Cervicogenic DizzinessCHERIENCT03291912
Chuna Manual Therapy for Cervicogenic Dizziness
A study testing Chuna Manual Therapy in people with Cervicogenic Dizziness, run by Kyunghee University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cervicogenic Dizziness
- What is being tested?
- Chuna Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyung Hee University Korean Medicine Hospital
Seoul, Special Seoul City, 02447
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, 05278
About this study
Official title: 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.
- Conditions
- Cervicogenic Dizziness
- Being tested
- Chuna Manual Therapy, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuna Manual TherapyProcedure or surgery
- 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 careProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Chuna Manual Therapy (CMT) | Experimental | 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. Receives: Procedure: Chuna Manual Therapy; Procedure: Usual care |
| Usual Care (UC) | Active comparator | 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. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
Measured: Week 0, Week 6
Secondary outcomes (10)
Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
Measured: Week 0, Week 3
Changes from baseline Mean Vertigo Score (MVS) at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline Frequency of Dizziness score at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline Neck Disability Index (NDI) score at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
Measured: Week 0, Week 3, Week 6
Global Perceived Effect (GPE) score at each measurement week
Measured: Week 6
Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
Measured: Week 0, Week 3, Week 6
Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
Measured: Week 0, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Eui-ju, Kyunghee University
- Investigators
- Euiju Lee, Ph.D., Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291912
- Sponsor's protocol ID
- HB16C0010-CMT
- Acronym
- CHERIE
- Status last verified
- Jan 2018
- First submitted
- 19 Sep 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25220110Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
PubMed 26218949Yacovino 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.
PubMed 24057828RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
PubMed 13279136Wrisley 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.
PubMed 11153554Reid 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.
PubMed 15681263Reid 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.
PubMed 23078200Karlberg 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.
PubMed 8822677Heikkila 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.
PubMed 11034885Minguez-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.
PubMed 27419118
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03291912
- Acronym / sponsor ID
- CHERIE / HB16C0010-CMT
- Conditions
- Cervicogenic Dizziness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chuna Manual Therapy (CMT) | Experimental | Procedure: Chuna Manual Therapy, Procedure: Usual care1. 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. |
| Usual Care (UC) | Active comparator | Procedure: Usual careUsual 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Chuna Manual Therapy (CMT) |
| Usual care1. 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 | Procedure or surgery | Chuna Manual Therapy (CMT), Usual Care (UC) |
Primary outcome
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
Time frame: Week 0, Week 6
10 secondary outcomes
Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
Time frame: Week 0, Week 3
Changes from baseline Mean Vertigo Score (MVS) at each measurement week
Time frame: 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
Changes from baseline Frequency of Dizziness score at each measurement week
Time frame: 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
Changes from baseline Neck Disability Index (NDI) score at each measurement week
Time frame: 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
Global Perceived Effect (GPE) score at each measurement week
Time frame: 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
Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
Time frame: Week 0, Week 3, Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Background: PubMed 25220110Reid 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.
- Background: PubMed 26218949Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
- Background: PubMed 24057828Yacovino 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.
- Background: PubMed 13279136RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
- Background: PubMed 11153554Wrisley 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.
- Background: PubMed 15681263Reid 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.
- Background: PubMed 23078200Reid 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.
- Background: PubMed 8822677Karlberg 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.
- Background: PubMed 11034885Heikkila 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.
- Background: PubMed 27419118Minguez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euiju Lee, Ph.D. principal investigator
Kyunghee University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chuna Manual Therapy in people with Cervicogenic Dizziness, run by Kyunghee University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6 (time frame: Week 0, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291912, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.