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/NCT06001047</url>
    </required_header>
    <id_info>
      <org_study_id>ACURS</org_study_id>
      <nct_id>NCT06001047</nct_id>
    </id_info>
    <brief_title>Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV</brief_title>
    <official_title>Effect of Head Acupuncture on Residual Symptoms After Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo: a Single-center Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xi'an No.3 Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xi'an No.3 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>
        Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular&#xD;
        disorder, and currently, manual repositioning techniques are often used for treatment.&#xD;
        However, up to 30%-50% of patients may experience residual symptoms such as non-rotational&#xD;
        dizziness, heaviness, instability, and emotional disturbances even after successful&#xD;
        repositioning, which significantly impacts their daily functioning and quality of life.&#xD;
        Electroacupuncture therapy has been proven to be an effective treatment for dizziness and has&#xD;
        been applied to various vestibular disorder patients. However, the efficacy of&#xD;
        electroacupuncture on the residual effects of successfully repositioned BPPV patients remains&#xD;
        unclear. This study aims to explore the effectiveness of three regimens: electroacupuncture,&#xD;
        betahistine in patients with residual symptoms after successful manual repositioning.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research objectives:&#xD;
  &#xD;
          1. Explore the risk factors that influence residual effects after BPPV and develop a&#xD;
             predictive score chart.&#xD;
  &#xD;
          2. Determine the gait characteristics of patients with residual effects after successful&#xD;
             repositioning of BPPV.&#xD;
  &#xD;
          3. Compare the clinical efficacy of different intervention strategies for the treatment of&#xD;
             residual symptoms after successful repositioning of BPPV.&#xD;
  &#xD;
        Research subjects:&#xD;
  &#xD;
        From June 2023 to June 2024, patients aged between 18-65 who are first diagnosed with BPPV&#xD;
        will be recruited from the outpatient and inpatient departments of the Third Hospital of&#xD;
        Xi'an City, affiliated to Northwest University. For posterior canal BPPV, Epley or Semont&#xD;
        maneuver will be performed; for horizontal canal BPPV, Gufoni maneuver will be performed; for&#xD;
        anterior canal BPPV, Yacovino maneuver will be performed. The patients will be observed for&#xD;
        30 minutes after the positioning maneuver to confirm the successful repositioning. On the&#xD;
        second day after the maneuver, the follow-up personnel of the research team will contact the&#xD;
        patient by phone or online to determine whether they have residual dizziness symptoms and&#xD;
        whether they are willing to participate in the study. Those who agree can come to the&#xD;
        hospital for reassessment to confirm the successful repositioning.&#xD;
  &#xD;
        Residual symptom evaluation criteria:&#xD;
  &#xD;
        On the 2nd day after successful repositioning, ask the patient if they have persistent&#xD;
        nonspecific symptoms such as dizziness, feeling of heaviness in the head, unsteadiness, or&#xD;
        floating sensation, without positional vertigo.&#xD;
  &#xD;
        Sample size estimation:&#xD;
  &#xD;
        According to the sample size design plan of randomized controlled studies, with a Type I&#xD;
        error of α=0.05, a Type II error of 1-β=0.8, an incidence rate of P1=0.6 in the intervention&#xD;
        group, an incidence rate of P2=0.45 in the control group, and a 1:1 ratio, 50 participants&#xD;
        are allocated to each group with a total of 150 participants. Assuming a certain proportion&#xD;
        of dropouts in each group, the sample size of each group required for enrollment is 60&#xD;
        participants.&#xD;
  &#xD;
        Randomization and blinding:&#xD;
  &#xD;
        The postoperative patients were randomly divided into two groups: Group A (acupuncture group)&#xD;
        and Group B (betahistine group) using SPSS 20.0 software. This study did not apply blinding&#xD;
        to the operators or patients, while the outcome assessors and data analysts were blinded.&#xD;
  &#xD;
        Data collection: Baseline data including demographic information, medical history, physical&#xD;
        examination, laboratory tests, and vestibular function tests were collected at enrollment.&#xD;
        Dizziness Handicap Inventory (DHI) and Visual Analog Scale (VAS) scores were collected at&#xD;
        baseline, 3 days after treatment, 1 week after treatment, 2 weeks after treatment, and 4&#xD;
        weeks after treatment. In addition, balance function and gait tests were performed at each&#xD;
        time point.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2026</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 (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS) score</measure>
      <time_frame>1weeks after treatment</time_frame>
      <description>A scale used to evaluate the degree of dizziness in patients, scores range from 0 to 10, with higher scores indicating more severe degree of dizziness they feel.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dizziness Handicap Inventory</measure>
      <time_frame>1weeks after treatment</time_frame>
      <description>Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Foam posturography</measure>
      <time_frame>1weeks after treatment</time_frame>
