Cervicogenic Dizziness
Conditions
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.
Interventions
PROCEDUREChuna 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)
PROCEDUREUsual 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
Sponsors
Kyunghee University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Dizziness Handicap Inventory (DHI) score at week 6 | Week 0, Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Dizziness Handicap Inventory (DHI) score at week 3 | Week 0, Week 3 |
| Changes from baseline Mean Vertigo Score (MVS) at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline Visual Analogue Scale (VAS) score at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline Frequency of Dizziness score at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline Cervical Range of Motion (CROM) value at each measurement week | Week 0, Week 3, Week 6 |
| Global Perceived Effect (GPE) score at each measurement week | Week 6 |
| Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week | Week 0, Week 3, Week 6 |
| Changes from baseline Neck Disability Index (NDI) score at each measurement week | Week 0, Week 3, Week 6 |
Other
| Measure | Time frame |
|---|---|
| New Blinding Index (New BI) | Week 6 |
Countries
South Korea
Outcome results
None listed