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/NCT05987683</url>
    </required_header>
    <id_info>
      <org_study_id>23060907</org_study_id>
      <nct_id>NCT05987683</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle</brief_title>
    <official_title>The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia 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>
        Myofascial pain is characterized by myofascial trigger points, considered as a major cause of&#xD;
        neck and shoulder pain in the working population. Thread-embedding acupuncture is a new&#xD;
        acupuncture modality that can provide long-term stimulation aimed at prolonging its&#xD;
        therapeutic effect that is similar to conventional acupuncture, such as analgesic effects.&#xD;
        The goal of this randomized controlled trial is to evaluate and compare the effects of&#xD;
        thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for&#xD;
        myofascial pain in the upper trapezius muscle. The primary aim of this study is to&#xD;
        investigate whether thread-embedding acupuncture therapy gives better and last longer results&#xD;
        for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a clinical trial study to evaluate and compare the effects of thread-embedding&#xD;
        acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the&#xD;
        upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper&#xD;
        trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture&#xD;
        and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The&#xD;
        outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks&#xD;
        after treatment. Patients and the outcome assessors will be blinded to the group allocation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Visual Analog Scale</measure>
      <time_frame>before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment</time_frame>
      <description>Pain rating scale for measuring pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neck Disability Index</measure>
      <time_frame>before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment</time_frame>
      <description>A questionnaire for measuring self-rated disability due to neck pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure Pain Threshold</measure>
      <time_frame>before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment</time_frame>
      <description>Using the minimum force applied which induces pain, measured with algometer</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Myofascial Pain of Upper Trapezius Muscle</condition>
    <arm_group>
      <arm_group_label>Thread-Embedding Acupuncture</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Thread-Embedding Acupuncture</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture</intervention_name>
      <description>Thread-Embedding Acupuncture: using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Sham Thread-Embedding Acupuncture: using a 29-gauge TEA needle but thread-removed, just needle alone</description>
      <arm_group_label>Sham Thread-Embedding Acupuncture</arm_group_label>
      <arm_group_label>Thread-Embedding Acupuncture</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female aged 18-59 years.&#xD;
  &#xD;
            -  Subject with myofascial pain in the upper trapezius muscle.&#xD;
  &#xD;
            -  VAS score of 30-70 mm from 100 mm during activities (everyday activities or light&#xD;
               exercise).&#xD;
  &#xD;
            -  Pain &gt; 3 months.&#xD;
  &#xD;
            -  Willing to participate in this research to completion and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Fibromyalgia.&#xD;
  &#xD;
            -  Have had cervical spine surgery.&#xD;
  &#xD;
            -  Have done Dry needling therapy on the upper trapezius muscle in the last 9 days&#xD;
  &#xD;
            -  Have done thread acupuncture on the upper trapezius muscle in the last 6 months.&#xD;
  &#xD;
            -  Have performed pharmacopuncture on the upper trapezius muscle in the last 6 months.&#xD;
  &#xD;
            -  VAS score is more than 70 mm than 100 mm at resting.&#xD;
  &#xD;
            -  History of anti-inflammatory drug treatment in the previous 2 weeks.&#xD;
  &#xD;
            -  History of intra-articular steroid injections in the previous 3 months.&#xD;
  &#xD;
            -  There is a tumor, wound, or skin infection at the needle insertion area.&#xD;
  &#xD;
            -  Fever (≥ 37.5 oC).&#xD;
  &#xD;
            -  There is a hypersensitivity reaction in previous acupuncture therapy (metal allergy,&#xD;
               severe atopy, keloids, or other skin hypersensitivity).&#xD;
  &#xD;
            -  Suffering from a blood disorder or taking blood thinners (anti-platelet or&#xD;
               anti-coagulant drugs).&#xD;
  &#xD;
            -  Have a heart condition or uncontrolled diabetes.&#xD;
  &#xD;
            -  Blood glucose level (GDS) ≥200 mg/dL is checked by capillary blood using a glucometer.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>KEPK FKUI-RSCM</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emilia P Winarno, Doctor</last_name>
      <phone>+628122018588</phone>
      <email>lia_pw@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cipto Mangunkusumo Hospital</name>
        <address>
          <city>Jakarta</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cipto Mangunkusumo, Hospital</last_name>
        <phone>1 500 135</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Persahabatan Hospital</name>
        <address>
          <city>Jakarta</city>
          <state>DKI Jakarta</state>
          <zip>13230</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Persahabatan, Hospital</last_name>
        <phone>(021) 4891708</phone>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Emilia Puspitasari Winarno</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT05987683
  org study id: 23060907
  nct id: NCT05987683
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Myofascial pain is characterized by myofascial trigger points, considered as a major cause of
        neck and shoulder pain in the working population. Thread-embedding acupuncture is a new
        acupuncture modality that can provide long-term stimulation aimed at prolonging its
        therapeutic effect that is similar to conventional acupuncture, such as analgesic effects.
        The goal of this randomized controlled trial is to evaluate and compare the effects of
        thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for
        myofascial pain in the upper trapezius muscle. The primary aim of this study is to
        investigate whether thread-embedding acupuncture therapy gives better and last longer results
        for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.
  This is a clinical trial study to evaluate and compare the effects of thread-embedding
        acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the
        upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper
        trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture
        and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The
        outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks
        after treatment. Patients and the outcome assessors will be blinded to the group allocation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Visual Analog Scale
  time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
  description: Pain rating scale for measuring pain
  measure: Neck Disability Index
  time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
  description: A questionnaire for measuring self-rated disability due to neck pain
  measure: Pressure Pain Threshold
  time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
  description: Using the minimum force applied which induces pain, measured with algometer
  arm group label: Thread-Embedding Acupuncture
  arm group type: Experimental
  description: Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread
  arm group label: Sham Thread-Embedding Acupuncture
  arm group type: Sham Comparator
  description: Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone
  intervention type: Procedure
  intervention name: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture
  description: Thread-Embedding Acupuncture: using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Sham Thread-Embedding Acupuncture: using a 29-gauge TEA needle but thread-removed, just needle alone
  arm group label: Sham Thread-Embedding Acupuncture
  arm group label: Thread-Embedding Acupuncture
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: No
  last name: KEPK FKUI-RSCM
  role: Principal Investigator
  affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
  last name: Emilia P Winarno, Doctor
  phone: +628122018588
  email: lia_pw@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Emilia Puspitasari Winarno
  investigator title: Doctor
  mesh term: Myofascial Pain Syndromes
  sharing ipd: Yes
  ipd info type: Study Protocol