Comparison of EM and SM+ Maneuvers in Patients With BPPV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-04-07

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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BPPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to one of two test groups. After being randomized to the SM+ arm or the EM arm, patients will receive one initial maneuver from a physician, then subsequently performe self-maneuvers at home three times in the morning, three times at noon and three times in the evening.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epley Maneuver

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.

Group Type ACTIVE_COMPARATOR

Epley Maneuver

Intervention Type PROCEDURE

The patient is sitting with both feet on the table or bed with the head looking forward. Subsequently, they let themselves fall backwards with a pillow under the shoulder and the head is turned 45° to the right. They stay in this position for 30 seconds. Afterwards, they turn the head quickly 90° to the left side followed by a turn of the whole body to the left so that their nose is pointing at the floor. They stay in this position for another 30 seconds.

Subsequently, the patients sit themselves up with the head still turned 45° to the left. They can help themselves by using both arms. After a few seconds, they can turn the head slowly back to the neutral position facing forward.

SemontPLUS Maneuver

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.

Group Type ACTIVE_COMPARATOR

SemontPLUS maneuver

Intervention Type PROCEDURE

The patients first turn head 45° to the left. Then they extend the right arm and subsequently move the whole body by 150°+ to the right side. This position is kept for 60 seconds. Subsequently, patients move their whole body by 240° towards the non-affected side. Finally, after another 60 seconds, the patient sits up for another 60 sec.

Interventions

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Epley Maneuver

The patient is sitting with both feet on the table or bed with the head looking forward. Subsequently, they let themselves fall backwards with a pillow under the shoulder and the head is turned 45° to the right. They stay in this position for 30 seconds. Afterwards, they turn the head quickly 90° to the left side followed by a turn of the whole body to the left so that their nose is pointing at the floor. They stay in this position for another 30 seconds.

Subsequently, the patients sit themselves up with the head still turned 45° to the left. They can help themselves by using both arms. After a few seconds, they can turn the head slowly back to the neutral position facing forward.

Intervention Type PROCEDURE

SemontPLUS maneuver

The patients first turn head 45° to the left. Then they extend the right arm and subsequently move the whole body by 150°+ to the right side. This position is kept for 60 seconds. Subsequently, patients move their whole body by 240° towards the non-affected side. Finally, after another 60 seconds, the patient sits up for another 60 sec.

Intervention Type PROCEDURE

Eligibility Criteria

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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.