Comparison of EM and SM+ Maneuvers in Patients With BPPV

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

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).

Study Overview

• Status: Completed
• Conditions: BPPV
• Intervention / Treatment: Procedure: Epley Maneuver; Procedure: SemontPLUS maneuver

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Oostende, Flanders, Belgium, 8400
      • Department of ENT, AZ Sint-Jan Brugge-Oostende AV
• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Department of Neurology, Ludwig Maximilian University
• Italy
  • Siena, Italy, 53100
    • Department of ENT, University of Siena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Michael Strupp, LMU University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Benign paroxysmal positional vertigo; Epley maneuver; SemontPLUS maneuver
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Vertigo
• Other Study ID Numbers: 20-072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No