Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Aalborg University Hospital
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Number of treatments
Study Overview
Brief Summary
Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).
Detailed Description
Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age above 18 years
- •Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
- •Understand written and spoken Danish
Exclusion Criteria
- •Pregnancy
- •Weight ≥ 150 kg and or Height ≥ 2m
- •Not possible to attend follow-up visits
- •Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair
- •Have received treatment for BPPV in a mechanical rotational chair within the last 6 months
- •Sedative antihistamines are taken within the past 7 days
- •Comorbidities: Heart failure (EF<40), known cerebral aneurysm, cerebrovascular events (<3 months), and dissection disease
- •Spontaneous or gaze evoked nystagmus.
Arms & Interventions
the Epley Maneuver
Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.
Intervention: The Epley Maneuver (Procedure)
the Epley Maneuver
Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.
Intervention: Mechanical rotational chair (Device)
the 360 Maneuver
Treatment of BPPV with the 360 Maneuver in the TRV chair.
Intervention: The 360 Degree Maneuver (Procedure)
the 360 Maneuver
Treatment of BPPV with the 360 Maneuver in the TRV chair.
Intervention: Mechanical rotational chair (Device)
Outcomes
Primary Outcomes
Number of treatments
Time Frame: 2 year
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment
Time Frame: 2 year
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Secondary Outcomes
- Adverse events(2 year)
- Dizziness Handicap Inventory (DHI) Questionnaire(2 year)
- Recurrence rate(2 year)
Investigators
Malene Hentze Hansen
medical doctor
Aalborg University Hospital