NCT03291912撤回不适用
Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
Kyunghee University4 个研究点 分布在 2 个国家开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
时间窗: Week 0, Week 6
次要结局
- 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)
- Changes from baseline Mean Vertigo Score (MVS) at each measurement week(Week 0, Week 3, Week 6)
- Global Perceived Effect (GPE) score at each measurement week(Week 6)
- Changes from baseline Visual Analogue Scale (VAS) score at each measurement week(Week 0, Week 3, Week 6)
研究者
Lee Eui-ju
Professor, Ph.D. KMD.
Kyunghee University
研究点 (4)
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