<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/NCT03291912</url>
  </required_header>
  <id_info>
    <org_study_id>HB16C0010-CMT</org_study_id>
    <nct_id>NCT03291912</nct_id>
  </id_info>
  <brief_title>Chuna Manual Therapy for Cervicogenic Dizziness</brief_title>
  <acronym>CHERIE</acronym>
  <official_title>Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyunghee 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>
      This is a prospective, pragmatic, assessor-blind, randomized controlled trial to explore the&#xD;
      effectiveness of an adjuvant Chuna manual therapy (CMT) for cervicogenic dizziness of&#xD;
      Dizziness Handicap Inventory (DHI) ≥ 16 at baseline. Participants will be randomized and&#xD;
      allocated to either CMT combined with usual care (UC) group or UC group with 1:1 ratio. They&#xD;
      will receive 12 sessions of CMT or UC treatment for 6 weeks. UC consists of physical therapy&#xD;
      and patients education.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565).&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Change from baseline Dizziness Handicap Inventory (DHI) score at week 6</measure>
    <time_frame>Week 0, Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Dizziness Handicap Inventory (DHI) score at week 3</measure>
    <time_frame>Week 0, Week 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Mean Vertigo Score (MVS) at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Visual Analogue Scale (VAS) score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Frequency of Dizziness score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Neck Disability Index (NDI) score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Cervical Range of Motion (CROM) value at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect (GPE) score at each measurement week</measure>
    <time_frame>Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week</measure>
    <time_frame>Week 0, Week 3, Week 6</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>New Blinding Index (New BI)</measure>
    <time_frame>Week 6</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cervicogenic Dizziness</condition>
  <arm_group>
    <arm_group_label>Chuna Manual Therapy (CMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chuna manual therapy (CMT), 2 sessions/week, 6 weeks (12 sessions in total)&#xD;
Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total)&#xD;
Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).&#xD;
Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms.&#xD;
CMT and UC group will receive the same UC regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total)&#xD;
Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).&#xD;
Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms.&#xD;
CMT and UC group will receive the same UC regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna Manual Therapy</intervention_name>
    <description>Unique manual therapy in traditional Korean medicine&#xD;
Mandatory techniques for neck part and selective techniques for other part (if necessary)&#xD;
Selective techniques depends on a patient's condition (judged by traditional Korean medicine doctor)</description>
    <arm_group_label>Chuna Manual Therapy (CMT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Physical therapy based on traditional Korean medicine theory&#xD;
Electrical stimulation: either Meridian muscle interferential current electricity or Meridian transcutaneous electricity&#xD;
Heat stimulation: either Hot pack or Infrared lamp&#xD;
Patient education&#xD;
Physical and pathological explanation of cervicogenic dizziness&#xD;
Cause and risk factors of cervicogenic dizziness&#xD;
Functions of muscles related to cervicogenic dizziness&#xD;
Home exercising to self-manage cervicogenic dizziness</description>
    <arm_group_label>Chuna Manual Therapy (CMT)</arm_group_label>
    <arm_group_label>Usual Care (UC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female aged between 20 and 70&#xD;
&#xD;
          -  neck pain and/or stiffness with dizziness, which is related to movement or positioning&#xD;
             of cervical spine&#xD;
&#xD;
          -  recurring symptom of dizziness over 1 month or more&#xD;
&#xD;
          -  Dizziness Handicap Inventory ≥ 16 at baseline&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dizziness induced by vestibular disorders (e.g., benign paroxysmal positional vertigo,&#xD;
             peripheral vestibulopathy, Meniere disease, vestibular neuronitis)&#xD;
&#xD;
          -  dizziness induced by central nervous system (CNS) disorders (e.g., cerebellar&#xD;
             ataxia,cerebellum infarction/hemorrhage, demyelination, vertebrobasilar insufficiency,&#xD;
             seizure, increased intracranial pressure, Parkinson's disease, migraines)&#xD;
&#xD;
          -  dizziness induced by cardiovascular disorders (e.g., arrhythmia, heart valvular&#xD;
             disease, anemia, orthostatic hypotension, coronary artery disease)&#xD;
&#xD;
          -  dizziness induced by active or uncontrolled disease (e.g., uncontrolled diabetes&#xD;
             mellitus, hypertension, respiratory or endocrinological disorders)&#xD;
&#xD;
          -  dizziness induced by side effects of medications&#xD;
&#xD;
