Chuna Manual Therapy for Cervicogenic Dizziness (CHERIE)

January 2, 2018 updated by: Lee Eui-ju, Kyunghee University

Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05278
        • Kyung Hee University Korean Medicine Hospital at Gangdong
    • Special Seoul City
      • Seoul, Special Seoul City, Korea, Republic of, 02447
        • Kyung Hee University Korean Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female aged between 20 and 70
  • neck pain and/or stiffness with dizziness, which is related to movement or positioning of cervical spine
  • recurring symptom of dizziness over 1 month or more
  • Dizziness Handicap Inventory ≥ 16 at baseline
  • Informed consent

Exclusion Criteria:

  • dizziness induced by vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, Meniere disease, vestibular neuronitis)
  • dizziness induced by central nervous system (CNS) disorders (e.g., cerebellar ataxia,cerebellum infarction/hemorrhage, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines)
  • dizziness induced by cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease)
  • dizziness induced by active or uncontrolled disease (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders)
  • dizziness induced by side effects of medications
  • severe chronic or terminal diseases (malignant cancer, tuberculosis, etc.)
  • chronic psychiatric diseases under treatment (epilepsy, depression, panic disorder, etc.)
  • conditions where CMT are forbidden (spinal tumor, acute fracture, infectious spondylopathy, congenital malformations of spine, operation history of spine within 3 months, progressive neurological damage, severe neurological symptoms, spinal fixation devices, syringomyelia, hydrocephaly)
  • Treatment history within 1 week for cervicogenic dizziness (NSAIDs, steroid, herbal drug, acupuncture, manual therapy)
  • Women of (suspected) pregnancy or breast-feeding
  • Suspicion of alcohol and/or drug abuse
  • Participation in another clinical study within 1 month
  • Difficulty in communicating with the investigators
  • Other reasons for ineligibility of participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chuna Manual Therapy (CMT)
  1. Chuna manual therapy (CMT), 2 sessions/week, 6 weeks (12 sessions in total)

  2. 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.
Procedure: Chuna Manual Therapy
  • 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)
Procedure: Usual care

  1. 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

  2. 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
Active Comparator: Usual Care (UC)

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.
Procedure: Usual care

  1. 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

  2. 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
Time Frame: Week 0, Week 6
Week 0, Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
Time Frame: Week 0, Week 3
Week 0, Week 3
Changes from baseline Mean Vertigo Score (MVS) at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline Frequency of Dizziness score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline Neck Disability Index (NDI) score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Global Perceived Effect (GPE) score at each measurement week
Time Frame: Week 6
Week 6
Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6
Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
Time Frame: Week 0, Week 3, Week 6
Week 0, Week 3, Week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
New Blinding Index (New BI)
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyunghee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HB16C0010-CMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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