      <description>The sponge-cushion posturing is a quantitative method for measuring postural stability. The test-retest reliability of sponge-cushion posturing is good (ICC = 0.887-0.973)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Benign Paroxysmal Positional Vertigo</condition>
    <arm_group>
      <arm_group_label>Group A (acupuncture group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B (betahistine group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment patients with residual symptoms after successful manual repositioning by oral betahistine</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Group A</intervention_name>
      <description>Acupoint selection: The location of the vertigo-auditory area follows the positioning standard of Jiao Shunfa's Head Acupuncture. Operation: Electroacupuncture stimulation in the vertigo-auditory area of affected side. Pulse electrotherapy produced by Wujin Changcheng Medical Instrument. Sparse-dense waveforms are selected, with a voltage of 2-4V, a frequency of 60-80 times/min, and the intensity is determined by the patient's tolerance. The needle is in affected side for 30 minutes, and treatment is given once daily for a total of 5 days.</description>
      <arm_group_label>Group A (acupuncture group)</arm_group_label>
      <other_name>Scalp acupuncture</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Group B</intervention_name>
      <description>The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as &quot;Minshilang&quot; in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd. The dosage is 12mg, three times a day (Tid) for four consecutive weeks. Compliance monitoring is conducted by counting the remaining tablets in the medication packaging box brought by patients during the 4-week follow-up period. Concurrent use of other medications that may affect the observation results, such as anti-anxiety drugs, vestibular suppressants, and anti-dizziness Chinese patent medicines, is considered a violation of the protocol.</description>
      <arm_group_label>Group B (betahistine group)</arm_group_label>
      <other_name>betahistine group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. According to the diagnostic criteria and therapeutic efficacy evaluation for benign&#xD;
               paroxysmal positional vertigo (BPPV) formulated by the Otolaryngology-Head and Neck&#xD;
               Surgery Branch of the Chinese Medical Association, the patient was confirmed as having&#xD;
               BPPV and the repositioning maneuver was successful.&#xD;
  &#xD;
            2. After the maneuver, the patient's clinical symptoms were relieved, with no sense of&#xD;
               rotation or dizziness, but residual symptoms such as discomfort and unsteady gait&#xD;
               persisted.&#xD;
  &#xD;
            3. There were no obvious communication barriers or visual impairments.&#xD;
  &#xD;
            4. The patient and their family members agreed to the treatment plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with other ear diseases, history of head trauma or surgery;&#xD;
  &#xD;
                 -  Patients who are weak and unable to tolerate, pregnant women;&#xD;
  &#xD;
                      -  Patients who have undergone vestibular rehabilitation training before this&#xD;
                         treatment; ④ Patients with joint diseases that affect balance and walking; ⑤&#xD;
                         Patients with a history of brain organic diseases (such as tumors, stroke,&#xD;
                         cerebral hemorrhage) or severe neurological diseases; ⑥ Patients with&#xD;
                         incomplete data or who withdraw from treatment midway.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mingze Zhao, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Xi'an No.3 Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mingze Chang, PhD</last_name>
      <phone>029+8661816100</phone>
      <email>changmingze191@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xi'an No3 Hospital</name>
        <address>
          <city>Xi'an</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Mingze Chang</last_name>
        <phone>changmingze191@163.com</phone>
        <email>changmingze191@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Yong Zhao</last_name>
        <phone>13289867381@163.com</phone>
        <email>13289867381@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Vertigo</mesh_term>
      <mesh_term>Benign Paroxysmal Positional Vertigo</mesh_term>
      <mesh_term>Dizziness</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betahistine</mesh_term>
    </intervention_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/NCT06001047
  org study id: ACURS
  nct id: NCT06001047
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular
        disorder, and currently, manual repositioning techniques are often used for treatment.
        However, up to 30%-50% of patients may experience residual symptoms such as non-rotational
        dizziness, heaviness, instability, and emotional disturbances even after successful
        repositioning, which significantly impacts their daily functioning and quality of life.
        Electroacupuncture therapy has been proven to be an effective treatment for dizziness and has
        been applied to various vestibular disorder patients. However, the efficacy of
        electroacupuncture on the residual effects of successfully repositioned BPPV patients remains
        unclear. This study aims to explore the effectiveness of three regimens: electroacupuncture,
        betahistine in patients with residual symptoms after successful manual repositioning.
  Research objectives:
  
