xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05971953</url>
    </required_header>
    <id_info>
      <org_study_id>REC/01649Naureena Binte Sayed</org_study_id>
      <nct_id>NCT05971953</nct_id>
    </id_info>
    <brief_title>Muscle Energy Technique on Hamstring Muscle for Trigger Points of Muscle of Mastication</brief_title>
    <official_title>Effect of Muscle Energy Technique on Hamstring Muscle for the Trigger Points of Muscle of Mastication</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this randomized controlled trial is to find the effect of muscle energy technique&#xD;
        for trigger points of muscle of mastication for reducing pain , improving mouth opening and&#xD;
        jaw functional limitations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary muscles of mastication (chewing food) are the temporalis, medial pterygoid,&#xD;
        lateral pterygoid, and masseter muscles. The masticatory muscles are divided into elevator&#xD;
        and depressor groups. The collective term 'hamstrings' refers to four muscles-&#xD;
        semimembranosus (SM), semitendinosus (ST), biceps femoris long head (BFlh) and biceps femoris&#xD;
        short head (BFsh). The hamstring muscles are the major flexors of the knee and also aid hip&#xD;
        extension. Trigger point is classically defined as a hyperirritable spot in the skeletal&#xD;
        muscle that is associated with a hypersensitive palpable nodule in a taut band which is&#xD;
        painful on compression and can give rise to characteristic referred pain, motor dysfunction,&#xD;
        and autonomic phenomena. Latent trigger points located in the muscles can interfere with&#xD;
        muscular movement patterns, cause cramps, and reduce muscle strength. Active MTrPs can be&#xD;
        associated with a reduced range of motion through muscle dysfunction and muscle weakness,&#xD;
        causing orefacial pain, MTrPs in the masticatory muscles may restrict active maximum mouth&#xD;
        opening (MMO).&#xD;
  &#xD;
        It is possible that stretching the hamstring muscles may activate the dorsal periaqueductal&#xD;
        grey area of the midbrain [PAG], and activate descending inhibitory control pathways. It is&#xD;
        known that descending projections from the PAG to the medulla have collateral branches that&#xD;
        terminate in various areas including the upper cervical spinal cord. Convergence of the&#xD;
        nociceptive afferents from the receptive fields of cervical roots C1-C3 and those of the&#xD;
        trigeminal nerve, which include the masseter muscle, occurs in the nucleus caudalis. If&#xD;
        hamstring muscle stretching is capable of activating the PAG, then decreased sensitivity&#xD;
        should affect a greater number of muscles, including the remaining masticatory muscles.&#xD;
  &#xD;
        Muscle energy technique (MET) is a manual technique developed by osteopaths that is now used&#xD;
        in many different manual therapy professions. It is claimed to be effective for a variety of&#xD;
        purposes, including lengthening a shortened or contractured muscle, strengthening muscles, as&#xD;
        a lymphatic or venous pump to aid the drainage of fluid or blood, and increasing the range of&#xD;
        motion (ROM) of a restricted joint. MET may influence pain mechanisms and promote&#xD;
        hypoalgesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 10, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale VAS</measure>
      <time_frame>2 weeks</time_frame>
      <description>The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inch Tape</measure>
      <time_frame>2 weeks</time_frame>
      <description>A measuring tape is a flexible tool used for measuring. It is marked in centimeters and inches.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Jaw Functional Limitation Scale</measure>
      <time_frame>2 weeks</time_frame>
      <description>The JFLS-20 is an organ-specific instrument comprising 3 constructs for assessing functional status of the masticatory system; the 3 scales exhibit properties that are ideal for both research and patient evaluation in patient groups with a range of functional limitations of the jaw.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Trigger Point Pain, Myofascial</condition>
    <condition>Temporomandibular Disorder</condition>
    <arm_group>
      <arm_group_label>Muscle Energy Technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Muscle Energy Technique</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional PT</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Hot pack Ischemic compression</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle Energy Technique</intervention_name>
      <description>They would be receiving treatment as follow:&#xD;
  The patient is instructed to gently attempt to push down on the practitioner's shoulder with the leg against the practitioner's resistance( 75% of his and her available strength). After the relaxation, the muscle is lengthened more aggressively beyond the barrier and held for up to 15 seconds. Frequency: 10 reps for 4 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 20 mins</description>
      <arm_group_label>Muscle Energy Technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional PT</intervention_name>
      <description>They would be receiving conventional treatment as follow:&#xD;
  including hot pack for 10 mins ischemic compression for 60 seconds .Frequency: 5 reps with 60 sec hold for 4 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins</description>
      <arm_group_label>Conventional PT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age group 25 to 50 years..&#xD;
  &#xD;
            2. Diagnosis of trps using the diagnostic criteria:&#xD;
  &#xD;
                 -  Presence of palpable taut band in a skeletal muscle.&#xD;
  &#xD;
                 -  Presence of hypersensitive tendor spot in a taut band&#xD;
  &#xD;
                 -  Spontaneous response of the typical referred pain pattern.&#xD;
  &#xD;
                 -  A local twitch response provided by snapping palpation of taut band.&#xD;
  &#xD;
                 -  Reproduction of the typical referred pain pattern of Trp in response to&#xD;
                    compression.&#xD;
  &#xD;
            3. Reduced mouth opening &lt; 40nm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of fibromyalgia.&#xD;
  &#xD;
            -  History of whiplash injury&#xD;
  &#xD;
            -  History of any surgery in the cranio cervical region&#xD;
  &#xD;
            -  Having under gone any myofacial pain therapy&#xD;
  &#xD;
            -  No lower extremity or low back pathology.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>KINZA ANWAR, MS-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>KINZA ANWAR, MS-OMPT</last_name>
      <phone>+92-3239735427</phone>
      <email>kinza.anwar@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Railway General Hospital</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>KINZA ANWAR, MS-OMPT</last_name>
        <phone>+92-3239735427</phone>
        <email>kinza.anwar@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Naureena Binte Sayed, MS-OMPT*</last_name>
      </contact_backup>
      <investigator>
        <last_name>Naureena Binte Sayed, MS-OMPT*</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>trigger points</keyword>
    <keyword>muscles of mastication</keyword>
    <keyword>hamstring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Temporomandibular Joint Disorders</mesh_term>
      <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05971953
  org study id: REC/01649Naureena Binte Sayed
  nct id: NCT05971953
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this randomized controlled trial is to find the effect of muscle energy technique
        for trigger points of muscle of mastication for reducing pain , improving mouth opening and
        jaw functional limitations.
