The Effect of Vestibular Exercise, With or Without Medication, in Managing Residual Dizziness After Successful Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo
试验速览
- 阶段
- 不适用
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Balance function
研究概览
简要总结
To investigate the effect of vestibular rehabilitation, with or without medication, on resolving residual dizziness after successful repositioning maneuvers in patients with benign paroxysmal positional.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as unilateral BPPV (unilateral posterior semicircular canal BPPV or horizontal semicircular canal BPPV) according to the clinical practice guideline issued by American Academy of Otolaryngology and head and neck surgery (AAO-HNSF) in 2017;
- •Aged 18~80 years;
- •Reporting residual symptoms after successful repositioning maneuvers;
排除标准
- •Anterior semicircular canal BPPV or multicanal BPPV;
- •Recurrent BPPV;
- •Subjects with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss;
- •Subjects with severe cervical spine disease;
- •Subjects with severe cardiovascular diseases ;
- •Subjects with known cerebral vascular disease like carotid stenosis;
- •Cognitive impairment;
- •Suspect of significant depression or anxiety as defined as a score of ≥ 8 for each respective scale of Hospital anxiety and depression scale;
- •Pregnant/ lactating or planning to become pregnant during the study period;
- •Had taken vestibulosupressant, antihistamines, and/ or ototoxic medications in the past 3 months;
研究组 & 干预措施
Group C
Group C will receive an combination of Exercise-based VR plus Betahistine.
干预措施: Exercise-based vestibular rehabilitation (Behavioral)
Group A
Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;
干预措施: Exercise-based vestibular rehabilitation (Behavioral)
Group B
Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;
干预措施: Betahistine (Drug)
Group C
Group C will receive an combination of Exercise-based VR plus Betahistine.
干预措施: Betahistine (Drug)
结局指标
主要结局
Balance function
时间窗: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Balance function, measured by computerized dynamic posturography.
次要结局
- Duration of RD symptoms(Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.)
- Quality of life assessment scale(Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.)
- Otolith function(Change from baseline at 4 weeks, 8 weeks and 12 weeks follow-up will be necessary only when the previous examine showing abnormal.)
- Daily function(Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation)
研究者
Huawei Li, Ph.D, MD
Director of Otorhinolaryngology
Eye & ENT Hospital of Fudan University