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/NCT06001112</url>
    </required_header>
    <id_info>
      <org_study_id>2021-06-clinical study</org_study_id>
      <nct_id>NCT06001112</nct_id>
    </id_info>
    <brief_title>Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis</brief_title>
    <acronym>CAAGA</acronym>
    <official_title>Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</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 goal of this clinical trial is to evaluate the immediate analgesic effect and patients'&#xD;
        evaluation of the treatment of cheek acupuncture in patients with acute gouty arthritis. The&#xD;
        main question it aims to answer are: Does cheek acupuncture has immediate pain relief effects&#xD;
        on patients with acute gouty arthritis. Participants will received cheek acupuncture for 30&#xD;
        mins.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare etoricoxib group to see if cheek&#xD;
        acupuncture is superior to etoricoxib for improvement of acute pain in subjects with acute&#xD;
        gouty arthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The symptoms of acute gouty arthritis (AGA) are extremely painful, but most patients do not&#xD;
        begin to experience pain relief until after they have been seen by a doctor and have taken&#xD;
        their medication, leaving a time lag between the time they are seen and the time the&#xD;
        treatment is effective. In clinical practice, researchers have found that the use of cheek&#xD;
        acupuncture at the first visit to the patient often provides some immediate pain relief, but&#xD;
        there is no evidence-based evidence for this.&#xD;
  &#xD;
        This project was designed as a prospective, randomized, controlled clinical trial, in which&#xD;
        patients with AGA who were seen for the first time were studied, and the treatment group was&#xD;
        given cheek acupuncture and the control group was given oral etoricoxib tablets. VAS will be&#xD;
        recorded before treatment, 0 min, 30 min, 1 h and 2 h after the start of treatment to depict&#xD;
        the immediate analgesic efficacy curve and compare the immediate analgesic effect of the two&#xD;
        groups at different time points. If the project is successfully completed, it will explore a&#xD;
        treatment method for acute gouty arthritis that is fast-acting, painless and effective,&#xD;
        eliminating the time lag between consultation and efficacy for the benefit of gout patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scoring (VAS)</measure>
      <time_frame>baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment</time_frame>
      <description>a 10 cm long horizontal or vertical line that divides the pain level into 10 levels (i.e., 1 level for every 1 cm), with the leftmost (or upper) end representing &quot;no pain&quot; and the rightmost (or lower) end representing &quot;severe pain The leftmost (or upper) end represents &quot;no pain&quot; and the rightmost (or lower) end represents &quot;severe pain&quot;, and the patient is asked to mark the pain level he/she feels with an &quot;I&quot; on this line.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient feedback score</measure>
      <time_frame>2 hours after the start of treatment</time_frame>
      <description>an 8-point patient global assessent of treatment response score was used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immediate pain relief</measure>
      <time_frame>2 hours after the start of treatment</time_frame>
      <description>After the efficacy evaluation of the pain index by retesting 2 hours after the first treatment, the degree of pain relief was divided into: immediate efficacy, which means that all the pain was relieved; apparent efficacy, which means that the pain symptoms were significantly relieved; improvement, which means that the pain situation was relieved; and ineffectiveness, which means that the pain was not resolved at all. Immediate apparent efficiency = immediate efficiency + apparent efficiency.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Acute Gout Arthritis</condition>
    <condition>Acupuncture</condition>
    <condition>Acute Pain</condition>
    <arm_group>
      <arm_group_label>acupuncture group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subjects will received cheek acupuncture for one time</description>
    </arm_group>
    <arm_group>
      <arm_group_label>etoricoxib</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>subjects will received etoricoxib 120mg for one time</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>cheek acupuncture</intervention_name>
      <description>Based on the theory of holography and the theory of the Great Sanjiao, the acupoints were chosen under the guidance of the foundation of cheek acupuncture, selecting bilateral Sanjiao acupoints, bilateral head acupoints, foot and ankle acupoints on the affected side, and matching acupuncture points for local strengthening of the foot and ankle acupuncture points, using the triangular needle strengthening method. The treatment was performed with the patient lying on his back in a comfortable position, with routine local disinfection, rapid transdermal needle entry to the acupuncture points, and needle discharge after 30 minutes of needle retention, after which the needle hole was compressed with a cotton ball for a few moments.</description>
      <arm_group_label>acupuncture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Etoricoxib</intervention_name>
      <description>etoricoxib 120mg</description>
      <arm_group_label>etoricoxib</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet the diagnostic criteria for acute gouty arthritis and with attacks in the&#xD;
               unilateral ankle or first metatarsophalangeal joint;&#xD;
  &#xD;
                 -  Age ≥18 years old and ≤75 years old, regardless of gender; ③ The gouty arthritis&#xD;
                    attack is within 48h; ④ Without therapy with targeted topical treatment or&#xD;
                    self-administered medications including colchicine, anti-inflammatory pain&#xD;
                    medications, hormones, herbs, etc.&#xD;
  &#xD;
          Agreement to comply with the clinician's treatment plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breast-feeding&#xD;
  &#xD;
                 -  Patients with malignant tumors, severe dysfunction of the heart, liver, and&#xD;
                    kidneys, diabetes mellitus and hypertension&#xD;
  &#xD;
                      -  Mental disorders that render the patient unable to understand the nature of&#xD;
                         the study, its scope, and possible outcomes or unable to follow the doctor's&#xD;
                         advice&#xD;
  &#xD;
                           -  Allergic to the components of the drug in this study&#xD;
  &#xD;
                                -  Patients with active peptic ulcers/bleeding, or previous recurrent&#xD;
                                   ulcers/bleeding.&#xD;
  &#xD;
                                     -  History of asthma, urticaria or allergic reactions induced by&#xD;
                                        taking aspirin or other non-steroidal anti-inflammatory drugs&#xD;
  &#xD;
                                          -  Congestive heart failure (New York Heart Association&#xD;
                                             [NYHA] cardiac function class II-IV)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yuping Lin, P.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuping Lin, P.D.</last_name>
      <phone>+86 13570459624</phone>
      <email>yupinglin@gzucm.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>Yuping Lin</investigator_full_name>
      <investigator_title>P.D.</investigator_title>
    </responsible_party>
    <keyword>Acute Gout Arthritis</keyword>
    <keyword>acupuncture</keyword>
    <keyword>Acute pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Gouty</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Etoricoxib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>request from the author</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>3year after the end of the trial</ipd_time_frame>
    </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/NCT06001112
  org study id: 2021-06-clinical study
  nct id: NCT06001112
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the immediate analgesic effect and patients'
        evaluation of the treatment of cheek acupuncture in patients with acute gouty arthritis. The
        main question it aims to answer are: Does cheek acupuncture has immediate pain relief effects
        on patients with acute gouty arthritis. Participants will received cheek acupuncture for 30
        mins.
