The Effect of Vestibular Exercise, With or Without Medication, in Managing Residual Dizziness After Successful Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo
Overview
- Phase
- N/A
- Intervention
- Exercise-based vestibular rehabilitation
- Conditions
- Vestibular Disorder
- Sponsor
- Eye & ENT Hospital of Fudan University
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Balance function
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Huawei Li, Ph.D, MD
Director of Otorhinolaryngology
Eye & ENT Hospital of Fudan University
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Arms & Interventions
Group C
Group C will receive an combination of Exercise-based VR plus Betahistine.
Intervention: Exercise-based vestibular rehabilitation
Group A
Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;
Intervention: Exercise-based vestibular rehabilitation
Group B
Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;
Intervention: Betahistine
Group C
Group C will receive an combination of Exercise-based VR plus Betahistine.
Intervention: Betahistine
Outcomes
Primary Outcomes
Balance function
Time Frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Balance function, measured by computerized dynamic posturography.
Secondary Outcomes
- 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)