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Completed

NCT Number: NCT05853328

Comparison of EM and SM+ Maneuvers in Patients With BPPV

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ENT, AZ Sint-Jan Brugge-Oostende AV, Ostend, Flanders, Belgium

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About this study

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

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epley maneuver

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

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.

Primary outcomes

  1. Number of days until no positional vertigo could be induced

    Time frame: 28 days

    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.

Secondary outcomes

  1. Effect of the single maneuver performed by the physician.

    Time frame: 28 days

    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.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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