  
        If there is a comparison group: Researchers will compare etoricoxib group to see if cheek
        acupuncture is superior to etoricoxib for improvement of acute pain in subjects with acute
        gouty arthritis.
  The symptoms of acute gouty arthritis (AGA) are extremely painful, but most patients do not
        begin to experience pain relief until after they have been seen by a doctor and have taken
        their medication, leaving a time lag between the time they are seen and the time the
        treatment is effective. In clinical practice, researchers have found that the use of cheek
        acupuncture at the first visit to the patient often provides some immediate pain relief, but
        there is no evidence-based evidence for this.
  
        This project was designed as a prospective, randomized, controlled clinical trial, in which
        patients with AGA who were seen for the first time were studied, and the treatment group was
        given cheek acupuncture and the control group was given oral etoricoxib tablets. VAS will be
        recorded before treatment, 0 min, 30 min, 1 h and 2 h after the start of treatment to depict
        the immediate analgesic efficacy curve and compare the immediate analgesic effect of the two
        groups at different time points. If the project is successfully completed, it will explore a
        treatment method for acute gouty arthritis that is fast-acting, painless and effective,
        eliminating the time lag between consultation and efficacy for the benefit of gout patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Visual Analogue Scoring (VAS)
  time frame: baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment
  description: a 10 cm long horizontal or vertical line that divides the pain level into 10 levels (i.e., 1 level for every 1 cm), with the leftmost (or upper) end representing "no pain" and the rightmost (or lower) end representing "severe pain The leftmost (or upper) end represents "no pain" and the rightmost (or lower) end represents "severe pain", and the patient is asked to mark the pain level he/she feels with an "I" on this line.
  measure: Patient feedback score
  time frame: 2 hours after the start of treatment
  description: an 8-point patient global assessent of treatment response score was used
  measure: Immediate pain relief
  time frame: 2 hours after the start of treatment
  description: After the efficacy evaluation of the pain index by retesting 2 hours after the first treatment, the degree of pain relief was divided into: immediate efficacy, which means that all the pain was relieved; apparent efficacy, which means that the pain symptoms were significantly relieved; improvement, which means that the pain situation was relieved; and ineffectiveness, which means that the pain was not resolved at all. Immediate apparent efficiency = immediate efficiency + apparent efficiency.
  arm group label: acupuncture group
  arm group type: Experimental
  description: subjects will received cheek acupuncture for one time
  arm group label: etoricoxib
  arm group type: Active Comparator
  description: subjects will received etoricoxib 120mg for one time
  intervention type: Other
  intervention name: cheek acupuncture
  description: Based on the theory of holography and the theory of the Great Sanjiao, the acupoints were chosen under the guidance of the foundation of cheek acupuncture, selecting bilateral Sanjiao acupoints, bilateral head acupoints, foot and ankle acupoints on the affected side, and matching acupuncture points for local strengthening of the foot and ankle acupuncture points, using the triangular needle strengthening method. The treatment was performed with the patient lying on his back in a comfortable position, with routine local disinfection, rapid transdermal needle entry to the acupuncture points, and needle discharge after 30 minutes of needle retention, after which the needle hole was compressed with a cotton ball for a few moments.
  arm group label: acupuncture group
  intervention type: Drug
  intervention name: Etoricoxib
  description: etoricoxib 120mg
  arm group label: etoricoxib
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yuping Lin, P.D.
  role: Principal Investigator
  affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
  last name: Yuping Lin, P.D.
  phone: +86 13570459624
  email: yupinglin@gzucm.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
  investigator full name: Yuping Lin
  investigator title: P.D.
  mesh term: Arthritis
  mesh term: Arthritis, Gouty
  mesh term: Acute Pain
  mesh term: Etoricoxib
  sharing ipd: Yes
  ipd description: request from the author
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: 3year after the end of the trial