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Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual repositioning maneuver | Active Comparator | 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) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV-chair | Device | Repositioning maneuvers in TRV-chair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatments | Number of treatment necessary to achieve resolution of vertigo and nystagmus | 2 years |
| Treatment success after first treatment | Number of subjects achieving resolution of vertigo and nystagmus after one treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory (DHI) questionnaire | Comparison of pre-treatment score and post-treatment score | 2 years |
| Adverse events | Registration of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan D Hougaard, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Head & Neck Surgery and Audiology | Aalborg | North Denmark | 9000 | Denmark |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| D014717 | Vertigo |
| D004244 | Dizziness |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
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| Manual repositioning maneuver | Procedure | Treatment with manual repositioning maneuver |
|
| 2 years |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |