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/NCT05972837</url>
    </required_header>
    <id_info>
      <org_study_id>N202204099</org_study_id>
      <nct_id>NCT05972837</nct_id>
    </id_info>
    <brief_title>Effects of Home-based Surface Electrical Stimulation for Patients With Cervical Myofascial Pain Syndrome</brief_title>
    <official_title>Effects of Home-based Surface Electrical Stimulation for Patients With Cervical Myofascial Pain Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Medical University WanFang Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Medical University WanFang Hospital</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 study is to compare the developed home-based surface electrical stimulation&#xD;
        program to the controls in computer office workers with MPS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cervical myofascial pain syndrome (MPS) is a common problem among workers who have large&#xD;
        amount of computer use. Additionally, owing to the high workload and long hours of staying in&#xD;
        thier cubicle, the office employees are often unable to have extra time to receive&#xD;
        rehabilitation and treatment regularly. A home-based surface electrical stimulation (SES)&#xD;
        program is developed to help intervention be time-saving and more accessible for office-based&#xD;
        staff busy at work.&#xD;
  &#xD;
        In this single-blind randomized controlled trial, participants will be assigned to one of the&#xD;
        following three groups and undergo 3 weeks (20 minutes/ time, three times/ week) of&#xD;
        intervention:&#xD;
  &#xD;
          1. SES combined with telemedical support&#xD;
  &#xD;
          2. SES&#xD;
  &#xD;
          3. No intervention&#xD;
  &#xD;
        The outcome assessments will be performed before and after the intervention (0-wk and 4-wk)&#xD;
        and 4 weeks after the endpoint of intervention (8-wk). The outcome assessor was blind to the&#xD;
        intervention and group allocation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>4 weeks</time_frame>
      <description>A visual analog scale (VAS, scoring from 0-10) is used to measure a participant's pain intensity. The participant indicates their level of pain on average over the past 3 days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>8 weeks</time_frame>
      <description>A visual analog scale (VAS, scoring from 0-10) is used to measure a participant's pain intensity. The participant indicates their level of pain on average and at its worst during work or at rest over the past 3 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion of the neck</measure>
      <time_frame>8 weeks</time_frame>
      <description>The range of motion of the neck is measured by using motion capture system with the IMU (inertial measurement unit) sensors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain pressure threshold (kg/m2)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The pain pressure threshold is measured by using a hand-held dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neck disability index (NDI, 0~100%)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The NDI is a questionnaire used for assessing self-rated disability in patient participant with neck pain of mechanical origin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Anxiety Inventory (BAI, scoring from 0~63)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The BAI is a brief, self-report assessment for measuring anxiety severity and level.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Myofascial Pain Syndrome of Neck</condition>
    <arm_group>
      <arm_group_label>SES combined with telemedical support</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SES device for personal use will be provided for participants in addition to remote medical support.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SES</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will also attend an appointment via a video call with a rehabilitation doctor in the first week but no weekly telehealth visits. Only SES device for personal use and a user manual will be provided.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group will not be provided either SES device or weekly telehealth visits. They are only required to attend a session of video call with a rehabilitation doctor in the first week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Surface electrical stimulation (SES)</intervention_name>
      <description>Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.</description>
      <arm_group_label>SES</arm_group_label>
      <arm_group_label>SES combined with telemedical support</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Remote medical support</intervention_name>
      <description>The remote medical support includes a session of video call with a rehabilitation doctor in the first week and weekly telehealth visits with a live physical therapist or physician. The contents of the video calls contain patient education, stretching exercises teaching and instructions of using SES for MPS.</description>
      <arm_group_label>SES combined with telemedical support</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Time of using computer &gt; 4hrs/day&#xD;
  &#xD;
            -  Neck pain &gt; 2 months&#xD;
  &#xD;
            -  Diagnosis of cervical myofascial pain syndrome&#xD;
  &#xD;
            -  VAS pain ≥ 3 (0~10)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Had a history of neck surgery&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Systematic disease (e.g. autoimmune disorders, arthritis, infection, etc.)&#xD;
  &#xD;
            -  Malignancy&#xD;
  &#xD;
            -  Neurological signs such as radiating pain, motor weakness in the upper extremities.&#xD;
  &#xD;
            -  Skin defect or scars at the planned placement of SES&#xD;
  &#xD;
            -  Pacemaker user&#xD;
  &#xD;
            -  History of seizure attack&#xD;
  &#xD;
            -  History of diabetes&#xD;
  &#xD;
            -  Fear of receiving SES&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>WanFang Hospital</name>
        <address>
          <city>New Taipei City</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yen-Nung Lin, MD, MS</last_name>
        <phone>+886970746879</phone>
        <email>semitune@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
      <investigator_full_name>Yen-Nung Lin</investigator_full_name>
      <investigator_title>Director of Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Myofascial Pain Syndromes</keyword>
    <keyword>Surface electrical stimulation</keyword>
    <keyword>Remote medical support</keyword>
    <keyword>Telemedicine</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>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</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/NCT05972837
  org study id: N202204099
  nct id: NCT05972837
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare the developed home-based surface electrical stimulation
        program to the controls in computer office workers with MPS.
  Cervical myofascial pain syndrome (MPS) is a common problem among workers who have large
        amount of computer use. Additionally, owing to the high workload and long hours of staying in
        thier cubicle, the office employees are often unable to have extra time to receive
        rehabilitation and treatment regularly. A home-based surface electrical stimulation (SES)
        program is developed to help intervention be time-saving and more accessible for office-based
        staff busy at work.
  
        In this single-blind randomized controlled trial, participants will be assigned to one of the
        following three groups and undergo 3 weeks (20 minutes/ time, three times/ week) of
        intervention:
  
          1. SES combined with telemedical support
  
          2. SES
  
          3. No intervention
  
        The outcome assessments will be performed before and after the intervention (0-wk and 4-wk)
        and 4 weeks after the endpoint of intervention (8-wk). The outcome assessor was blind to the
        intervention and group allocation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pain intensity
  time frame: 4 weeks
  description: A visual analog scale (VAS, scoring from 0-10) is used to measure a participant's pain intensity. The participant indicates their level of pain on average over the past 3 days.
  measure: Pain intensity
  time frame: 8 weeks
  description: A visual analog scale (VAS, scoring from 0-10) is used to measure a participant's pain intensity. The participant indicates their level of pain on average and at its worst during work or at rest over the past 3 days.
  measure: Range of motion of the neck
  time frame: 8 weeks
  description: The range of motion of the neck is measured by using motion capture system with the IMU (inertial measurement unit) sensors.
  measure: Pain pressure threshold (kg/m2)
  time frame: 8 weeks
  description: The pain pressure threshold is measured by using a hand-held dynamometer.
  measure: Neck disability index (NDI, 0~100%)
  time frame: 8 weeks
  description: The NDI is a questionnaire used for assessing self-rated disability in patient participant with neck pain of mechanical origin.
  measure: Beck Anxiety Inventory (BAI, scoring from 0~63)
  time frame: 8 weeks
  description: The BAI is a brief, self-report assessment for measuring anxiety severity and level.
  arm group label: SES combined with telemedical support
  arm group type: Experimental
  description: SES device for personal use will be provided for participants in addition to remote medical support.
  arm group label: SES
  arm group type: Active Comparator
  description: Participants in this group will also attend an appointment via a video call with a rehabilitation doctor in the first week but no weekly telehealth visits. Only SES device for personal use and a user manual will be provided.
  arm group label: No intervention
  arm group type: No Intervention
  description: Participants in this group will not be provided either SES device or weekly telehealth visits. They are only required to attend a session of video call with a rehabilitation doctor in the first week.
  intervention type: Device
  intervention name: Surface electrical stimulation (SES)
  description: Participants will undergo 3 weeks (20 minutes/ time, three times/ week) of SES intervention.
  arm group label: SES
  arm group label: SES combined with telemedical support
  intervention type: Other
  intervention name: Remote medical support
  description: The remote medical support includes a session of video call with a rehabilitation doctor in the first week and weekly telehealth visits with a live physical therapist or physician. The contents of the video calls contain patient education, stretching exercises teaching and instructions of using SES for MPS.
  arm group label: SES combined with telemedical support
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Taipei Medical University WanFang Hospital
  investigator full name: Yen-Nung Lin
  investigator title: Director of Physical Medicine and Rehabilitation
  mesh term: Myofascial Pain Syndromes
  mesh term: Fibromyalgia
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: No