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Chuna Manual Therapy for Cervicogenic Dizziness (CHERIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03291912
Recruitment Status : Withdrawn (This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565).)
First Posted : September 25, 2017
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Lee Eui-ju, Kyunghee University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervicogenic Dizziness Procedure: Chuna Manual Therapy Procedure: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline Dizziness Handicap Inventory (DHI) score at week 6 [ Time Frame: Week 0, Week 6 ]

Secondary Outcome Measures :
  1. Change from baseline Dizziness Handicap Inventory (DHI) score at week 3 [ Time Frame: Week 0, Week 3 ]
  2. Changes from baseline Mean Vertigo Score (MVS) at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  3. Changes from baseline Visual Analogue Scale (VAS) score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  4. Changes from baseline Frequency of Dizziness score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  5. Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  6. Changes from baseline Neck Disability Index (NDI) score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  7. Changes from baseline Cervical Range of Motion (CROM) value at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  8. Global Perceived Effect (GPE) score at each measurement week [ Time Frame: Week 6 ]
  9. Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]
  10. Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week [ Time Frame: Week 0, Week 3, Week 6 ]

Other Outcome Measures:
  1. New Blinding Index (New BI) [ Time Frame: Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291912


Locations
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Korea, Republic of
Kyung Hee University Korean Medicine Hospital
Seoul, Special Seoul City, Korea, Republic of, 02447
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Korea, Republic of, 05278
Sponsors and Collaborators
Kyunghee University
Investigators
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Principal Investigator: Euiju Lee, Ph.D. Kyunghee University

Publications:

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Responsible Party: Lee Eui-ju, Professor, Ph.D. KMD., Kyunghee University
ClinicalTrials.gov Identifier: NCT03291912     History of Changes
Other Study ID Numbers: HB16C0010-CMT
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases