Chuna Manual Therapy for Cervicogenic Dizziness

NCT ID: NCT03291912

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervicogenic Dizziness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Chuna Manual Therapy

Intervention Type PROCEDURE

* 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)

Usual care

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University

OTHER

Sponsor Role lead

Responsible Party

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Lee Eui-ju

Professor, Ph.D. KMD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Euiju Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University

Locations

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Kyung Hee University Korean Medicine Hospital

Seoul, Special Seoul City, South Korea

Site Status

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 25220110 (View on PubMed)

Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.

Reference Type BACKGROUND
PMID: 26218949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24057828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13279136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11153554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15681263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23078200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8822677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11034885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27419118 (View on PubMed)

Other Identifiers

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HB16C0010-CMT

Identifier Type: -

Identifier Source: org_study_id

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