Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
| Registry | NCT03291912, acronym CHERIE |
|---|---|
| Status | Withdrawn - This registration has moved to a local ICTRP (CRIS; https://cris.nih.go.kr, KCT0002565). |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Sponsor | Kyunghee University (Other) |
| Conditions | Cervicogenic Dizziness |
| Interventions | Chuna Manual Therapy, Usual care (Procedure) |
| Dates | start 2018-03-01 (estimated), primary completion 2019-12-31 (estimated), completion 2019-12-31 (estimated), first posted 2017-09-25, last updated 2018-01-03 |
| Locations | 2 sites in South Korea |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Chuna Manual Therapy (CMT) | Experimental | Procedure: Chuna Manual Therapy; Procedure: Usual care | 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. |
| Usual Care (UC) | Active comparator | Procedure: Usual care | 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. |
Sex: All, ages: 20 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kyung Hee University Korean Medicine Hospital | Seoul, Special Seoul City | South Korea | |
| Kyung Hee University Korean Medicine Hospital at Gangdong | Seoul | South Korea |