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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

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)

March 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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