<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/NCT04417101</url>
  </required_header>
  <id_info>
    <org_study_id>202000477A3</org_study_id>
    <nct_id>NCT04417101</nct_id>
  </id_info>
  <brief_title>Chinese Herbal Medicine for Dialysis-related Myofascial Pain: Study Protocol for A Pilot Randomized Study</brief_title>
  <official_title>A Prospective Randomized Crossover Trial to Explore the Tolerability, Safety and Effectiveness of Chinese Herbal Medicine Among Patients With Dialysis-related Myofascial Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is&#xD;
      associated with many other psychosomatic problems. Effective interventions are required to&#xD;
      alleviate pain problems in this group. Chinese herbal medicine (CHM) has been tried as a&#xD;
      potential therapeutic method to improve pain. The aim of this study is to evaluate the effect&#xD;
      of a CHM formula intervention on pain intensity, daily function, and quality of life, and&#xD;
      safety among HD patients in dialysis center within a southern Taiwan context.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life during dialysis</measure>
    <time_frame>1 year</time_frame>
    <description>Kidney Disease Quality of Life 36-Item Short-Form Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor function of upper limb</measure>
    <time_frame>1 year</time_frame>
    <description>Fugl-Meyer Assessment for upper extremity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle power</measure>
    <time_frame>1 year</time_frame>
    <description>Gripping algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score during dialysis</measure>
    <time_frame>1 year</time_frame>
    <description>Visual Analogue Scale (0-100)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>JBT treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will be instructed to take their Chinese herbal medicine formula (CHM), which named Juan Bi Tang, and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese Herb</intervention_name>
    <description>The participants will be instructed to take their JBT and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.</description>
    <arm_group_label>JBT treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (aged ≥ 20 y) undergoing conventional HD three times a week via an AV fistula;&#xD;
&#xD;
          -  To have myofascial trigger points (MTrPs) in one or more of the following muscles&#xD;
             around the AV fistula: the flexor carpi radialis, palmaris longus, the pronator teres,&#xD;
             the palmaris longus, and/or the finger flexor, diagnosed by dialysis-related&#xD;
             myofascial pain, which must be experiencing pain during HD [M1];&#xD;
&#xD;
          -  Onset of symptoms within 1 month before enrollment;&#xD;
&#xD;
          -  Capable of giving adequate response to pain;&#xD;
&#xD;
          -  Have an exquisite tenderness was found on palpation in the taut band with moderate&#xD;
             intensity of pain at baseline (ie, a pain score &gt; 3 on a numeric rating scale);&#xD;
&#xD;
          -  Can commit to not change their medication and dialytic method during the 10 weeks of&#xD;
             this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe chronic or acute disease interfering with attendance for therapy;&#xD;
&#xD;
          -  Have comorbid conditions such as rheumatoid arthritis, stroke, tumor, coagulopathy,&#xD;
             chronic liver disease, radiculopathies of the upper limb, recent history of&#xD;
             cervical/shoulder/arm surgery, or trauma;&#xD;
&#xD;
          -  Have depression and/or presence of a psychiatric disorder;&#xD;
&#xD;
          -  Have taken painkillers, muscle relaxant, and anti-inflammatory medications or used&#xD;
             topical anesthetics in the past week;&#xD;
&#xD;
          -  Have allergy to Chinese herbal product;&#xD;
&#xD;
          -  Unable to understand or sign an informed consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Yen C Tsai</last_name>
    <role>Principal Investigator</role>
    <affiliation>長庚紀念醫院</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Yen C Tsai</last_name>
    <phone>+886975056534</phone>
    <email>missuriae@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hwee-Yeong C Ng</last_name>
    <phone>+886975056085</phone>
    <email>kujiben@gmail.com</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </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/NCT04417101
org study id: 202000477A3
nct id: NCT04417101
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is
      associated with many other psychosomatic problems. Effective interventions are required to
      alleviate pain problems in this group. Chinese herbal medicine (CHM) has been tried as a
      potential therapeutic method to improve pain. The aim of this study is to evaluate the effect
      of a CHM formula intervention on pain intensity, daily function, and quality of life, and
      safety among HD patients in dialysis center within a southern Taiwan context.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life during dialysis
time frame: 1 year
description: Kidney Disease Quality of Life 36-Item Short-Form Survey
measure: Motor function of upper limb
time frame: 1 year
description: Fugl-Meyer Assessment for upper extremity
measure: Muscle power
time frame: 1 year
description: Gripping algometer
measure: Pain score during dialysis
time frame: 1 year
description: Visual Analogue Scale (0-100)
arm group label: JBT treatment
arm group type: Experimental
description: The participants will be instructed to take their Chinese herbal medicine formula (CHM), which named Juan Bi Tang, and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.
arm group label: No treatment
arm group type: No Intervention
description: Participants in the non-treatment period will receive conventional self-care management for myofascial pain syndrome.
intervention type: Drug
intervention name: Chinese Herb
description: The participants will be instructed to take their JBT and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.
arm group label: JBT treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ming-Yen C Tsai
role: Principal Investigator
affiliation: 長庚紀念醫院
last name: Ming-Yen C Tsai
phone: +886975056534
email: missuriae@yahoo.com.tw
last name: Hwee-Yeong C Ng
phone: +886975056085
email: kujiben@gmail.com
responsible party type: Sponsor
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
sharing ipd: No