  The primary muscles of mastication (chewing food) are the temporalis, medial pterygoid,
        lateral pterygoid, and masseter muscles. The masticatory muscles are divided into elevator
        and depressor groups. The collective term 'hamstrings' refers to four muscles-
        semimembranosus (SM), semitendinosus (ST), biceps femoris long head (BFlh) and biceps femoris
        short head (BFsh). The hamstring muscles are the major flexors of the knee and also aid hip
        extension. Trigger point is classically defined as a hyperirritable spot in the skeletal
        muscle that is associated with a hypersensitive palpable nodule in a taut band which is
        painful on compression and can give rise to characteristic referred pain, motor dysfunction,
        and autonomic phenomena. Latent trigger points located in the muscles can interfere with
        muscular movement patterns, cause cramps, and reduce muscle strength. Active MTrPs can be
        associated with a reduced range of motion through muscle dysfunction and muscle weakness,
        causing orefacial pain, MTrPs in the masticatory muscles may restrict active maximum mouth
        opening (MMO).
  
        It is possible that stretching the hamstring muscles may activate the dorsal periaqueductal
        grey area of the midbrain [PAG], and activate descending inhibitory control pathways. It is
        known that descending projections from the PAG to the medulla have collateral branches that
        terminate in various areas including the upper cervical spinal cord. Convergence of the
        nociceptive afferents from the receptive fields of cervical roots C1-C3 and those of the
        trigeminal nerve, which include the masseter muscle, occurs in the nucleus caudalis. If
        hamstring muscle stretching is capable of activating the PAG, then decreased sensitivity
        should affect a greater number of muscles, including the remaining masticatory muscles.
  
        Muscle energy technique (MET) is a manual technique developed by osteopaths that is now used
        in many different manual therapy professions. It is claimed to be effective for a variety of
        purposes, including lengthening a shortened or contractured muscle, strengthening muscles, as
        a lymphatic or venous pump to aid the drainage of fluid or blood, and increasing the range of
        motion (ROM) of a restricted joint. MET may influence pain mechanisms and promote
        hypoalgesia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Visual Analog Scale VAS
  time frame: 2 weeks
  description: The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
  measure: Inch Tape
  time frame: 2 weeks
  description: A measuring tape is a flexible tool used for measuring. It is marked in centimeters and inches.
  measure: Jaw Functional Limitation Scale
  time frame: 2 weeks
  description: The JFLS-20 is an organ-specific instrument comprising 3 constructs for assessing functional status of the masticatory system; the 3 scales exhibit properties that are ideal for both research and patient evaluation in patient groups with a range of functional limitations of the jaw.
  arm group label: Muscle Energy Technique
  arm group type: Active Comparator
  description: Muscle Energy Technique
  arm group label: Conventional PT
  arm group type: Other
  description: Hot pack Ischemic compression
  intervention type: Other
  intervention name: Muscle Energy Technique
  description: They would be receiving treatment as follow:
  The patient is instructed to gently attempt to push down on the practitioner's shoulder with the leg against the practitioner's resistance( 75% of his and her available strength). After the relaxation, the muscle is lengthened more aggressively beyond the barrier and held for up to 15 seconds. Frequency: 10 reps for 4 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 20 mins
  arm group label: Muscle Energy Technique
  intervention type: Other
  intervention name: Conventional PT
  description: They would be receiving conventional treatment as follow:
  including hot pack for 10 mins ischemic compression for 60 seconds .Frequency: 5 reps with 60 sec hold for 4 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins
  arm group label: Conventional PT
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: KINZA ANWAR, MS-OMPT
  role: Principal Investigator
  affiliation: RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
  last name: KINZA ANWAR, MS-OMPT
  phone: +92-3239735427
  email: kinza.anwar@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No