          1. Explore the risk factors that influence residual effects after BPPV and develop a
             predictive score chart.
  
          2. Determine the gait characteristics of patients with residual effects after successful
             repositioning of BPPV.
  
          3. Compare the clinical efficacy of different intervention strategies for the treatment of
             residual symptoms after successful repositioning of BPPV.
  
        Research subjects:
  
        From June 2023 to June 2024, patients aged between 18-65 who are first diagnosed with BPPV
        will be recruited from the outpatient and inpatient departments of the Third Hospital of
        Xi'an City, affiliated to Northwest University. For posterior canal BPPV, Epley or Semont
        maneuver will be performed; for horizontal canal BPPV, Gufoni maneuver will be performed; for
        anterior canal BPPV, Yacovino maneuver will be performed. The patients will be observed for
        30 minutes after the positioning maneuver to confirm the successful repositioning. On the
        second day after the maneuver, the follow-up personnel of the research team will contact the
        patient by phone or online to determine whether they have residual dizziness symptoms and
        whether they are willing to participate in the study. Those who agree can come to the
        hospital for reassessment to confirm the successful repositioning.
  
        Residual symptom evaluation criteria:
  
        On the 2nd day after successful repositioning, ask the patient if they have persistent
        nonspecific symptoms such as dizziness, feeling of heaviness in the head, unsteadiness, or
        floating sensation, without positional vertigo.
  
        Sample size estimation:
  
        According to the sample size design plan of randomized controlled studies, with a Type I
        error of α=0.05, a Type II error of 1-β=0.8, an incidence rate of P1=0.6 in the intervention
        group, an incidence rate of P2=0.45 in the control group, and a 1:1 ratio, 50 participants
        are allocated to each group with a total of 150 participants. Assuming a certain proportion
        of dropouts in each group, the sample size of each group required for enrollment is 60
        participants.
  
        Randomization and blinding:
  
        The postoperative patients were randomly divided into two groups: Group A (acupuncture group)
        and Group B (betahistine group) using SPSS 20.0 software. This study did not apply blinding
        to the operators or patients, while the outcome assessors and data analysts were blinded.
  
        Data collection: Baseline data including demographic information, medical history, physical
        examination, laboratory tests, and vestibular function tests were collected at enrollment.
        Dizziness Handicap Inventory (DHI) and Visual Analog Scale (VAS) scores were collected at
        baseline, 3 days after treatment, 1 week after treatment, 2 weeks after treatment, and 4
        weeks after treatment. In addition, balance function and gait tests were performed at each
        time point.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Visual Analog Scale (VAS) score
  time frame: 1weeks after treatment
  description: A scale used to evaluate the degree of dizziness in patients, scores range from 0 to 10, with higher scores indicating more severe degree of dizziness they feel.
  measure: Dizziness Handicap Inventory
  time frame: 1weeks after treatment
  description: Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
  measure: Foam posturography
  time frame: 1weeks after treatment
  description: The sponge-cushion posturing is a quantitative method for measuring postural stability. The test-retest reliability of sponge-cushion posturing is good (ICC = 0.887-0.973)
  arm group label: Group A (acupuncture group)
  arm group type: Experimental
  description: Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture
  arm group label: Group B (betahistine group)
  arm group type: Active Comparator
  description: Treatment patients with residual symptoms after successful manual repositioning by oral betahistine
  intervention type: Procedure
  intervention name: Group A
  description: Acupoint selection: The location of the vertigo-auditory area follows the positioning standard of Jiao Shunfa's Head Acupuncture. Operation: Electroacupuncture stimulation in the vertigo-auditory area of affected side. Pulse electrotherapy produced by Wujin Changcheng Medical Instrument. Sparse-dense waveforms are selected, with a voltage of 2-4V, a frequency of 60-80 times/min, and the intensity is determined by the patient's tolerance. The needle is in affected side for 30 minutes, and treatment is given once daily for a total of 5 days.
  arm group label: Group A (acupuncture group)
  other name: Scalp acupuncture
  intervention type: Drug
  intervention name: Group B
  description: The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as "Minshilang" in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd. The dosage is 12mg, three times a day (Tid) for four consecutive weeks. Compliance monitoring is conducted by counting the remaining tablets in the medication packaging box brought by patients during the 4-week follow-up period. Concurrent use of other medications that may affect the observation results, such as anti-anxiety drugs, vestibular suppressants, and anti-dizziness Chinese patent medicines, is considered a violation of the protocol.
  arm group label: Group B (betahistine group)
  other name: betahistine group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Mingze Zhao, PhD
  role: Study Chair
  affiliation: Xi'an No.3 Hospital
  last name: Mingze Chang, PhD
  phone: 029+8661816100
  email: changmingze191@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Vertigo
  mesh term: Benign Paroxysmal Positional Vertigo
  mesh term: Dizziness
  mesh term: Betahistine
  sharing ipd: No