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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Epley Maneuver | Active Comparator | Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used. |
|
| the 360 Maneuver | Active Comparator | Treatment of BPPV with the 360 Maneuver in the TRV chair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Epley Maneuver | Procedure | 5 step procedure where the patient:
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success after first treatment | Number of subjects achieving resolution of vertigo and nystagmus after one treatment | 2 year |
| Number of treatments | Number of treatment necessary to achieve resolution of vertigo and nystagmus | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory (DHI) Questionnaire | Comparison of pre-treatment score and post-treatment score | 2 year |
| Adverse events | Registration of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malene Hentze Hansen, MD | Department of Otolaryngology, Head & Neck Surgery and Audiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital | 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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|
| The 360 Degree Maneuver | Procedure | 5 step procedure where the patient:
|
|
| Mechanical rotational chair | Device | TRV chair |
|
| 2 year |
| Recurrence rate | Recurrence of BPPV 3 and 6 months after successful treatment. | 2 year |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |