<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/NCT04429126</url>
  </required_header>
  <id_info>
    <org_study_id>109059-E</org_study_id>
    <nct_id>NCT04429126</nct_id>
  </id_info>
  <brief_title>Acupressure in Reducing Post-TBI Fatigue</brief_title>
  <official_title>The Effect of Acupressure on Relieving Fatigue Following Traumatic Brain Injury: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior&#xD;
      works have demonstrated that it may profoundly impact the ability to return to productive&#xD;
      activity and cognitive functions. However, few interventions have been applied in this&#xD;
      population.The purpose of the current will be to test the effect of acupressure on fatigue&#xD;
      reduction after traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fatigue is a pervasive and critical long-lasting symptom experienced by patients with&#xD;
      traumatic brain injury (TBI) and can persist up to months or years after head injury.&#xD;
      However, thus far, only few non-pharmacological interventions, such as mindfulness, are&#xD;
      implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure&#xD;
      can significantly improve fatigue in different populations, such as cancers survivors and&#xD;
      patients with hemodialysis. Therefore, we would like to test whether acupressure effectively&#xD;
      improve fatigue after TBI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 18, 2021</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>Fatigue</measure>
    <time_frame>4 weeks</time_frame>
    <description>Self-reported feeling of tiredness, is measured by the Chinese version of The Mental fatigue Scale (MFS, higher scores indicate greater mental fatigue) and Multidimensional Fatigue Inventory (MFI, higher score indicates more fatigue)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Memory function</measure>
    <time_frame>4 weeks</time_frame>
    <description>The function will be measured by using the Rey Auditory Verbal Learning Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention function</measure>
    <time_frame>4 weeks</time_frame>
    <description>The function will be measured by using the Trail Making Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>My ECG E3-8010</time_frame>
    <description>We will measure HRV parameter using the device of My ECG E3-8010</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain waves</measure>
    <time_frame>4 weeks</time_frame>
    <description>measured by the NeuroSky MindWave Mobile 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>4 weeks</time_frame>
    <description>Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>4-point acupressure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 5-point acupressure group will be instructed on the following acupressure points: sanyinjiao (SP6), Zu San Li (ST36), shenmen (TF4), Yongquan (KI-1), and He Gu (LI4).&#xD;
Bilateral 1.5 min for each point, three times daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 -point acupressure group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 2-point acupressure group will be instructed on the following acupressure points: He Gu (LI4) and Tai Chong (LV3).&#xD;
Bilateral 1.5 min for each point, three times daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acupressure</intervention_name>
    <description>Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.</description>
    <arm_group_label>4 -point acupressure group</arm_group_label>
    <arm_group_label>4-point acupressure group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS)&#xD;
             from 3-12.&#xD;
&#xD;
          -  Aged between 20-65 years&#xD;
&#xD;
          -  Are able to communicate in Chinese and Mandarin&#xD;
&#xD;
          -  Are able to complete the questionnaires&#xD;
&#xD;
          -  Complain of tiredness and cannot be restored even after a rest.&#xD;
&#xD;
          -  No physical disability and visual impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With skin lesion&#xD;
&#xD;
          -  had diagnosis of neuropathy and paraesthesia prior to study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsiao-Yean Chiu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hsiao-Yean Chiu</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 30, 2022</last_update_submitted>
  <last_update_submitted_qc>January 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Hsiao-Yean Chiu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04429126
org study id: 109059-E
nct id: NCT04429126
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior
      works have demonstrated that it may profoundly impact the ability to return to productive
      activity and cognitive functions. However, few interventions have been applied in this
      population.The purpose of the current will be to test the effect of acupressure on fatigue
      reduction after traumatic brain injury.
Fatigue is a pervasive and critical long-lasting symptom experienced by patients with
      traumatic brain injury (TBI) and can persist up to months or years after head injury.
      However, thus far, only few non-pharmacological interventions, such as mindfulness, are
      implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure
      can significantly improve fatigue in different populations, such as cancers survivors and
      patients with hemodialysis. Therefore, we would like to test whether acupressure effectively
      improve fatigue after TBI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fatigue
time frame: 4 weeks
description: Self-reported feeling of tiredness, is measured by the Chinese version of The Mental fatigue Scale (MFS, higher scores indicate greater mental fatigue) and Multidimensional Fatigue Inventory (MFI, higher score indicates more fatigue)
measure: Memory function
time frame: 4 weeks
description: The function will be measured by using the Rey Auditory Verbal Learning Test
measure: Attention function
time frame: 4 weeks
description: The function will be measured by using the Trail Making Test
measure: Heart rate variability
time frame: My ECG E3-8010
description: We will measure HRV parameter using the device of My ECG E3-8010
measure: Brain waves
time frame: 4 weeks
description: measured by the NeuroSky MindWave Mobile 2
measure: Sleep quality
time frame: 4 weeks
description: Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index
arm group label: 4-point acupressure group
arm group type: Experimental
description: The 5-point acupressure group will be instructed on the following acupressure points: sanyinjiao (SP6), Zu San Li (ST36), shenmen (TF4), Yongquan (KI-1), and He Gu (LI4).
Bilateral 1.5 min for each point, three times daily for 4 weeks.
arm group label: 4 -point acupressure group
arm group type: Active Comparator
description: The 2-point acupressure group will be instructed on the following acupressure points: He Gu (LI4) and Tai Chong (LV3).
Bilateral 1.5 min for each point, three times daily for 4 weeks.
arm group label: Usual care
arm group type: No Intervention
description: The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.
intervention type: Behavioral
intervention name: Acupressure
description: Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
arm group label: 4 -point acupressure group
arm group label: 4-point acupressure group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hsiao-Yean Chiu, PhD
role: Principal Investigator
affiliation: School of Nursing, Taipei Medical University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Hsiao-Yean Chiu
investigator title: Associate Professor
mesh term: Fatigue
sharing ipd: No