Benign Paroxysmal Positional Vertigo
Conditions
Brief summary
To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.
Detailed description
The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled study.
Interventions
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. history of vertigo associated with changes in head position 2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with Frenzel glasses or videoculography in the Head turning test 3. vertigo associated with the elicited nystagmus 4. symptom within 2 weeks 5. put one's signature on consent
Exclusion criteria
1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus 2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers 3. the patients who transited from apogeotropic from vertical canal BPPV during study 4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history 5. patients whose affected ear cannot be identified 6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded. 7. patients with cervical or lumbar spine problem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus | 2 days |
Countries
South Korea
Participant flow
Pre-assignment details
217 patients enrolled in the study but 8 retracted their agreements.
Participants by arm
| Arm | Count |
|---|---|
| Gufoni Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Gufoni | 70 |
| Vibration Vibration maneuver for apogeotropic horizontal BPPV at the first day
Vibration | 67 |
| Sham Sham maneuver for apogeotropic horizontal BPPV at the first day
Sham | 72 |
| Total | 209 |
Baseline characteristics
| Characteristic | Gufoni | Vibration | Sham | Total |
|---|---|---|---|---|
| Age, Continuous | 62.00 years STANDARD_DEVIATION 11.58 | 62.22 years STANDARD_DEVIATION 13.25 | 61.44 years STANDARD_DEVIATION 13.48 | 61.9 years STANDARD_DEVIATION 12.7 |
| Lesion side Left side | 29 participants | 30 participants | 39 participants | 98 participants |
| Lesion side Right side | 41 participants | 37 participants | 33 participants | 111 participants |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 52 Participants | 133 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 20 Participants | 76 Participants |
| Symptom duration | 3.37 days | 2.70 days | 2.52 days | 2.9 days |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 72 | 0 / 73 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 73 |
Outcome results
Primary
Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus
Time frame: 2 days
Population: 217 patients enrolled in the study but 8 retracted their agreements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gufoni | Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus | 51 participants |
| Vibration | Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus | 46 participants |
| Sham | Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus | 38 participants |
p-value: 0.0283995% CI: [1.58, 7.31]Regression, Logistic
p-value: 0.036695% CI: [1.25, 5.67]Regression, Logistic