TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo

Not Applicable

Completed

• Conditions: BPPV
• Interventions: Procedure: Manual repositioning maneuver; Device: TRV-chair

• Registration Number: NCT03871413
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV

Detailed Description

Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-04-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Characteristic (for BPPV) positional nystagmus
• Positive Dix-Hallpike
• Positive supine roll test
• Medical history compatible with BPPV

Exclusion Criteria

• Treatment in TRV-chair within the last 6 months
• Exclusion of BPPV diagnosis
• Lack of treatment cooperation
• Known cerebral aneurism or cerebral hemorrhage
• Diagnosed and treated for BPPV within the past month
• Treatment with sedating anti-histamines within the past 7 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual repositioning maneuver	Manual repositioning maneuver	Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used.
Treatment in mechanical rotational chair (TRV-chair)	TRV-chair	Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position. In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position.

Primary Outcome Measures

Name	Time	Method
Number of treatments	2 years	Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment	2 years	Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI) questionnaire	2 years	Comparison of pre-treatment score and post-treatment score
Adverse events	2 years	Registration of adverse events

Trial Locations

Locations (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology; 🇩🇰 Aalborg, North Denmark Region, Denmark