Chuna Manual Therapy for Cervicogenic Dizziness
Not Applicable
Withdrawn
- Conditions
- Cervicogenic Dizziness
- Interventions
- Procedure: Usual careProcedure: Chuna Manual Therapy
- Registration Number
- NCT03291912
- Lead Sponsor
- Kyunghee University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care (UC) 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. Chuna Manual Therapy (CMT) 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. Chuna Manual Therapy (CMT) Chuna Manual Therapy 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.
- Primary Outcome Measures
Name Time Method Change from baseline Dizziness Handicap Inventory (DHI) score at week 6 Week 0, Week 6
- Secondary Outcome Measures
Name Time Method Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week Week 0, Week 3, 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 Change from baseline Dizziness Handicap Inventory (DHI) score at week 3 Week 0, Week 3 Changes from baseline Neck Disability Index (NDI) 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 Changes from baseline Frequency of Dizziness score at each measurement week Week 0, Week 3, Week 6 Global Perceived Effect (GPE) score at each measurement week Week 6 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
Trial Locations
- Locations (2)
Kyung Hee University Korean Medicine Hospital
🇰🇷Seoul, Special Seoul City, Korea, Republic of
Kyung Hee University Korean Medicine Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of