Comparison of EM and SM+ Maneuvers in Patients With BPPV

BPPV Clinical Trial

Official title:

Benign Peripheral Paroxysmal Positional Vertigo (BPPV): Comparison of the Epley Maneuver With the So-called SémontPLUS Liberation Maneuver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853328
• Other study ID #: 20-072
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: April 7, 2022

Study information

• Verified date: May 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 7, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BPPV
• Vertigo

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Department of ENT, AZ Sint-Jan Brugge-Oostende AV	Oostende	Flanders
Germany	Department of Neurology, Ludwig Maximilian University	Munich	Bavaria
Italy	Department of ENT, University of Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days until no positional vertigo could be induced	Patients had to document whether they could provoke positional vertigo every morning. The primary endpoint was the number of days until no positional vertigo could be induced on three subsequent mornings.	28 days
Secondary	Effect of the single maneuver performed by the physician.	How many patients in both treatment groups become vertigo and nystagmus-free after a single performance of the allocated treatment maneuver performed by a physician.	28 days