Comparison of EM and SM+ Maneuvers in Patients With BPPV

Ludwig Maximilian University of Munich

Status: Completed

Conditions: BPPV

Treatments: Procedure: SemontPLUS maneuver; Procedure: Epley Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT05853328

20-072

Details and patient eligibility

About

Objective of this prospective randomized treatment trial is to compare the effectiveness of the SemontPLUS (SM+) with the Epley maneuver (EM) for the therapy of posterior canal benign paroxysmal positional vertigo canalolithiasis (pcBPPV).

Full description

BPPV is the second most common form of vertigo. Reported prevalence ranges from 10 to 140 per 100,000 and lifetime prevalence is at least 2.4%; prevalence of 9-11% have been found in a population older than 75 years.

The leading symptom is recurrent attacks of spinning vertigo, each triggered by changes in position relative to gravity and lasting from seconds to one minute. The cause is usually freely moving otoconia in the posterior arcuate canal (so-called canalolithiasis); the horizontal canal is affected much less frequently. In 70% of patients there is a spontaneous remission within days. In case of persistence, about 95% of patients can be successfully treated with so-called freeing maneuvers, e.g., the Sémont maneuver. However, this often requires 20 to 30 maneuvers over several days.

Based on

1. our own biophysical studies, which we performed together with colleagues from Switzerland on a mechanical model of positional vertigo and which show that theoretically 24 the effectiveness of the Sémont maneuvers can be increased by changing the positional angle by 30° in the so-called step two of the positional maneuvers, as well as
2. an analysis of the comparison of the conventional Sémont maneuver with the so-called SémontPLUS maneuver, which shows that the mean time to freedom from symptoms for the Sémont maneuver is 3.9 days and only 2.3 days for the SémontPLUS maneuver (p<0.05), the efficacy of the Epley maneuver will be compared with the SemontPLUS maneuver in a parallel group design.

The primary endpoint is the duration, i.e., days ("mornings") until freedom from symptoms with continuation of the two maneuvers in the following days, three times in the morning, at noon and in the evening. This is assessed by the patient's statements that he/she can still induce rotational vertigo or not during the positioning maneuvers to the affected side performed by him/herself.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject (≥ 18 years of age) meets diagnostic criteria for the current presence of BPPV of a posterior arcuate duct (8):

History: rotary vertigo attacks triggered by head or body position change. Duration: < 1 minute, associated with nausea, vomiting, oscillopsia

Findings: When positioned to the affected ear: torsional and vertically to the forehead beating, exhaustive nystagmus with crescendo-decrescendo-like course.

Exclusion criteria

• Subjects not capable of giving consent
• Respondent does not want therapy for BPPV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Epley Maneuver

Active Comparator group

Description:

The SOC therapy for this patient population is Physical Therapy. No medication or medical device therapy was included. In addition to SOC, patients in this arm were allocated to Epley Maneuver. The first treatment maneuver was performed once by a physician according to the assigned treatment group. The patient simultaneously received verbal instructions on how to perform the maneuver. Fifteen minutes after the first diagnostic maneuver, a second diagnostic maneuver was carried out in order to evaluate the effect of a single maneuver. For the self-maneuvers, patients received written instructions with figures on how to perform the EM independently in a home environment. For the self-maneuver at home, the modified Epley self-maneuver was done by the patient with a pillow under the shoulders. The frequency at home was three times in the morning, three times at noon, and three times in the evening, i.e., nine times per day.

Treatment:

Procedure: Epley Maneuver

SemontPLUS Maneuver

Active Comparator group

Description:

The SOC therapy for this patient population is Physical Therapy. No medication or medical device therapy was included. In addition to SOC, patients in this arm were allocated to the SemontPLUS Maneuver. The first treatment maneuver was performed once by a physician according to the assigned treatment group. For the SM+, the angle of the 60° overextended head and body was measured by an inclinometer application. The patient simultaneously received verbal instructions on how to perform the maneuver. Fifteen minutes after the first diagnostic maneuver, a second diagnostic maneuver was carried out in order to evaluate the effect of a single maneuver. For the self-maneuvers, patients received written instructions with figures on how to perform the SM+ independently in a home environment. The frequency at home was three times in the morning, three times at noon, and three times in the evening, i.e., nine times per day.

Treatment:

Procedure: SemontPLUS maneuver