<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/NCT04412733</url>
  </required_header>
  <id_info>
    <org_study_id>meryemkaysin</org_study_id>
    <nct_id>NCT04412733</nct_id>
  </id_info>
  <brief_title>EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY</brief_title>
  <official_title>EFFECTIVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENT WITH BELL'S PALSY, A DOUBLE-BLIND, RANDOMİZED, PLACEBO-CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatih Sultan Mehmet Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial&#xD;
      nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly&#xD;
      used physical modalities for treating musculoskeletal disorders. The effects of US are due to&#xD;
      alteration of cell membrane activity, vascular wall permeability and facilitation of tissue&#xD;
      healing. The aim of this study is to investigate the effect of pulsed US treatment in&#xD;
      patients with Bell's palsy when added to superficial heating, massage and exercise therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years)&#xD;
      diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients&#xD;
      were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after&#xD;
      the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and&#xD;
      orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological&#xD;
      examinations were performed by an experienced electromyographer who was blind to the&#xD;
      patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound&#xD;
      therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program&#xD;
      (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week.&#xD;
      In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2,&#xD;
      duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2&#xD;
      received exactly the same procedure as the treatment group, except that the power switch was&#xD;
      off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US&#xD;
      device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at&#xD;
      baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading&#xD;
      System, House Brackmann Facial Grading System and Facial Disability Index and&#xD;
      electrophysiologic parameters were used for outcome evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sunnybrook Facial Grading System</measure>
    <time_frame>3 months</time_frame>
    <description>Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hause Brackman Facial Nerve Grading System</measure>
    <time_frame>3 months</time_frame>
    <description>Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Facial Disability Index</measure>
    <time_frame>3 months</time_frame>
    <description>Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrophysiologic Changes</measure>
    <time_frame>3 months</time_frame>
    <description>Secondary outcome measures were changes of facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Bell Palsy</condition>
  <arm_group>
    <arm_group_label>Pulsed Ultrasound Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control group received sham ultrasound with the same protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapeutic Pulsed Ultrasound</intervention_name>
    <description>Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.</description>
    <arm_group_label>Pulsed Ultrasound Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Ultrasound</intervention_name>
    <description>Control group received sham ultrasound treatment</description>
    <arm_group_label>Sham Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-65 years&#xD;
&#xD;
          -  Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Central nervous system pathology&#xD;
&#xD;
          -  Recurrent Bell's palsy&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Contraindications of ultrasound treatment&#xD;
&#xD;
               -  Active infection&#xD;
&#xD;
               -  Cancer&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Lactation&#xD;
&#xD;
               -  Open wound around application area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meryem Yilmaz Kaysin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fatih Sultan Mehmet Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fatih Sultan Mehmet Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Ataşehir</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bell's palsy</keyword>
  <keyword>facial paralysis</keyword>
  <keyword>pulsed ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04412733
org study id: meryemkaysin
nct id: NCT04412733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial
      nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly
      used physical modalities for treating musculoskeletal disorders. The effects of US are due to
      alteration of cell membrane activity, vascular wall permeability and facilitation of tissue
      healing. The aim of this study is to investigate the effect of pulsed US treatment in
      patients with Bell's palsy when added to superficial heating, massage and exercise therapies.
In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years)
      diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients
      were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after
      the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and
      orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological
      examinations were performed by an experienced electromyographer who was blind to the
      patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound
      therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program
      (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week.
      In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2,
      duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2
      received exactly the same procedure as the treatment group, except that the power switch was
      off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US
      device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at
      baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading
      System, House Brackmann Facial Grading System and Facial Disability Index and
      electrophysiologic parameters were used for outcome evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Sunnybrook Facial Grading System
time frame: 3 months
description: Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.
measure: Hause Brackman Facial Nerve Grading System
time frame: 3 months
description: Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.
measure: Facial Disability Index
time frame: 3 months
description: Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.
measure: Electrophysiologic Changes
time frame: 3 months
description: Secondary outcome measures were changes of facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles.
arm group label: Pulsed Ultrasound Group
arm group type: Experimental
description: Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions.
arm group label: Sham Group
arm group type: Sham Comparator
description: Control group received sham ultrasound with the same protocol.
intervention type: Device
intervention name: Therapeutic Pulsed Ultrasound
description: Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.
arm group label: Pulsed Ultrasound Group
intervention type: Device
intervention name: Sham Ultrasound
description: Control group received sham ultrasound treatment
arm group label: Sham Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Meryem Yilmaz Kaysin, MD
role: Principal Investigator
affiliation: Fatih Sultan Mehmet Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Bell Palsy
mesh term: Facial Paralysis
mesh term: Paralysis
sharing ipd: No
ipd description: Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.