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Chuna Manual Therapy for Cervicogenic Dizziness (CHERIE)

Primary Purpose

Cervicogenic Dizziness

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chuna Manual Therapy
Usual care
Sponsored by
Kyunghee University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Dizziness

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Korean Medicine Hospital
  • Kyung Hee University Korean Medicine Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chuna Manual Therapy (CMT)

Usual Care (UC)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline Dizziness Handicap Inventory (DHI) score at week 6

Secondary Outcome Measures

Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
Changes from baseline Mean Vertigo Score (MVS) at each measurement week
Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
Changes from baseline Frequency of Dizziness score at each measurement week
Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
Changes from baseline Neck Disability Index (NDI) score at each measurement week
Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
Global Perceived Effect (GPE) score at each measurement week
Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week

Full Information

First Posted
September 19, 2017
Last Updated
January 2, 2018
Sponsor
Kyunghee University
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1. Study Identification

Unique Protocol Identification Number
NCT03291912
Brief Title
Chuna Manual Therapy for Cervicogenic Dizziness
Acronym
CHERIE
Official Title
Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565).
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Dizziness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chuna Manual Therapy (CMT)
Arm Type
Experimental
Arm 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 Title
Usual Care (UC)
Arm Type
Active Comparator
Arm 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(s)
Chuna Manual Therapy
Intervention 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)
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention 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
Primary Outcome Measure Information:
Title
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
Time Frame
Week 0, Week 6
Secondary Outcome Measure Information:
Title
Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
Time Frame
Week 0, Week 3
Title
Changes from baseline Mean Vertigo Score (MVS) at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline Frequency of Dizziness score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline Neck Disability Index (NDI) score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Global Perceived Effect (GPE) score at each measurement week
Time Frame
Week 6
Title
Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Title
Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
Time Frame
Week 0, Week 3, Week 6
Other Pre-specified Outcome Measures:
Title
New Blinding Index (New BI)
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euiju Lee, Ph.D.
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
State/Province
Special Seoul City
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Kyung Hee University Korean Medicine Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25220110
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.
Results Reference
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PubMed Identifier
26218949
Citation
Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
Results Reference
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PubMed Identifier
24057828
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.
Results Reference
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PubMed Identifier
13279136
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.
Results Reference
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PubMed Identifier
11153554
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.
Results Reference
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PubMed Identifier
15681263
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.
Results Reference
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PubMed Identifier
23078200
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.
Results Reference
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PubMed Identifier
8822677
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.
Results Reference
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PubMed Identifier
11034885
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.
Results Reference
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PubMed Identifier
27419118
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.
Results Reference
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Chuna Manual Therapy for Cervicogenic Dizziness

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