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/NCT06013644</url>
    </required_header>
    <id_info>
      <org_study_id>17223</org_study_id>
      <nct_id>NCT06013644</nct_id>
    </id_info>
    <brief_title>Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome</brief_title>
    <official_title>Comparative Efficacy of Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox&#xD;
        injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6&#xD;
        months after the intervention&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All the patients will be selected and examine from the outpatient clinic of Oral and&#xD;
        Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.&#xD;
  &#xD;
        Electromyography examination will be conducted in the department of neurophysiology&#xD;
        department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged&#xD;
        from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and&#xD;
        symptoms of pain or muscles spams and examination shows trigger points in masticatory&#xD;
        muscles. selected patients must have not received any other form of surgical treatment&#xD;
        related to TMJ disorders All patients involved in this study will be divided into three&#xD;
        groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry&#xD;
        needle, and Botox injection.&#xD;
  &#xD;
        for both, acupuncture group and dry needling group, patients should receive a session/week&#xD;
        for 4-6 weeks&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 3, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>Early Phase 1</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change of electrical activity of mastication muscles from the baseline measurement</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change of electrical activity of mastication muscles from the baseline measurement</measure>
      <time_frame>6 months after treatment</time_frame>
      <description>change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)</measure>
      <time_frame>6 months after treatment</time_frame>
      <description>change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient Satisfaction questionnaire</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Satisfaction questionnaire</measure>
      <time_frame>6 months after treatment</time_frame>
      <description>Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Myofascial Trigger Point Pain</condition>
    <condition>Myofascial Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>Acupuncture needle (study group A)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry needle (study group B)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Botox injection (study group C)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Acupuncture needle</intervention_name>
      <description>a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2</description>
      <arm_group_label>Acupuncture needle (study group A)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dry needle</intervention_name>
      <description>a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes</description>
      <arm_group_label>Dry needle (study group B)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Botox Injectable Product</intervention_name>
      <description>each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms</description>
      <arm_group_label>Botox injection (study group C)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Accepts Healthy Volunteers&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy Volunteers&#xD;
  &#xD;
            -  MPDS patient&#xD;
  &#xD;
            -  Adult patients of both sexes, aged from 15 to 60 years&#xD;
  &#xD;
            -  signs and symptoms of pain or muscles spams&#xD;
  &#xD;
            -  Trigger points in masticatory muscles&#xD;
  &#xD;
            -  Patients had not received any other form of surgical treatment related to TMJ&#xD;
               disorders&#xD;
  &#xD;
            -  Cooperative patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia&#xD;
  &#xD;
            -  Edentulous patients, and total dental prosthesis.&#xD;
  &#xD;
            -  Psychologically disturbed and mental disturbance patients&#xD;
  &#xD;
            -  major systemic disorders (- Valvular heart disease: avoid indwelling needles)&#xD;
  &#xD;
            -  seizure patients&#xD;
  &#xD;
            -  A confirmed or suspected diagnosis of an inflammatory disorder and autoimmune.&#xD;
  &#xD;
            -  Patient on Medication (insulin- corticosteroids, nonsteroidal anti-inflammatory&#xD;
               therapy or narcotics, muscle relaxants, herbal medicines.)&#xD;
  &#xD;
            -  Analgesic or anti-depressants over the last 2 weeks.&#xD;
  &#xD;
            -  Any anatomical abnormality in TMJ.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Allergies to metals.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Wajma Sayed Karim Al Sayed</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wajma Alsayed</last_name>
        <phone>01004762274</phone>
        <email>wajmah.sayed@dentistry.cu.edu.eg</email>
      </contact>
      <contact_backup>
        <phone>+201001545449</phone>
        <email>Hassan_ao@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Wajmah Sayed Karim Al Sayed</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>botox injection</keyword>
    <keyword>dry needle</keyword>
    <keyword>myofascial trigger point pain</keyword>
    <keyword>acupuncture</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Temporomandibular Joint Disorders</mesh_term>
      <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>All the study data will be available upon publication after completion of the study</ipd_description>
    </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/NCT06013644
  org study id: 17223
  nct id: NCT06013644
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox
        injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6
        months after the intervention
  All the patients will be selected and examine from the outpatient clinic of Oral and
        Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.
  
        Electromyography examination will be conducted in the department of neurophysiology
        department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged
        from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and
        symptoms of pain or muscles spams and examination shows trigger points in masticatory
        muscles. selected patients must have not received any other form of surgical treatment
        related to TMJ disorders All patients involved in this study will be divided into three
        groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry
        needle, and Botox injection.
  
        for both, acupuncture group and dry needling group, patients should receive a session/week
        for 4-6 weeks
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: change of electrical activity of mastication muscles from the baseline measurement
  time frame: 2 months after treatment
  description: change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
  measure: change of electrical activity of mastication muscles from the baseline measurement
  time frame: 6 months after treatment
  description: change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
  measure: change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
  time frame: 2 months after treatment
  description: change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
  measure: change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
  time frame: 6 months after treatment
  description: change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
  measure: Patient Satisfaction questionnaire
  time frame: 2 months after treatment
  description: Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction
  measure: Patient Satisfaction questionnaire
  time frame: 6 months after treatment
  description: Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction
  arm group label: Acupuncture needle (study group A)
  arm group type: Active Comparator
  description: a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2
  arm group label: Dry needle (study group B)
  arm group type: Active Comparator
  description: a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes
  arm group label: Botox injection (study group C)
  arm group type: Active Comparator
  description: each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
  intervention type: Device
  intervention name: Acupuncture needle
  description: a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2
  arm group label: Acupuncture needle (study group A)
  intervention type: Device
  intervention name: Dry needle
  description: a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes
  arm group label: Dry needle (study group B)
  intervention type: Drug
  intervention name: Botox Injectable Product
  description: each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
  arm group label: Botox injection (study group C)
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Wajmah Sayed Karim Al Sayed
  investigator title: Principal investigator
  mesh term: Myofascial Pain Syndromes
  mesh term: Fibromyalgia
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Syndrome
  sharing ipd: Undecided
  ipd description: All the study data will be available upon publication after completion of the study