          -  severe chronic or terminal diseases (malignant cancer, tuberculosis, etc.)&#xD;
&#xD;
          -  chronic psychiatric diseases under treatment (epilepsy, depression, panic disorder,&#xD;
             etc.)&#xD;
&#xD;
          -  conditions where CMT are forbidden (spinal tumor, acute fracture, infectious&#xD;
             spondylopathy, congenital malformations of spine, operation history of spine within 3&#xD;
             months, progressive neurological damage, severe neurological symptoms, spinal fixation&#xD;
             devices, syringomyelia, hydrocephaly)&#xD;
&#xD;
          -  Treatment history within 1 week for cervicogenic dizziness (NSAIDs, steroid, herbal&#xD;
             drug, acupuncture, manual therapy)&#xD;
&#xD;
          -  Women of (suspected) pregnancy or breast-feeding&#xD;
&#xD;
          -  Suspicion of alcohol and/or drug abuse&#xD;
&#xD;
          -  Participation in another clinical study within 1 month&#xD;
&#xD;
          -  Difficulty in communicating with the investigators&#xD;
&#xD;
          -  Other reasons for ineligibility of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Euiju Lee, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyung Hee University Korean Medicine Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Special Seoul City</state>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Korean Medicine Hospital at Gangdong</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Reid SA, Callister R, Snodgrass SJ, Katekar MG, Rivett DA. Manual therapy for cervicogenic dizziness: Long-term outcomes of a randomised trial. Man Ther. 2015 Feb;20(1):148-56. doi: 10.1016/j.math.2014.08.003. Epub 2014 Aug 27.</citation>
    <PMID>25220110</PMID>
  </reference>
  <reference>
    <citation>Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.</citation>
    <PMID>26218949</PMID>
  </reference>
  <reference>
    <citation>Yacovino DA, Hain TC. Clinical characteristics of cervicogenic-related dizziness and vertigo. Semin Neurol. 2013 Jul;33(3):244-55. doi: 10.1055/s-0033-1354592. Epub 2013 Sep 21.</citation>
    <PMID>24057828</PMID>
  </reference>
  <reference>
    <citation>RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.</citation>
    <PMID>13279136</PMID>
  </reference>
  <reference>
    <citation>Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.</citation>
    <PMID>11153554</PMID>
  </reference>
  <reference>
    <citation>Reid SA, Rivett DA. Manual therapy treatment of cervicogenic dizziness: a systematic review. Man Ther. 2005 Feb;10(1):4-13. doi: 10.1016/j.math.2004.03.006.</citation>
    <PMID>15681263</PMID>
  </reference>
  <reference>
    <citation>Reid SA, Rivett DA, Katekar MG, Callister R. Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2012 Oct 18;13:201. doi: 10.1186/1471-2474-13-201.</citation>
    <PMID>23078200</PMID>
  </reference>
  <reference>
    <citation>Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.</citation>
    <PMID>8822677</PMID>
  </reference>
  <reference>
    <citation>Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357.</citation>
    <PMID>11034885</PMID>
  </reference>
  <reference>
    <citation>Minguez-Zuazo A, Grande-Alonso M, Saiz BM, La Touche R, Lara SL. Therapeutic patient education and exercise therapy in patients with cervicogenic dizziness: a prospective case series clinical study. J Exerc Rehabil. 2016 Jun 30;12(3):216-25. doi: 10.12965/jer.1632564.282. eCollection 2016 Jun.</citation>
    <PMID>27419118</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University</investigator_affiliation>
    <investigator_full_name>Lee Eui-ju</investigator_full_name>
    <investigator_title>Professor, Ph.D. KMD.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03291912
org study id: HB16C0010-CMT
nct id: NCT03291912
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, pragmatic, assessor-blind, randomized controlled trial to explore the
      effectiveness of an adjuvant Chuna manual therapy (CMT) for cervicogenic dizziness of
      Dizziness Handicap Inventory (DHI) ≥ 16 at baseline. Participants will be randomized and
      allocated to either CMT combined with usual care (UC) group or UC group with 1:1 ratio. They
      will receive 12 sessions of CMT or UC treatment for 6 weeks. UC consists of physical therapy
      and patients education.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
time frame: Week 0, Week 6
measure: Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
time frame: Week 0, Week 3
measure: Changes from baseline Mean Vertigo Score (MVS) at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline Frequency of Dizziness score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline Neck Disability Index (NDI) score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Global Perceived Effect (GPE) score at each measurement week
time frame: Week 6
measure: Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
time frame: Week 0, Week 3, Week 6
measure: New Blinding Index (New BI)
time frame: Week 6
arm group label: Chuna Manual Therapy (CMT)
arm group type: Experimental
description: Chuna manual therapy (CMT), 2 sessions/week, 6 weeks (12 sessions in total)
Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total)
Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms.
