessment by the help of posture screen app.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-17</approval_date>
        <contact_name>Ethics committee of The University of Lahore</contact_name>
        <contact_address>Sharif Polyclinic, near Doce Bakers, Railway Road Raiwind Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