CMT and UC group will receive the same UC regimen.
arm group label: Usual Care (UC)
arm group type: Active Comparator
description: Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total)
Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms.
CMT and UC group will receive the same UC regimen.
intervention type: Procedure
intervention name: Chuna Manual Therapy
description: Unique manual therapy in traditional Korean medicine
Mandatory techniques for neck part and selective techniques for other part (if necessary)
Selective techniques depends on a patient's condition (judged by traditional Korean medicine doctor)
arm group label: Chuna Manual Therapy (CMT)
intervention type: Procedure
intervention name: Usual care
description: Physical therapy based on traditional Korean medicine theory
Electrical stimulation: either Meridian muscle interferential current electricity or Meridian transcutaneous electricity
Heat stimulation: either Hot pack or Infrared lamp
Patient education
Physical and pathological explanation of cervicogenic dizziness
Cause and risk factors of cervicogenic dizziness
Functions of muscles related to cervicogenic dizziness
Home exercising to self-manage cervicogenic dizziness
arm group label: Chuna Manual Therapy (CMT)
arm group label: Usual Care (UC)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Euiju Lee, Ph.D.
role: Principal Investigator
affiliation: Kyunghee University
facility: 
facility: 
country: Korea, Republic of
citation: Reid SA, Callister R, Snodgrass SJ, Katekar MG, Rivett DA. Manual therapy for cervicogenic dizziness: Long-term outcomes of a randomised trial. Man Ther. 2015 Feb;20(1):148-56. doi: 10.1016/j.math.2014.08.003. Epub 2014 Aug 27.
PMID: 25220110
citation: Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
PMID: 26218949
citation: Yacovino DA, Hain TC. Clinical characteristics of cervicogenic-related dizziness and vertigo. Semin Neurol. 2013 Jul;33(3):244-55. doi: 10.1055/s-0033-1354592. Epub 2013 Sep 21.
PMID: 24057828
citation: RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
PMID: 13279136
citation: Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.
PMID: 11153554
citation: Reid SA, Rivett DA. Manual therapy treatment of cervicogenic dizziness: a systematic review. Man Ther. 2005 Feb;10(1):4-13. doi: 10.1016/j.math.2004.03.006.
PMID: 15681263
citation: Reid SA, Rivett DA, Katekar MG, Callister R. Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2012 Oct 18;13:201. doi: 10.1186/1471-2474-13-201.
PMID: 23078200
citation: Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.
PMID: 8822677
citation: Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357.
PMID: 11034885
citation: Minguez-Zuazo A, Grande-Alonso M, Saiz BM, La Touche R, Lara SL. Therapeutic patient education and exercise therapy in patients with cervicogenic dizziness: a prospective case series clinical study. J Exerc Rehabil. 2016 Jun 30;12(3):216-25. doi: 10.12965/jer.1632564.282. eCollection 2016 Jun.
PMID: 27419118
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University
investigator full name: Lee Eui-ju
investigator title: Professor, Ph.D. KMD.
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: Undecided